Job Summary
The Manager, CQV Quality Control is responsible for the strategic and operational leadership of QC CQV (Commissioning, Qualification, and Validation) activities in support of clinical and commercial biologics manufacturing. This role oversees laboratory systems, analytical instrumentation lifecycle management, computerized systems, and CQV compliance to ensure reliable, compliant, and efficient QC operations.
The position provides leadership and direction to the QC CQV team, ensuring execution of qualification, calibration, maintenance, and system validation activities in accordance with cGMP requirements. The Manager serves as a key partner to Quality Assurance, Manufacturing, Facilities & Engineering, IT, and client teams to support inspection readiness, continuous improvement, and high-quality delivery
Job Responsibilities:
- Provide leadership and oversight for daily QC CQV operations to ensure compliance with cGMP, regulatory requirements, and internal procedures.
- Accountable for instrument and system lifecycle management, including qualification, calibration, preventive maintenance, and periodic review.
- Ensure the execution and review of calibration plans, preventive maintenance (PM), and periodic review (PRE) activities for QC instruments and equipment.
- Oversee qualification of analytical instruments, equipment, and systems, ensuring documentation meets regulatory and internal quality standards.
- Lead and oversee computerized system validation activities for QC systems and analytical instrument software (e.g., Empower, 32Karat, SoloVPE, EndoScan‑V).
- Ensure all systems are maintained in a validated state, including user access management, audit trail review, system configuration, and data integrity compliance.
- Ensure compliance with data integrity principles (ALCOA+) and applicable regulations (e.g., 21 CFR Part 11, EU Annex 11).
People & Resource Management
- Lead, supervise, and develop the QC CQV team, including performance management, coaching, and career development.
- Ensure appropriate training, qualification, and competency of staff to support CQV and system management activities
- Allocate resources and manage workload to ensure timely execution of CQV deliverables.
- Foster a culture of quality, accountability, collaboration, and continuous improvement.
Laboratory Systems & Equipment Management
- Oversee vendor coordination and service activities for instrument maintenance, calibration, and repair in collaboration with Facilities & Engineering (F&E).
- Ensure effective lifecycle management of analytical instruments and laboratory systems, including installation, qualification, operation, and retirement.
- Oversee system performance, reliability, and compliance through routine monitoring and periodic review processes.
- Manage QC fixed assets in alignment with company financial and asset management policies, including asset tracking, capitalization support, lifecycle status, and decommissioning activities.
- Ensure accurate documentation and control of QC assets within asset management systems, and support periodic asset verification, audits, and reconciliation activities.
- Partner with Finance, Procurement, and Facilities to support asset acquisition, transfer, and disposal processes in compliance with company procedures.
Computerized Systems & Lab Admin Oversight
- Provide oversight for QC computerized systems (e.g., LIMS, Empower, LES, CisPro systems), ensuring compliant design, implementation, validation, and routine operation.
- Lead and support system enhancements, optimization initiatives, and cross-site alignment activities.
- Ensure proper configuration, maintenance, and continuous improvement of QC systems to meet operational needs.
- Oversee data integrity self-inspections and ensure timely resolution of identified gaps.
- Coordinate with IT and validation teams on system qualification, upgrades, and issue resolution.
Quality Systems & Continuous Improvement
- Lead and support QC system improvement initiatives, including integration of WuXi Business System (WBS) tools (e.g., GEMBA, Tier boards).
- Drive continuous improvement initiatives to enhance efficiency, compliance, and right-first-time execution.
- Monitor and ensure adherence to QC compliance metrics aligned with QA Quality Council and Quality Management Review requirements.
- Support and review QC SOPs and procedural updates related to CQV and system management.
Audit & Inspection Readiness
- Ensure QC CQV readiness for internal audits, client audits, and regulatory inspections.
- Participate in inspections and audits as SME for CQV and computerized systems.
- Support responses to audit observations, regulatory inquiries, and CAPA implementation.
Cross-Functional & Client Support
- Serve as a key QC CQV representative in cross-functional teams including QA, Manufacturing, MSAT, IT, and Facilities.
- Collaborate with stakeholders to ensure alignment on system qualification, maintenance, and compliance requirements.
- Support client interactions related to CQV scope, including participation in discussions, audits, and technical clarifications as needed.
Additional Responsibilities
- Perform other duties as assigned based on business needs and organizational priorities.
Qualifications
- Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or a related field with 9–11 years of experience
- Master’s degree with 7–9 years of experience
- PhD with 4–6 years of relevant experience
- Extensive experience in QC laboratories and cGMP environments
- Strong knowledge of analytical instrument qualification, calibration, and maintenance (e.g., UPLC, HPLC, CE, icIEF)
- Demonstrated experience with computerized systems and regulatory requirements (21 CFR Part 11, EU Annex 11)
- Strong understanding of data integrity principles (ALCOA+)
- Proven experience in deviation management, change control, and audit support
Preferred Capabilities
- Demonstrated people leadership and team management experience in a QC or biopharmaceutical environment
- Experience overseeing laboratory systems such as LIMS, Empower, LES, and inventory systems
- Strong understanding of CQV lifecycle and computerized system validation
- Experience driving continuous improvement and operational excellence initiatives
- Ability to manage multiple priorities in a fast-paced, client-facing environment
- Strong communication and stakeholder management skills
