Senior Manager – Quality Assurance

We’re seeking a Senior Quality Assurance Manager to assist in developing phase-appropriate Quality operation to support manufacturing for global clinical trials.  The Senior Manager, Quality Assurance, will provide leadership and direction for the QA Systems and Operations. This person will be responsible for Quality oversight of early and late phase GMP manufacturing activities both internally and with external CMOs for drug substance and drug product.

The Senior manager will provide guidance and mentorship to a growing team of QA professionals and work closely with various teams and line functions including manufacturing, supply chain, quality control, facilities, process development, and regulatory to ensure quality GMP standards, compliance with global regulations, and support of regulatory filings.

Position Responsibilities:

• Manage and mentor QA team members
• Develop and maintain SOPs and QA operations for oversight of the manufacturing, testing and release of raw materials, drug substance and drug product
• Manage Quality Systems such as CAPAs, change control, deviations, etc.
• Review and approve qualifications and validations
• Provide direction and support of investigations
• Supervise disposition activities for both clinical drug substance and drug product
• Oversee quality metrics program

Preferred Skills:

• Expert in GMP requirements for multiple jurisdictions, including US and EU
• Strong investigational and change management skills
• Ability to effectively communicate sound Quality advice cross-functionally, based on regulations and business needs
• Ability to flexibly adapt to changing business needs and meet timelines within a fast-paced environment
• Strong people manager with ability to achieve results through principle-based leadership.

Education / Experience:

• BS in a scientific discipline; an advanced degree preferred
• 8+ years of leadership experience within Pharmaceutical Quality
• Experience in sterile injectables in clinical development is highly preferred but by no means required