The Sr. Manager Quality Assurance supports oversight of manufacturing process monitoring, process control, and investigations. These functions are responsible for monitoring and reporting the quality status of commercial and development products, as well as ensuring investigations comply with GMP and regulatory requirements. This oversight supports pharmaceutical manufacturing and distribution across all stages at TRC. The Sr. Manager also partners with the Director of Quality Assurance to ensure Ritedose maintains well-defined, effective quality systems that align with current regulatory expectations and guidance.
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
- Coordinate 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.
- 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
Skills Required
- Bachelor’s degree in Engineering, Pharmacy, Chemistry, Biology, or related field
- Master’s degree (MS)
- 7 to 10 years quality operations experience in the pharmaceutical industry
- Demonstrated expertise leading quality operations teams and process quality control
- Thorough knowledge of cGMP guidelines
- Thorough knowledge of pharmaceutical processes
- Understanding of formulation, filling, and packaging principles
- Experience managing employee performance
- Strong interpersonal and group leadership skills
- Strong verbal and written communication skills
What We Do
The Ritedose Corporation is a leading pharmaceutical contract development and manufacturing organization (CDMO) specializing in sterile Blow-Fill-Seal (BFS) technology for branded and generic medications.
