Associate Director, GMP QA Operations

Role Summary
The Associate Director, QA Operations serves as the QA technical lead for external manufacturing and testing project teams, ensuring development, implementation, and continuous improvement of Quality Systems and GMP-supporting procedures, policies, and metrics. Leads QA operations, identifies/mitigates compliance risks, and serves as SME for complex quality issues and escalations.

Primary Responsibilities
- Serve as QA lead for external manufacturing/testing teams; provide technical guidance/quality oversight
- Represent QA Operations with CMOs and external partners; ensure alignment of contract activities with regulatory requirements and best practices
- Participate in CMO Quality Agreement review/management
- Oversee release activities for DSI/DS/DP (batch record review and disposition)
- Lead/support investigations for significant quality issues; drive RCA and CAPA (tracking and effectiveness verification)
- Support change management; provide input into specifications, stability protocols, and product labeling
- Support regulatory submissions (e.g., INDs)
- Develop/maintain GMP Quality Systems and KPIs; improve batch record review processes; manage CMO documentation
- Participate in domestic/international CMO audits; support internal audits; collaborate cross-functionally; provide QA training/mentorship; communicate quality risks

Education & Skills Requirements
- BS in Engineering/Science (or relevant); MS preferred
- 8+ years in related cGMP environment; 5+ years in Quality Assurance (preferably with CMO/CDMO oversight)
- Knowledge of international regulations (FDA & EMA)
- Experience with GXP QA systems (documentation/records, change control, deviations, investigations, training, CAPA)
- Strong judgment, communication, organization, and collaborative problem-solving
- Proficiency: MS Office; SmartSheet, Veeva a plus

MA Pay Range
$175,000 - $200,000 USD