Quality Manager

Job Title:

Quality Manager

Job Description

The Quality Manager provides comprehensive oversight of Quality Control (QC) testing activities and contract testing laboratories, ensuring robust analytical methods, compliant product release, and alignment with global regulatory expectations. This role leads the governance of QC documentation, stability programs, and quality systems, while partnering closely with internal teams and external CDMOs and CTLs to maintain high standards of product quality and patient-focused outcomes.

Responsibilities

* Provide end-to-end oversight of contract testing laboratories (CTLs) and QC testing activities, ensuring all work complies with applicable GxP and GMP requirements.

* Oversee the development, review, and approval of Justification of Specifications (JOS), product specifications, and Certificates of Analysis (CoA) to support compliant product release.

* Ensure comprehensive lifecycle management and validation of analytical methods at CTLs, including proper implementation, maintenance, and change control.

* Lead oversight of stability and shelf-life programs, monitoring expiry dating and stability trends to maintain product quality throughout the product lifecycle.

* Perform QA review of QC test data and contribute to batch disposition decisions for starting materials, drug substance, and drug product in collaboration with cross-functional teams.

* Coordinate batch disposition activities across internal groups and external partners to ensure timely and compliant product release.

* Lead and support investigations and resolution of QC quality events, including deviations, Change Control Records (CCR), and Corrective and Preventive Actions (CAPA) across internal departments, CDMOs, and CTLs.

* Manage QC documentation and quality processes for both internal and external partners, including oversight and maintenance of Quality Technical Agreements with CTLs.

* Define, implement, and maintain the CTL oversight model, including risk-based oversight strategies, monitoring of key performance indicators, and clear escalation pathways.

* Support the implementation of EU in-country testing strategies in collaboration with relevant stakeholders and external partners.

* Provide quality input and documentation support for regulatory filings, ensuring compliance with global standards and facilitating successful submissions.

* Participate in internal and external cross-functional meetings, providing quality guidance, risk mitigation support, and recommendations for path-forward decisions.

* Contribute to continuous improvement initiatives within the Quality Assurance department and across other functions, identifying opportunities to enhance quality systems, processes, and efficiency.

* Utilize and help optimize electronic quality management systems and other digital tools, such as ZenQMS, Veeva, and Trackwise, to manage deviations, CAPAs, change controls, and batch record reviews.

* Support technology transfer, process validation, and analytical method development activities from a QA/QC perspective, ensuring appropriate quality oversight.

* Perform batch record review and ensure all quality documentation is complete, accurate, and audit-ready.

* Carry out additional quality-related duties as assigned based on evolving company and departmental needs.

Essential Skills

* Minimum of 8 years of experience in a quality assurance department within the biotech or pharmaceutical industry.

* Strong, hands-on experience in GxP QC and analytical roles in addition to QA responsibilities.

* Deep understanding of GMP requirements as they relate to QC and analytical testing.

* Proven experience working with contract testing laboratories (CTLs) and CDMOs.

* Demonstrated expertise in Quality Control and QC analytical activities, including analytical method development and validation.

* Practical experience with batch record review, QA review of test data, and batch disposition for starting materials, drug substance, and drug product.

* Strong knowledge of quality systems and electronic quality management systems, with direct experience using at least one eQMS platform.

* Experience managing deviations, CAPAs,…