Job Closed
This listing is no longer active.
Headlands Research is improving patients’ lives by advancing innovative medical therapies.
Director, Clinical Quality Assurance
Location
United States + 1 moreAll locations: United States | Canada
Posted
98 days ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Director, Clinical Quality Assurance
Headlands Research
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Director of Quality is tasked with ensuring that Headlands delivers consistent, high-quality data to our pharma partners as well as ensuring patient safety during the trial process. This individual will oversee quality and training functions for the organization including, but not limited to: - Development and maintenance of quality assurance and training programs and policies - Oversight of inspections and audits - Quality diligence for acquired sites - Management of SOPs and quality documents to ensure GCP and all regulatory guidelines are adhered to In addition to strategic oversight, the Director will also serve as the Quality Leader for a group of sites, providing hands-on support in quality reviews, audit/inspection preparation, and CAPA resolution, ensuring that sites are inspection-ready and quality standards are consistently met. Direct Reports: 3-4 This individual should bring a strong background in the clinical trial industry with specific experience supporting and leading multi-site or large research organization quality development programs. Candidates should appreciate the atmosphere of a growing company and the need to impact process development while supporting sites. Success in this position requires agility, collaboration, and exceptional critical thinking and problem-solving abilities. Qualifications - Bachelor's degree in business or a health-related field required; master’s degree preferred - 5 years+ experience in clinical trials industry (sponsor or site) with experience in managing quality - 3+ years’ experience leading a team - Experience with Quality oversight in Canada preferred but not required - Prior experience authoring site SOPs preferred but not required - Fundamental knowledge of US regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations) - Ability to work in a remote setting with travel required sometimes with short notice - Demonstrates strong analytical and proactive problem-solving skills - Strong written and verbal communication skills - Exceptional organizational skills, ability to multi-task and be detail oriented - Experience developing and implementing training materials - Accomplishes work in accordance with scheduled objectives and effectively meets deadlines - Ability to maintain high degree of professionalism and integrity Requirements - Oversee and direct the Quality Department, ensuring its alignment with the broader business strategy and adherence to industry standards, while establishing clear goals and promoting a culture of quality, compliance, and ongoing improvement. - Communicate, train, and author (when applicable) Standard Operating Procedures (SOPs) including periodic review/revisions of procedures and policies to ensure compliance with regulations and guidelines in both the US and Canada. - Develop and maintain key performance indicators (KPIs) to evaluate the effectiveness of quality assurance activities and initiatives. - Conduct and/or oversee annual and monthly quality reviews. - Support the corporate development team through quality review of potential acquisition candidates. - Developing and monitoring employee training as applicable to quality, including GCP, IATA, PHI, KnowB4, etc. - Develop, implement, and maintain an internal review monitoring system and schedule. - Report out on quality trends and metrics to aid in effective process improvement and risk management. - Work with Regional Director of Operations, Quality Managers, and Site Directors to ensure quality incidents are investigated, root cause analysis is performed, and a CAPA has been implemented and monitored for effectiveness. - Partner with regional leaders and site teams to identify potential changes and opportunities for process improvement. - Provide guidance, support, training, and interpretation of regulations, guidelines, and policies. - Support coordination of sponsor audits, regulatory inspections, and mock audits. - Oversee documentation, reporting, and closure of significant compliance and/or site review findings. - Act as backup Quality Manager for all sites within the network. - Serve as the Quality Leader for assigned sites, providing direct hands-on support with quality reviews, audits/inspections, and CAPA resolution to reinforce site-level compliance and readiness. - Facilitate New Hire Orientation and onboarding in collaboration with HR for clinical operations to specific functions related to quality. - Develop and implement a mentorship program for new site employees to foster quality across the enterprise. - Facilitate CTMS training in collaboration with ESource team. Benefits
Job Requirements
- Bachelor's degree in business or a health-related field required; master’s degree preferred
- 5 years+ experience in clinical trials industry (sponsor or site) with experience in managing quality
- 3+ years’ experience leading a team
- Experience with Quality oversight in Canada preferred but not required
- Prior experience authoring site SOPs preferred but not required
- Fundamental knowledge of US regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations)
- Ability to work in a remote setting with travel required sometimes with short notice
- Demonstrates strong analytical and proactive problem-solving skills
- Strong written and verbal communication skills
- Exceptional organizational skills, ability to multi-task and be detail oriented
- Experience developing and implementing training materials
- Accomplishes work in accordance with scheduled objectives and effectively meets deadlines
- Ability to maintain high degree of professionalism and integrity
- Oversee and direct the Quality Department, ensuring its alignment with the broader business strategy and adherence to industry standards, while establishing clear goals and promoting a culture of quality, compliance, and ongoing improvement.
