Job Closed

This listing is no longer active.

Senior Director, Global Sterility Assurance

DirectorDirectorFull TimeRemoteSeniorTeam 10,001+Since 2020H1B No SponsorCompany SiteLinkedIn

Location

Ireland

Posted

83 days ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglish

Job Description

Senior Director, Global Sterility Assurance

Viatris

• Oversee globally aseptic practices in the steriles manufacturing network. • Ensure adherence to evolving expectations from Health Authorities. • Create a sterility assurance program and ensure implementation in accordance with Viatris regulatory standards. • Focus on the sterility assurance culture, operations and awareness to improve the batch success rate and contamination control. • Work with Site and Global stakeholders to maintain and update the aseptic education and awareness training program. • Provides sterility assurance expertise on facility designs, flows, zone concepts, investigations, and new product introductions/tech transfers.

Job Requirements

  • Strong understanding of USP and EP, endotoxin, and sterility testing is required.
  • Comprehensive understanding of the major Regulations and Guidelines pertaining to the pharmaceutical industry.
  • Specifically GMP compliance knowledge including 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485 and Part 11 compliance.
  • Hands-on experience in complex investigations in both preventive and reactive contamination control.
  • Knowledge and experience in microbiological test technologies, efficacy studies and recovery methods.
  • Strong regulatory understanding of environmental monitoring programs that can will enable proactive assessment of controls prior to exceeded action limits.
  • Technical knowledge of clean room engineering including particle control mechanisms.

Benefits

  • Excellent career progression opportunities
  • Work-life balance initiatives
  • Bonus scheme
  • Health insurance
  • Pension

Related Categories

Related Job Pages

More Director Jobs

CooperCompanies logo

Senior Director, Authorized Distributor Channel – Managed Vision Care

CooperCompanies

A leading global medical device company committed to advancing healthcare through CooperVision and CooperSurgical.

Director83 days ago
Full TimeRemoteTeam 10,001+Since 1978H1B No Sponsor

• Lead strategic direction for Authorized Distribution, INR, and MVC channels, aligned to commercial objectives. • Analyze market trends, customer behaviors, and competitive changes to anticipate channel evolution and customer needs. • Identify high-value business development opportunities that strengthen CooperVision’s market position and create customer‑centric differentiation. • Oversee all aspects of authorized distributor relationships, including contractual negotiations, fee-for-service terms, pricing structures, inventory targets, service-level KPIs, and performance accountability. • Direct the CVI distributor team, providing coaching, goal-setting, and operational oversight. • Partner with sales and marketing leadership to ensure distributor priorities are aligned with broader commercial strategies. • Establish the strategic roadmap for key managed care partners. • Develop field execution programs that drive sales effectiveness and enhance the patient journey within managed care channels. • Collaborate with Finance to evaluate cost‑to‑serve economics and recommend profitable channel investments. • Create business plans for new commercial opportunities across distribution, managed care, and other channels. • Establish measurable KPIs and reporting cadence to monitor channel performance and operational execution.

New York
$155.8K - $236.5K / year
Job Closed
The National Wild Turkey Federation logo

Regional Director

The National Wild Turkey Federation

The NWTF is dedicated to the conservation of the wild turkey and the preservation of our hunting heritage.

Director83 days ago
Full TimeRemoteTeam 201-500Since 1973H1B No Sponsor

• Responsible for solidifying and growing new fundraising opportunities, through volunteer recruitment and personal leadership within the territory assigned. • Ensures compliance with NWTF established operating and reporting procedures for activities within their region and their personal scope of business. • Responsible for maintaining accurate volunteer and chapter contact information in NWTF data base. • Communicates with their DFO, National Headquarters staff, Regional NWTF Conservation staff, Director of Development staff, State Policy staff, Local Chapter volunteers and leaders, and State Board of Directors on a regular basis. • Works with State Chapter President, state agencies, and other NWTF staff to develop a strong State Chapter and State Super Fund to ensure effective partnerships for NWTF mission delivery within the state(s). • Acts as a representative of the company to promote NWTF, its mission, and initiatives to NWTF members, within local communities, social media, and other organizations. • Complete and submit all required documents, expenses, and reports in a timely manner. • Complete and submit event evaluations within 5 days of event. • Produce Year over Year growth for event net revenue, to include adult membership, new chapter development and maintain an event net efficiency min of 50%. • Secure, safeguard and maintain NWTF equipment and property manage inventory. • Ensures timely and professional communication with Volunteers, Members, Prospects, Peers, Supervisors, and Headquarters personnel. • Ensure to project and maintain professional behavior and appearance at all times. • Is responsible to their respective DFO for their goals and objectives including, but not limited to, annual budgeted fundraising and controllable expense levels. • Is responsible for maintaining and growing a diverse portfolio of fundraising activities in the region including, but not limited to, one annual fund-raising event per chapter which nets a minimum of 5,000 and signs up a minimum of 50 adult members, virtual fundraising events, and Upper Level membership commitments. • Attend annual NWTF Convention, regional meetings and training opportunities, as necessary. • Performs other related duties as assigned.

