Job Closed
This listing is no longer active.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
Associate Director, GD Quality Assurance
Location
United States + 1 moreAll locations: United States | United Kingdom
Posted
93 days ago
Salary
$157K - $256K / year
Seniority
Lead
No structured requirement data.
Job Description
Associate Director, GD Quality Assurance
Regeneron Pharmaceuticals
As an Associate Director, Global Development Quality Assurance, you will play a key role supervising, guiding and leading our Good Clinical Practice (GCP) Audit Programs. Responsibilities include managing direct reports, supporting the development and execution of departmental goals and objectives. We also create strategic partnerships and oversee risk-based quality auditing activities. You will also apply your knowledge of the FDA and EU regulations and ICH guidance documents with other regulations that may affect drug development and post-authorization safety monitoring. A typical day include the following: • Manage, hire and develop direct reports at least monthly and conducting Mid-year and End-of year performance assessments. • Responsible for the training, resourcing, and individual staff development of direct reports. • Lead the identification of internal quality/compliance issues and act as a catalyst for process improvements to promote standardization and best practices. • Represent the GDQA audit function by providing audit and compliance input in cross functional meetings. • Represent GDQA on high-priority and highly visible teams, compliance projects and initiatives both within and across functional areas or other departments as applicable. • Assist managing staff resourcing (internal & external) to accomplish the annual audit schedules. • Assist assessing and prioritization of both internal and external audit needs. • Assist with the drafting and issuance of periodic metrics reports to management, cross functional groups and leadership teams as requested. • Interpret and may assist in developing policies, standards, and regulations, and evaluates potentially critical problems. • Responsible for “end to end” audit process which includes: • Scheduling, preparing, conducting, reporting, and follow-up on audits in support of routine and directed GxP audits as needed and in accordance with Regeneron standard operating procedures and quality policies. • Audits include internal audits and external audits conducted globally • Provide education and/or training to GDQA staff and other relevant Global Development departments. • May participate in regulatory inspections by acting as part of the control and/or inspection room team • This role may require 20 – 30% travel (both domestic and international) This may be for you if you: • Demonstrated skills in taking initiative and working independently • Self-motivated with the ability to work effectively in a dynamic environment with ambiguity • Ability to effectively manage multiple complex priorities and direct reports • Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations To be considered a Bachelor’s degree (Master’s degree preferred) with 11+ years of relevant industry experience including 9+ years of direct people management and/or GCP audit experience preferred. Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs. Good problem solving, written and verbal communication skills and uses professional concepts to evaluate problems and develop solutions for critical issues. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $157,200.00 - $256,600.00
Related Guides
Related Categories
Related Job Pages
More Director Jobs
• Leading and managing areas of business operations within the school • Developing and implementing plans, policies, and strategies • Creating and tracking key performance metrics • Collaborating with internal stakeholders • Managing teaching and administrative staff • Ensuring compliance with educational standards • Developing and overseeing implementation of the school’s Academic Improvement Plan
Associate Director, Financial Structuring
GE HEALTHCAREGE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Job Description Summary The Financial Structuring role supports the Enterprise Solutions and Care Alliance team in developing financial models - including specifically unitary payment / Managed Equipment Services and funded models, evaluating deal structures, and assisting in preparing proposals for long-term partnership programs. This role is designed for an analytical individual seeking to develop expertise in structured partnerships. Job Description Key Responsibilities 1. Financial Modeling & Analysis - Support development and maintenance of Managed Equipment Service (MES) financial models. - Perform data gathering, scenario analysis, and model validation. - Prepare financial summaries and pricing recommendations. 2. Bid & Proposal Support - Assist in creating financial / structure value propositions and content for Care Alliance partnership pursuits. - Help prepare internal scenario modeling for deal pursuits - Engage directly with customer stakeholders for deal financials and structuring discussions. - Coordinate with cross-functional teams for inputs. 