- Communicate, train, and author (when applicable) Standard Operating Procedures (SOPs) including periodic review/revisions of procedures and policies to ensure compliance with regulations and guidelines in both the US and Canada.
- Develop and maintain key performance indicators (KPIs) to evaluate the effectiveness of quality assurance activities and initiatives.
- Conduct and/or oversee annual and monthly quality reviews.
- Support the corporate development team through quality review of potential acquisition candidates.
- Developing and monitoring employee training as applicable to quality, including GCP, IATA, PHI, KnowB4, etc.
- Develop, implement, and maintain an internal review monitoring system and schedule.
- Report out on quality trends and metrics to aid in effective process improvement and risk management.
- Work with Regional Director of Operations, Quality Managers, and Site Directors to ensure quality incidents are investigated, root cause analysis is performed, and a CAPA has been implemented and monitored for effectiveness.
- Partner with regional leaders and site teams to identify potential changes and opportunities for process improvement.
- Provide guidance, support, training, and interpretation of regulations, guidelines, and policies.
- Support coordination of sponsor audits, regulatory inspections, and mock audits.
- Oversee documentation, reporting, and closure of significant compliance and/or site review findings.
- Act as backup Quality Manager for all sites within the network.
- Serve as the Quality Leader for assigned sites, providing direct hands-on support with quality reviews, audits/inspections, and CAPA resolution to reinforce site-level compliance and readiness.
- Facilitate New Hire Orientation and onboarding in collaboration with HR for clinical operations to specific functions related to quality.
- Develop and implement a mentorship program for new site employees to foster quality across the enterprise.
- Facilitate CTMS training in collaboration with ESource team.
Related Guides
Related Categories
Related Job Pages
More Director Jobs
Regional Director of Operations / Northeast
AmeritaAmerita, an affiliate of BrightSpring Health Services, is a specialty infusion company focused on providing complex pharmaceutical products and clinical services to patients outside of the hospital. Committed to excellent service, our vision is to combine the administrative efficiencies of a large organization with the flexibility, responsiveness, and entrepreneurial spirit of a local provider.