Louisiana
$65K / year
Job Closed
Drew University logo

Business Director

Drew University

Drew University, a Phi Beta Kappa liberal arts university, includes the College of Liberal Arts, Drew Theological School, and the Caspersen School of Graduate Studies. Drew is located on a beautiful, wooded campus in Madison, New Jersey, a thriving small town close to New York City. Drew’s one-of-a-kind, leading-edge path to an undergraduate degree, Launch, ensures that every student graduates with a purpose, sought-after transferable skills, a network of mentors, and an experience-based résumé—guaranteed. Drew’s unique, immersive learning experiences include professionally mentored scientific research in RISE and DSSI, volunteer and community-based opportunities through the Center for Civic Engagement, making industry connections in seven semesters in New York City, and exploring the world through eye-opening international study abroad trips. Drew University’s two graduate schools, Drew Theological School and the Caspersen School of Graduate Studies, confer 10 master’s and four doctoral degrees. Numerous certificate programs are also available. All programs are based on Drew’s renowned commitment to faculty-student mentorship, opportunities for out-of-the-classroom experiential learning, and facilitating a robust intellectual and global community, with many programs offered in hybrid or fully online modalities. To enrich education through diversity, Drew University is an Equal Opportunity Employer. Following federal and state requirements, a candidate must provide proof of eligibility to work in the United States if selected for hire. These positions are subject to a background check.

