Sr. Manager Quality Assurance

Responsibilities

• Ensure systems under QA management are functioning and being followed
• Oversight of QA Department with specific responsibilities of monitoring of manufacturing processes, Process Control, and Investigations
• Provide technical oversight and mentorship to Process Quality Engineers, ensuring balanced workloads, development opportunities, and alignment with department priorities
• Lead complex deviation investigations, root cause analyses, and quality assessments with high visibility to leadership
• Lead cross-functional teams in identifying, assessing, and mitigating product and process failures to maintain compliance, efficiency, and quality
• Responsible for review and QA approval of all implementation and changes of GMP Systems (Protocols, Deviations, OOS, Change Control and CAPA)
• Participate in Customer Audits, Supplier Audits and Quality and Regulatory Audits
• Manage, supervise, mentor Process Control Supervisors, Shift Leads and Quality Engineers
• Cook routine team meetings to develop, mitigate potential gaps, review trends and steer process improvements
• Oversee training and development of team
• Perform employee counseling and facilitate conflict resolution
• Champion continuous improvement initiatives and foster a strong cGMP compliance culture across operations

Qualifications

• Four-year college degree in Engineering, Pharmacy, Chemistry, Biology or related field. MS is a plus but not required
• 7 to 10 years quality operations experience in the pharmaceutical industry
• Demonstrated expertise in leading quality operations team and process quality control
• Thorough knowledge of cGMP guidelines
• Thorough knowledge of Pharmaceutical processes
• Understand basic principles of formulation, filling, and packaging
• Experience in managing employee performance
• Strong interpersonal and group skills with the ability to motivate and direct others
• Strong communication skills, verbal and written