Senior Director leading global product strategy for Progyny’s women’s health solutions. Define product direction and drive innovation across international markets.
About the role
- Global C&Q Director leading best practices in commissioning and qualification for GSK. Collaborating with teams to ensure compliance and drive superior performance.
Responsibilities
- Lead and manage the consistent deployment of best in class capability and capacity of commissioning and qualification activities
- Ensure all project equipment, systems, and processes consistently meet regulatory and company standards
- Collaborate with cross-functional teams including engineering, quality assurance, manufacturing, and regulatory affairs
- Drive towards best in class practices leveraging digital and AI
- Support development and implement global C&Q strategies and policies
- Provide leadership and direction to regional/project C&Q teams
- Oversee the planning, execution, and completion of C&Q projects across multiple projects
- Provide technical guidance and support for C&Q activities
- Ensure compliance with GSK’s quality management system and applicable regulatory requirements
- Support recruitment, training, and mentoring of C&Q staff
- Build and maintain strong relationships with internal and external stakeholders
Requirements
- Engineering degree (Mechanical, Electrical, Chemical, Civil/Structural)
- Extensive project validation experience
- Proven experience in leading validation teams in the pharmaceutical or biotech industry
- Proven track record of successfully leading and managing global C&Q projects
- Proven track record of regulatory authority audit participation and defence of validation project plans and results
- In-depth knowledge of regulatory requirements and industry standards (e.g., GMP, GAMP, ICH guidelines)
- Experience in biopharm specific unit operations and platforms – drug substance/primary, DP/sterile filling, and packaging
- Strong project management skills, with experience in managing complex, multi-site projects
- Deep and broad understanding of the capital project lifecycle – design, construction, commissioning, qualification, to operation.
- Strong stakeholder management and influencing capabilities
Benefits
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Director of Grants managing federal grant strategies for higher education clients. Collaborating with leadership and delivering results within fixed deadlines in a consulting firm.
Managing Director overseeing audit and advisory services for middle market businesses. Leading business development, client relationships, and operational management.
Director leading policy and research efforts for Christian organization tackling global hunger issues. Overseeing advocacy, research, and compliance for Bread for the World in the D.C. area.
Director of Admissions overseeing intake and admissions for Center for Healing at Greenwich House. Ensuring compliance, supervising staff, and conducting interviews within a mission - driven organization.
Director of Internal Audit at AdaptHealth overseeing audit activities and compliance in healthcare. Responsible for leading internal audit strategy and continuous improvement in risk management.
Director/Senior Manager in Learning & Development with Deloitte. Developing innovative learning programmes and strategies for workforce transformation projects.
Director of BCM and Incident Management managing crisis response and continuity strategies at Manulife. Ensuring uninterrupted operations by mitigating various risks during disruptions.
Director of Transaction Advisory Services at Armanino providing financial advisory through due diligence and collaborative engagements. Leading financial analysis for private equity deals with a strong emphasis on client management.
Director of Games leading portfolio development and innovation for Interactive Instant Win and Draw - Based Games. Collaborating with digital leadership to enhance performance for good causes within Allwyn UK.