Our Company Amerita Overview Amerita, Inc. is a leading provider in home Infusion therapy. We are looking for a Regional Director of Operations to join our operations management team as we grow to be one of the top home infusion providers in the country. The Regional Director of Operations will report to the Senior Vice President of Operations. Amerita is an entrepreneurial-founded company and a wholly owned subsidiary of PharMerica. The home infusion market is positioned for rapid growth driven by the aging population, increase in chronic diseases, robust pipeline of infusible drugs coming to market, and an industry shift from hospital delivery settings to lower-cost, high-quality alternative providers such as Amerita. As a core member of the operations management team, you will be expected to support the development and implementation of pharmacy policy and ensure branch compliance with pharmacy policy, pharmacy laws and regulations and accreditation standards. The position provides additional support for hiring, training and ongoing education of branch pharmacy personnel. The Regional Director of Operations supports departments and programs such as internal audit systems, quality assurance and product/equipment evaluation. We will help you achieve your goals through continuous professional development and regular career progression discussions. Schedule: M-F Remote with travel to NY/NJ Area We Offer: • Medical, Dental & Vision Benefits plus, HSA & FSA Savings Accounts• Supplemental Coverage – Accident, Critical Illness and Hospital Indemnity Insurance• 401(k) Retirement Plan• Company paid Life and AD&D Insurance, Short-Term and Long-Term Disability• Employee Discounts• Tuition Reimbursement• Paid Time Off & Holidays Responsibilities - First-line operational and clinical resource to branch management teams for pharmacy needs - Conducts training and orientation for new Pharmacy Mangers and key pharmacy personnel - Evaluates and supports adherence to clinical and operational policies and procedures for Amerita offices in compliance with federal, state, regulatory agency and accrediting agency requirements - Identifies and enforces best practices for branch pharmacy efficiency, workflow and quality to support inter-branch consistency - Assists with the development and maintenance of a Clinical/Operations audit tool to ensure branch compliance with applicable laws, regulations, accreditation standards, and clinical standards - Participates in the development and implementation of Clinical Programs for targeted therapies/disease states - Assists branch clinical managers with the implementation of quality assurance programs and monitors QI program results and trends to provide action plans and outcome reports to the Performance Improvement Committee - Participates in the evaluation of new and current products and equipment related to patient care and makes recommendations to supervisor based on evaluations - Creates and conducts training and educational sessions for Clinical and Sales staff regarding clinical topics - Supports Sales staff with information for marketing Amerita’s clinical programs and services - Contributes to the maintenance of current information related to updates in state Board of Pharmacy Laws and Regulations - Contributes to the development of quality improvement program(s) that will support the compliance department’s reporting - Contributes to the development and implementation of Clinical and Operations policies and procedures - Works closely with VP of Operations and the Corporate Director of Clinical Services to support compliant and efficient field pharmacy operations - Is an active member of the Corporate Clinical and Therapeutics Committee Qualifications - Must be a Pharmacist or Registered Nurse with license in good standing; willing to seek additional state licensure, outside of home state, to support company operation (at company expense). - Minimum three (3) years of operations management experience in a Home Infusion setting; four to five (4-5) years of experience preferred - Extensive Home Infusion experience in the following areas: clinical, P&L management and clinical sales support - Excellent interpersonal skills - Excellent verbal and written communication skills - CPR+ pharmacy computer system knowledge a plus - Teaching and training experience - Directly supervise roughly six (6) General Managers and indirectly supervise the respective branches - Ability to travel up to 50% About our Line of Business Amerita, an affiliate of BrightSpring Health Services, is a specialty infusion company focused on providing complex pharmaceutical products and clinical services to patients outside of the hospital. Committed to excellent service, our vision is to combine the administrative efficiencies of a large organization with the flexibility, responsiveness, and entrepreneurial spirit of a local provider. For more information, please visit www.ameritaiv.com. Follow us on Facebook, LinkedIn, and X. Salary Range USD $190,000.00 - $210,000.00 / Year
