Associate Director, Quality Assurance Operations

Associate Director, Quality Assurance Operations

Location: New Haven, CT (Northeast Preferred). This position is remote but may require up to 20% travel to oversee/audit contract manufacturing organizations and meet with internal teams at the New Haven HQ.

Position Summary: The Quality Team creates a breakthrough future as a value-added business partner by enabling innovation, productivity, and continuous improvement while ensuring adherence to applicable regulations and maintaining a focus on patient safety. The ideal candidate will be an experienced Quality professional and subject‑matter expert on Biological GMPs for products in all phases of development through commercialization. The candidate will act as a resource and provide guidance to the Quality department as well as partnering with Manufacturing, Supply Chain, and Process Development counterparts to incorporate value-added, fit-for-purpose, quality principles into the process.

This is a hands‑on position where the successful candidate works collaboratively as a business partner to ensure alignment on priorities and incorporates a science-based risk management approach to actions and deliverables. Quality CMC oversight of external vendors is a main of. This position will report to the VP of CMC Regulatory and Quality.

• Review and approve relevant GMP documents for compliance with Invivyd’s Quality Management Systems and Health Agency regulations, including specifications, batch manufacturing records, stability protocols/reports, methods, and process validation documents.
• Work collaboratively with Manufacturing and Supply Chain counterparts to facilitate timely and effective resolution of process deviations, investigations, CAPAs, and batch record reviews, and to facilitate timely batch release/disposition to meet clinical and/or commercial needs.
• Participate in audits of GMP service providers according to appropriate Invivyd Quality Management System and regulatory requirements.
• Conduct Quality Management Review meetings with Executive Management to review the suitability and effectiveness of the Quality Management System.
• Create and revise SOPs as appropriate, including keeping up with SOP Periodic Review requirements.
• Upgrade Vendor Management Program by authoring/revising QA procedures as appropriate.
• Develop internal and external audit schedules and execute per audit plan.
• Apply Risk Management principles to qualification and oversight of external service providers.
• Participate in and manage regulatory inspections, including presenting and defending the GMP Vendor Management Program in regulatory inspections.
• Maintain current knowledge of GMP regulations and guidances, in particular regulatory intelligence regarding vendor management expectations.
• Provide ongoing guidance and ensure compliance with established systems, processes, and procedures.
• Assist in the development, implementation, and maintenance GMP training and compliance programs for all company personnel involved in GMP activities.
• Partner with stakeholders on maintenance and implementation of other training across the organization (i.e., Clinical Quality Assurance, IT, HR, Finance, Corporate Compliance, Medical Affairs) to ensure full compliance.

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A bachelor’s degree in a scientific discipline or biotechnology field.
• Minimum of ten years of experience in the pharmaceutical industry with a minimum of five years in Quality Assurance, or a masters/doctorate degree with commensurate level of experience.
• Strong knowledge and experience with ICH, USP, 21 CFR 210, 21 CFR 211, 21 CFR 600, and EMA regulations including vendor management.
• Expertise in applying GMPs for Development, Clinical Supplies, and Commercial Drug Substance and Drug Products.
• Extensive hands‑on experience in:
  • Biologics manufacturing and Quality Assurance (experience with launch and commercialization of a biologics product is desired).
  • Vendor Management (qualification audits, quality agreements, relationship building) and presenting and defending Vendor Management program during regulatory inspections.
  • Exception Management (deviation investigations, CAPA development, Change Control).
  • Product…