Manager, Quality Assurance Compliance
Core
Manage the compliance, audit, training, and operations team for an internal fill-finish site, ensuring adherence to industry standards and regulatory requirements.
Role type
Manager, Quality Assurance Compliance
Builds
Internal fill-finish site operations and compliance frameworks
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
client delivery
Required skills
Quality compliance management, audit readiness and execution, lifecycle management of quality records (Notices of Event, Change Controls, CAPAs), cross-site continuous improvement, governance and policy shaping, regulatory trend analysis
Preferred skills
Drug product manufacturing experience, fill finish operations experience
Technologies
None explicitly stated
Responsibilities
Lead and develop the QA compliance team by setting work plans, prioritizing tasks, coaching performance, and managing hiring/separations; Partner with senior leadership to communicate compliance status and provide actionable project reporting; Oversee the lifecycle of quality records including tracking, reporting, and driving closure; Drive audit readiness and execution by aligning practices with requirements and supporting internal/regulatory audits; Promote cross-site continuous improvement by identifying gaps and sharing best practices; Shape governance by influencing local and global policies to align with industry standards; Stay current on industry trends and translate insights into operational improvements
Seniority
Manager level, 7+ years of relevant experience