Director of Implementation Services [Lansing, MI; Chicago, IL; or remote] We are looking for an experienced Director of Implementation Services to lead our rapidly growing team of Solution Consultants and Implementation & Training Specialists within our Professional Services organization. The Director of Implementation Services will oversee these teams of Subject Matter Experts as they work directly with our customers to implement the BS&A Cloud ERP solution. Reporting to the VP of Professional Services, the Director of Implementation Services will partner closely with peers leading Project Management and Data Conversion to ensure successful customer implementations while driving continuous improvement in processes and tools to maximize efficiency and speed of projects. If you’re excited about rapidly evolving and leading an Implementation Services function, we want to hear from you! Key Responsibilities: - Demonstrates understanding of best practices in implementation of complex ERP software in a SaaS delivery model. - Oversee the planning, execution, and completion of multiple implementation projects simultaneously. - Sets clear KPIs and holds team members accountable for delivering results. - Drives efficiencies in all aspects of customer implementations. - Maximizes customer satisfaction and delivers best-in-class time-to-value for customers. - Manages to predictive metrics that optimize customer experience and BS&A financial outcomes. - Drives standards through methodologies, playbooks, solution blueprints, and best practices to gain efficiency. - Forecasts staffing requirements for the Solution Consulting and Implementation & Training Specialist teams, and oversees recruiting and onboarding to deliver on those staffing requirements. - Ensures staff are constantly staying up to speed on the latest solution offerings and enhancements from BS&A, along with corresponding developments in the municipal government domain. - Provides strategic leadership to the Solution Consulting and Implementation & Training Specialist teams, fostering a culture of collaboration, innovation, and accountability, ensuring the team has the necessary resources and support to deliver high-quality projects. - Actively engages in key customer projects and remediates any challenges with execution or client satisfaction. - Provides guidance on performance management, maps clear career growth opportunities, and retains top talent. - Partners with Project Management and Data Conversion to optimize burndown of the implementation backlog. - Plans appropriately to ensure MoM, QoQ, and YoY the organization meets and/or exceeds their targets. Key Attributes: - Experienced leader that understands how to build and lead a growing Implementation Services team. - Solution oriented individual who drives best practices and simplifies complexity. - Outstanding interpersonal skills to understand how best to navigate internal and external resources to move an individual project or program forward. - Complex problem-solving skills. - Process-driven and detail oriented. - Stellar collaborator. - Builder that enjoys establishing scalable business models and fostering individual team member growth. - Ability to manage stress and anxiety levels in complex and fast paced environments Qualifications: - Minimum of 5 years leading and/or managing a large team (20+) of solution experts within a Professional Services organization, preferably with an ERP company or similar complex B2B/B2G SaaS product. - Strong leadership and team management skills. - Excellent communication and interpersonal skills, with the ability to interact effectively with clients and internal stakeholders. - Ability to work effectively across teams both in-person and remotely to obtain and share all necessary data, information, and recommendations real-time. - Prior government technology and/or municipality experience is preferred. - Bachelor’s degree or higher. - Ability to travel up to 35%, with heavier travel to our headquarters in Lansing, MI during initial onboarding and ramp-up time period. At BS&A, we love our team members and offer a highly competitive compensation and benefit package. Our benefit package includes: - Competitive pay - Health Insurance – BCBS of Michigan – Employer-paid premium - Health Savings Plan – Employer contributes 75% - Dental Insurance – Employer-paid premium - Vision Insurance – Employer-paid premium - Retirement – 401(k) contribution – Employer-paid - Retirement – 401(k) – Employer matches 50% of team member contribution - Paid Parental Leave - Disability Insurance – Employer-paid premium - Life Insurance – Employer-paid premium - Generous PTO and Holiday Time - Company-sponsored events BS&A Software uses E-Verify as part of the I-9 process to verify the work eligibility of all new hires. BS&A Software provides Equal Employment Opportunity to all employees and applicants for employment without regard to race, color, religion, gender identity or expression, sex, sexual orientation, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. BS&A Software complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.
