Senior Quality Assurance Manager

RBW are partnered with a CDMO focused Cell Line Development with over 20 years industry experience. They are looking to expand their QA departments as they continue to grow their teams across the East Coast and develop their client offering to include both Clinical and Commercial production.

They are looking for an ambitious QA Manager to lead a team and liaise with Program Management to ensure effective communication with the clients, prioritising high quality.

Position Requirements:

• Oversee the Deviation, CAPA, and Complaint Quality systems.
• Monitor, analyze, and report quality metrics.
• Conduct compliant investigations, and endorse investigations and corrective/preventative actions.
• Create and/or enhance training materials for Quality Systems, including Deviation/CAPA system and batch record review.
• Train and certify QA personnel.
• Offer coaching and mentorship to QA specialists and direct reports.
• Assist in Client Audits and Regulatory Inspections.
• Collaborate with Program Management, Technical Operations, and Manufacturing teams.
• Engage with clients regarding quality-related issues as necessary.

Experience:

• A Bachelor’s degree is required.
• Over 10 years of experience in QA or a cGMP-regulated environment.
• Proven experience in QA support for Quality Systems, including Deviations, CAPAs, and Complaints.
• At least 4 years of supervisory experience.
• Strong interpersonal skills, team-oriented, detail-focused, and adept at problem-solving.
• Comprehensive knowledge of FDA, EU, and ROW cGMP regulations is essential.