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The Quality Assurance Senior Manager will lead and oversee quality operations supporting GMP manufacturing activities. This role is responsible for driving compliance, managing complex quality investigations, leading cross-functional teams, and ensuring quality systems are effective, compliant, and continuously improving. The position requires strong leadership, deep GMP expertise, and the ability to make sound quality decisions in a fast-paced environment.
Key Responsibilities
Lead GMP quality operations supporting manufacturing, supply chain, and external partners
Serve as a Quality representative for cross-functional and cross-site initiatives
Lead and approve deviation investigations, Root Cause Analysis (RCA), and CAPA activities
Ensure timely, thorough, and compliant execution of investigations and corrective actions
Oversee and enforce quality agreements with CMOs and suppliers
Review, approve, and manage GMP documentation including:
SOPs and work instructions
Specifications and methods
Validation protocols and reports
Ensure compliance with applicable GMP regulations and internal quality standards
Utilize electronic document management and quality systems to manage investigations, CAPAs, and documentation
Lead complex projects, facilitate meetings, and drive tasks to completion using structured project management approaches
Identify quality risks and proactively implement mitigation strategies
Support audits, inspections, and regulatory interactions as a Quality subject matter expert
Partner cross-functionally with Manufacturing, Engineering, Supply Chain, Regulatory, and external stakeholders
Leadership & People Management
Lead, mentor, and develop Quality team members
Provide technical guidance and coaching on quality systems and GMP expectations
Build strong, collaborative teams and foster a culture of quality and accountability
Evaluate team performance and support professional growth and development
Effectively communicate quality expectations across diverse technical and non-technical audiences
Qualifications & Experience
Bachelor's degree required
Minimum of 6 years of experience supporting GMP manufacturing environments
Strong hands-on experience with:
GMP investigations, RCA, and CAPA management
Investigation and CAPA approvals
Electronic Quality Management Systems (eQMS), including tools such as QDoccs, TrackWise, and Veeva
Proven experience authoring, reviewing, and enforcing quality agreements with CMOs and suppliers
Demonstrated ability to evaluate complex quality issues and make sound, compliant decisions
Strong project management skills with experience leading cross-functional teams
Ability to independently represent the Quality function in internal and external forums
Excellent written and verbal communication skills
Ability to thrive in a fast-paced, highly regulated environment