Director of Business Excellence, Advanced Separation & Water
Kemco SystemsA CECO Environmental Brand - Redefining Efficiency Since 1969
• Own and lead the ASW Business Excellence function, setting vision, priorities, standards, and governance • Define and deploy the enterprise operating system, including KPI architecture, review cadence, and escalation mechanisms • Hold leaders accountable for performance outcomes through disciplined operating reviews and corrective action governance • Translate enterprise strategy into operational priorities, initiatives, and measurable targets • Drive margin expansion initiatives, including productivity, labor optimization, footprint efficiency, and working capital improvement • Identify and prioritize enterprise improvement initiatives that unlock growth, scalability, and profitability • Establish and enforce standardized manufacturing processes, workflows, and performance expectations across all sites • Lead capacity, footprint, and throughput strategies to support growth while controlling cost • Oversee enterprise KPI performance across Safety, Quality, Delivery, Cost, and Cash, ensuring transparency and accountability • Own the Lean and Continuous Improvement strategy, ensuring consistent deployment across all facilities • Build CI capability within operations leadership through coaching, training, and structured problem-solving • Drive waste elimination, variation reduction, and quality improvement using Lean/Six Sigma methodologies • Serve as the executive operational owner of ERP and manufacturing systems in partnership with IT • Define operational requirements for ERP, MES, automation, and analytics to enable visibility, scheduling accuracy, and execution discipline • Lead ERP optimization and adoption, ensuring systems drive behavior, accountability, and performance • Lead operational due diligence for acquisitions, assessing manufacturing capability, scalability, and integration risk • Own post-close operational integration, including process harmonization, KPI alignment, and ERP migration readiness • Ensure rapid performance stabilization and value capture post-acquisition • Champion a strong safety and quality culture, partnering with EHS and Quality leaders to embed standards and accountability • Ensure operational excellence is embedded in leadership behaviors, decision-making, and talent development
Key Account Director
DarktraceDarktrace, founded in 2013, is a global leader in cybersecurity AI, specializing in AI-driven solutions that autonomously detect and respond to cyber threats, s
Darktrace is a global leader in AI for cybersecurity that keeps organizations ahead of the changing threat landscape every day. Founded in 2013, Darktrace provides the essential cybersecurity platform protecting nearly 10,000 organizations from unknown threats using its proprietary AI. The Darktrace Active AI Security Platform™ delivers a proactive approach to cyber resilience to secure the business across the entire digital estate – from network to cloud to email. Breakthrough innovations from our R&D teams have resulted in over 200 patent applications filed. Darktrace’s platform and services are supported by over 2,400 employees around the world. To learn more, visit http://www.darktrace.com. Job Description: About the Position This is a hunter-focused role, based out of the New York, covering the North East Territory. Primarily responsible for generating net new business within a portfolio of approximately 50 strategic enterprise prospects and customers. You will collaborate closely with a dedicated support team—including an SDR, Sales Engineer, and Channel Manager—to uncover opportunities, map account structures, and strengthen relationships with key stakeholders. As a senior member of the sales team, you will be expected to navigate complex enterprise environments, influence executive decision-makers, and drive strategic outcomes across multiple business units. Key Responsibilities - Drive revenue growth through new business acquisition and upsell opportunities within a defined territory, targeting a named account list of companies with revenues ranging from $1B to $5B+. - Build and maintain a robust sales pipeline through proactive outbound prospecting, strategic partnerships with regional channel partners, and close collaboration with the marketing team. - Deliver compelling presentations and product demonstrations of Darktrace’s cyber threat defense solutions to both technical stakeholders and C-level executives. - Lead and coordinate Proof of Value (POV) engagements in partnership with Darktrace Subject Matter Experts, Technical Solution Engineers, and Cyber Threat Analysts. - Influence enterprise-wide buying decisions by engaging with senior executives, including CISOs, CIOs, and other key stakeholders. - Collaborate cross-functionally with internal teams such as product, legal, and customer success to ensure seamless onboarding and long-term customer value. - Represent Darktrace at industry events, conferences, and executive briefings, contributing to thought leadership and market visibility. Requirements - Gritty, target-driven mindset with a passion for hunting and closing new business. - Minimum of 5 years of full-cycle B2B sales experience in a technical solution environment. - Proven experience in cybersecurity sales is required. Cloud Security is a Plus. - Channel sales experience is strongly preferred. - Demonstrated success managing long sales cycles with average deal sizes of $500K+ and annual quotas exceeding $1M. - Expertise in sales forecasting and execution using a structured methodology (e.g., MEDDPICC). - Experience managing global or multi-regional enterprise accounts is a plus. - Strong communication and executive presence with the ability to build and maintain influential, long-term business relationships. - Compensation range: $320,000 - $340, 000 OTE DOE Benefits: - 100% medical, dental and vision insurance, plus dependents - Paid parental leave - Pet insurance Discount - Life insurance - Commuter benefits - 401(k) - Employee Assistance Program