Director83 days ago

Role Description Drew University is seeking a Business Director. This is a full-time, exempt position, reporting to the Vice President for University Advancement. The Business Director serves as the operational and financial backbone of the University Advancement division. This senior individual-contributor role combines strategic fiscal stewardship, high-level operational coordination, and Board-level engagement. This position also includes dedicated executive support to the Vice President to ensure the division functions at peak efficiency. The Business Director manages the full financial portfolio of the Advancement division, oversees business operations for the Concert Hall, and serves as the primary operational partner to the Vice President. In this capacity, the Business Director translates institutional priorities into action - often without direct supervision and with significant latitude to make time-sensitive decisions on behalf of the division, ensuring seamless coordination across internal and external stakeholders. This position is remote with occasional travel to campus for meetings and/or events. Qualifications - Bachelor’s degree or equivalent experience. - 6–10 years of progressive experience in departmental administration, preferably in higher education, with demonstrated financial/operational management responsibilities. - Self-starter with entrepreneurial spirit and the ability to act decisively with a high degree of autonomy and make consequential decisions with limited oversight in a fast-moving and dynamic environment. - Highly resourceful, with the ability to formulate and implement creative solutions independently. - Proven experience managing budgets, financial reporting, and fiscal operations in a higher education or nonprofit environment. - Strong interpersonal skills and the ability to interact effectively with a diverse population of administrators, trustees, donors, and staff. - Demonstrated ability to draft and edit professional communications, proposals, and executive presentations for senior and Board-level audiences. - Exceptional organizational skills and meticulous attention to detail. - Proven track record of handling highly confidential and sensitive information and situations with discretion. - Experience working with Google G Suite and Microsoft Office products with familiarity with CRM systems. Direct experience with Banner and/or Raiser’s Edge is a plus. - Experience supporting senior executives in a fast-paced, high-stakes environment with competing priorities. - Ability and willingness to work outside of standard business hours, including evenings and weekends, as required for events and Board meetings. Requirements - Builds and manages comprehensive strategic fiscal planning and budgeting for the University Advancement division, including coordination and preparation of the Annual Operating budgets for Advancement, Donor-Funded Events & Programming, The Concert Hall, and Campus Venue Rentals. - Independently evaluates financial risks and recommends course-corrections to the Vice President, exercising significant judgment in prioritizing competing fiscal needs across the division. - Oversees all contract and standard operating procedure reviews for all the above areas and is the liaison between the University and Advancement vendors. - Supervises the departmental Office Manager and oversees their work that includes - but is not limited to - vendor requisitions, purchase orders, check requests, and travel/purchase card reconciliations. - Maintains detailed budget files and financial records; monitors departmental expenditure; and tracks budget variances. - Serves as the division's primary liaison to campus Finance, Financial Aid, Student Accounts, Human Resources, and Legal. - Provides ad-hoc financial analysis and decision-support materials to the Vice President and senior leadership. - As part of the overall departmental fiscal management, oversees all business and financial operations for the Concert Hall, including contract review, vendor management, revenue tracking, and expense reconciliation. - Partners with Concert Hall leadership to develop and monitor annual operating budgets, ensuring alignment with divisional financial goals. - Ensures compliance with university financial policies in all Concert Hall transactions and agreements. - Designs and oversees the planning, coordination, and execution of large donor-funded annual events - such as the multi-engagement Drew Forum, The Kean Visiting Professorship, and The Karpati Lecture - ensuring programming reflects donor intent and institutional priorities. - Collaborates with Advancement leadership, major donors, and campus partners, to develop event concepts, manage timelines, and deliver high-quality experiences for donors, stakeholders, and audiences. - Tracks event budgets and expenditures against donor-designated funds, ensuring compliance with gift restrictions and University financial policies. - Produces post-event reports and stewardship materials that document outcomes and communicate impact to donors and stakeholders. - Staff the Board of Trustees Advancement Committee, the Committee on Trustees, and the Finance and Investment committees and organizing meetings, managing minutes and agendas, and preparing presentations and materials for the committees and their sub-committees. - Develops polished PowerPoint/Google Slides presentations for senior leadership and Board audiences. - Exercises independent judgment in determining when matters require Vice President escalation versus direct resolution, serving as a decision-making proxy on routine and recurring operational issues. - Serves as a conduit between the Vice President and internal and external stakeholders, facilitating communication and ensuring timely responses on key institutional matters. - Independently creates and maintains departmental policies, protocols, and administrative records—including confidential personnel files. - Manages the Vice President’s calendar, appointments, and travel arrangements with a high degree of judgment and discretion, proactively and independently resolving scheduling conflicts and anticipating needs. Benefits - To apply for this position, please submit the following materials: - Cover letter - Resume Company Description Drew University, a Phi Beta Kappa liberal arts university, includes the College of Liberal Arts, Drew Theological School, and the Caspersen School of Graduate Studies. Drew is located on a beautiful, wooded campus in Madison, New Jersey, a thriving small town close to New York City. Drew’s one-of-a-kind, leading-edge path to an undergraduate degree, Launch, ensures that every student graduates with a purpose, sought-after transferable skills, a network of mentors, and an experience-based résumé—guaranteed. Drew’s unique, immersive learning experiences include professionally mentored scientific research in RISE and DSSI, volunteer and community-based opportunities through the Center for Civic Engagement, making industry connections in seven semesters in New York City, and exploring the world through eye-opening international study abroad trips. Drew University’s two graduate schools, Drew Theological School and the Caspersen School of Graduate Studies, confer 10 master’s and four doctoral degrees. Numerous certificate programs are also available. All programs are based on Drew’s renowned commitment to faculty-student mentorship, opportunities for out-of-the-classroom experiential learning, and facilitating a robust intellectual and global community, with many programs offered in hybrid or fully online modalities. To enrich education through diversity, Drew University is an Equal Opportunity Employer. Following federal and state requirements, a candidate must provide proof of eligibility to work in the United States if selected for hire. These positions are subject to a background check.

United States
$88K - $93.5K / year
Job Closed
WaterConnect logo

Regional Director – Central and South Asia

WaterConnect

For infrastructure developers, technology providers, and investors seeking a partner in growth.

Director83 days ago
Full TimeRemoteTeam 1-10H1B No Sponsor

**Job** **Responsibilities** Regional Business Development - pipeline development - Identify and develop a pipeline of bankable WSS infrastructure opportunities suitable for private investment - Develop and maintain relationships with various partners in the sector: private developers, technology providers, utilities, and investors Regional portfolio growth - Screen and due diligence potential partners and opportunities - Prepare due diligence reports and present to approval committee - Negotiate term sheets and development agreements, in partnership with WaterConnect colleagues Regional project development execution - Support WaterConnect project management team to oversee project development - Support engagement and management of third-party service providers and vendors - Engage with co-developers, offtakers, investors, regulators Regional portfolio monitoring and management - Ensure accurate, timely reporting on project progress, risks and related KPIs - Local stakeholder management - Identify opportunities to improve WSS infrastructure policy and regulations to promote private sector participation, private investment, environmental impact Cross-functional support - Contribute to strategic projects of WaterConnect and the larger group of companies, as needed from time to time

India