Manager, CQV Quality Control

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.
• Coverage 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.

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