3. Partnership Delivery & Governance Support - Support KPI tracking and reporting. - Tracking activity within partnerships to align within various GEHC functions - Help prepare financial model and technology plan variations – to include: documentation and contract updates, financial model outputs - Prepare materials for governance forums. 4. Cross-Functional Coordination - Coordinate with internal stakeholders for financial and commercial data. - Support alignment across structuring, commercial sales, legal, and finance. - Participate in meetings as required and educate deal teams on financial model and structuring considerations. 5. Quality, Compliance & Continuous Improvement - Maintain accurate documentation aligned with variation process. - Support process improvements and standard work development. - Ensure compliance and governance. Qualifications Required: - Bachelor’s degree in Finance, Economics, Accounting, Business, Engineering, or related field. - Strong analytical and financial modeling skills. - Strong Excel background - Effective written and verbal communication. - Ability to manage multiple tasks with high attention to detail. Preferred: - 5+ years of experience in finance, consulting, banking, or commercial operations. - Exposure to project finance or long-term contracts. - Experience preparing financial analyses or pricing models. - Expertise in healthcare market trends and provider partnerships. - Experience engaging with customers and provider finance teams at various levels. #LI-KC1 We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $83,600.00-$125,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No Application Deadline: April 01, 2026
• Develops and executes on field strategies that translate national direction into clear territory plans and prioritization to ensure the Company’s commitment to scientific partnership is delivered. • Manages the identification, categorization, and development of KOLs across therapeutic areas in region, ensuring minimal overlap when possible. • Assists in the development of field medical tactics and resources through translation of medical plan in conjunction with national field medical leadership. • Demonstrates leadership presence at regional and key local symposia and congresses. • Supports development, monitoring, and reporting of performance against KPIs, dashboards, and performance metrics that measure scientific engagement quality, insight depth, and operational consistency. • Supports and executes strategy development and operational execution of MSL advisory boards. • Represents the Company at advisory boards, congresses, and scientific meetings as needed. • Manages the scientific congress field medical planning activities, together with Medical Information and Scientific Communications and other Medical Affairs team members and other relevant functions, (e.g., scientific content coverage, external stakeholder engagement). • Oversees hiring, retention, training, and development of MSL team in region to ensure best-in-class performance by the team. • Contributes to initiatives that strengthen Field Medical excellence, including onboarding curricula, scientific training, competencies, skill assessments, and continuous development frameworks. • Monitors team compliance with policies and procedures and manage reporting of expenses and compliance concerns for direct reports. • Supports development, maintenance, and enforcement of policies, SOPs, and processes to guide daily compliant operations of the MSL team.
• Develops and executes on field strategies that translate national direction into clear territory plans and prioritization to ensure the Company’s commitment to scientific partnership is delivered. • Manages the identification, categorization, and development of KOLs across therapeutic areas in region, ensuring minimal overlap when possible. • Assists in the development of field medical tactics and resources through translation of medical plan in conjunction with national field medical leadership. • Demonstrates leadership presence at regional and key local symposia and congresses. • Supports development, monitoring, and reporting of performance against KPIs, dashboards, and performance metrics that measure scientific engagement quality, insight depth, and operational consistency. • Supports and executes strategy development and operational execution of MSL advisory boards. • Represents the Company at advisory boards, congresses, and scientific meetings as needed. • Manages the scientific congress field medical planning activities, together with Medical Information and Scientific Communications and other Medical Affairs team members and other relevant functions, (e.g., scientific content coverage, external stakeholder engagement). • Oversees hiring, retention, training, and development of MSL team in region to ensure best-in-class performance by the team. • Contributes to initiatives that strengthen Field Medical excellence, including onboarding curricula, scientific training, competencies, skill assessments, and continuous development frameworks. • Monitors team compliance with policies and procedures and manage reporting of expenses and compliance concerns for direct reports. • Supports development, maintenance, and enforcement of policies, SOPs, and processes to guide daily compliant operations of the MSL team.
