Sr. Manager, GMP Quality

About the role

This role is for 40 hours per week and is a remote position. The position requires serving as the QA representative on cross-functional project teams, interfacing with Quality and Production departments at domestic and international contract manufacturing organizations, as well as within SMPA’s Quality, Supply Chain, CMC, and Commercial Manufacturing departments.

Responsibilities

• Conduct product release activities for clinical and commercial drug substances and drug products, including review and approval of Master Batch Records, Executed Batch Records, release and stability testing documentation, and batch disposition, ensuring timely completion to maintain product supply while upholding quality and safety standards.
• Partner with CMC and Commercial Manufacturing to conduct technical transfers and validation of new or existing processes and products to domestic and international contract manufacturing organizations.
• Support commercial validation activities by reviewing validation protocols and reports.
• Ensure compliance to existing procedures and support continuous improvement by identifying opportunities for efficiency gains through SOP and compliance standard revisions.
• Author, review, and approve standard procedures and electronic systems as needed.
• Lead, author, review, and/or approve CMO Quality Events, Investigations, CAPA, Change Controls, and Complaints, as well as initiate entries in SMPA’s eQMS as needed; this may require timely interface with domestic and international suppliers.
• Serve as Person-in-the-Plant as needed.
• Author relevant sections of Annual Product Reviews by compiling appropriate data and metrics and making appropriate recommendations.
• Perform other duties as assigned.

Skills

• Advanced knowledge of GMP manufacturing and/or market release of pharmaceutical dosage forms and/or combination products.
• Experience managing external CMOs, contract laboratories, and third-party logistics suppliers.
• Experience reviewing and approving master and executed batch records and performing final disposition of drug substances and products.
• Experience managing quality events (investigations, CAPA, and change control), and working knowledge of formal risk management tools and assessments.
• Ability to evaluate and assess technically complex quality events and document these events with excellent technical writing skills.
• Experience evolving GMP-related quality systems, policies, and procedures to ensure compliance with evolving standards and improving workflow efficiency.
• Strong ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations.
• Excellent verbal and written communication skills, including the ability to interact effectively with senior management, partners, and project core team members.
• Self-motivated, flexible, and able to prioritize work and handle multiple assignments in a fast-paced environment while maintaining high quality and compliance standards.