Senior Manager, Quality Control Operations

Position Summary:

ultrafocused - Work together to fearlessly uncover new possibilities

Reporting to the Director, Quality Control Operations, the Senior Manager, QC Operations and Stability will perform quality control functions supporting drug substance, drug product and cell banks. This individual with collaborate with cross functional stakeholders and externally with contract manufacturing facilities.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

• Evaluate product stability data to establish and extend product shelf-life.

• Assure ongoing readiness for regulatory inspection; participate in audits and inspections.

• Create and improve procedures.

• Support Regulatory submissions (e.g, INDs, BLAs), coordinate data requests, compilation and management of externally generated data

• Ensures appropriate data integrity controls/ALCOA/data integrity issues for system requirements.

• Generation of Certificate of Analysis

• Serve as a technical lead for management of Quality Records: Global application of root cause, deviations, impact assessments, complex investigations in collaboration with other departments.

• Provide hands-on leadership for the QC Operations oversight of the group, data review, schedule and training.

• Provide oversight and support to contingent staff on site

Requirements:

• BS in Biology, Biochemistry, Chemistry or equivalent are of study/discipline

• 7+ years of GMP experience in Pharmaceutical Industry

• Experience in data management, LIMS experience preferred

• Organized and skilled in managing multiple responsibilities, priorities, tasks and projects simultaneously

• Strong interpersonal skills that include negotiation, active listening, and relationship management

• Comfortable with interfacing effectively across all levels and organizations

• Independently motivated and detail-oriented with good critical thinking, problem-solving ability, and analytical skills #LI-CS1 #LI-Onsite