Quality Control Manager
: Job Details :

Job Description Quality Assurance Manager

The Manager, Quality Assurance manages the PPU support unit services of the QA department and oversees setting accurate schedules and resources. The role involves performing Quality Assurance activities with minimal supervision, supporting corporate Quality Systems and client procedures, including document management, batch record review, QC data, SOPs, material and final product releases, and assisting Quality management with departmental needs.

The ideal candidate exercises judgment within generally defined practices and policies, implements ongoing quality improvement processes with interdepartmental teams, and develops quality assurance metrics for performance enhancement. The manager anticipates program release issues, takes corrective actions, and collaborates with project managers on schedules and resource allocation for QA projects, software deployment, customer integration, and validation activities.

The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III), support manufacturing processes, ensure the safe release of cellular products per HCATs and client requirements, and promote compliance with CGMP and GTP regulations and SOPs. Responsibilities include establishing documentation policies, authoring and reviewing SOPs, managing batch records and deviations, controlling lot numbers, overseeing nonconformance dispositions, investigating deviations, and implementing corrective actions.

The role involves interfacing with suppliers and production personnel, monitoring corrective actions, supporting investigations, providing quality metrics, hosting client audits, and training staff on QSR, ISO, and company quality systems. The manager will also mentor the QA team, lead the implementation of Quality Agreements, and maintain compliance.

REQUIREMENTS

• BS Degree in biological sciences or equivalent.
• Minimum 5-10 years of experience in the pharmaceutical or biologics industry.
• Understanding of cGMPs and GLPs.
• Knowledge of laboratory operations, equipment, validation, and aseptic processing.
• Proficiency in Microsoft Office, Visio, Microsoft Project, and Excel.
• Excellent organizational, communication, and team skills.
• Ability to travel and adapt to evolving responsibilities.

Please note this job description is not exhaustive and duties may change as needed.