Quality Assurance Manager (Bioanalytical)

Introduction to Ardena

As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—united by the mission to help biopharma innovators navigate drug development with precision, quality, and speed, bringing their molecules from discovery to the clinic and market. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support.

With a rapidly growing international footprint, Ardena is home to over 750 professionals across six strategic locations—Belgium (Ghent), the Netherlands (Oss and Assen), Sweden (Södertälje), Spain (Pamplona), and Somerset, New Jersey (the US). Our open and transparent culture is built on collaboration, ownership, and innovation, guided by our We CARE values. We foster a communicative environment where mutual respect, accountability, and excellence empower our team.

We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Whether you’re an experienced expert or just starting out, Ardena provides a dynamic workplace where you can contribute to meaningful drug development projects, expand your knowledge, and be part of a global team committed to making a difference. As an international organization, we help you navigate a career path that expands your possibilities beyond borders, opening doors to personal and professional growth without limits. Your potential to grow is limitless with us.

If you are ready to take on new opportunities, work alongside industry experts, and contribute to the future of medicine, Ardena is the place for you.
 

For the Ardena Business Unit based in Somerset (US), we are looking for a Quality Assurance Manager (Bioanalytical)

WHAT YOU WILL WORK ON

YOUR ROLE

The Manager, Quality Assurance Bioanalytical provides oversight of the QA team and execution of audits, quality system improvements, and compliance-related activities.

The manager ensures GxP compliance with operational GLP and GCP responsibilities, operates within budgets, and supervises bioanalytical QA staff directly. Responsibilities include hiring, training, goal setting, and performance evaluation. The manager collaborates with departments and project teams for planning and timelines, improves QA services, and maintains safe working conditions. Additionally, the manager serves as the primary technical liaison with clients. Operating under GLP and GCP guidelines (GAMP5, 21 CFR Part 11, etc.), the Manager supports quality systems by monitoring compliance and facilitating continuous improvement through the conduct of study audits, process audits, facility audits, vendor qualifications and facilitating sponsor audits and inspections.

YOUR KEY RESPONSIBILITIES

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• Lead/manage/supervise [specific function, e.g., R&D projects, GMP manufacturing, client interactions]
• Provide [scientific/technical/operational] input to drive innovation and efficiency
• Ensure compliance with [relevant industry regulations, e.g., GMP, ISO]
• Support [business development, regulatory submissions, technology transfers]
• Mentor and guide a team of [#] professionals, fostering a culture of growth and excellence
• Lead all aspects of and drive the Bioanalytical lab operational readiness plan to ensure on-time approval of analytical equipment and test methods needed for GLP testing.
• Build a trained, competent team of QA analysts to support GLP testing.
• Coordinate daily Quality Assurance activities for Molecular, Viral, Cell, and Tissue Culture operations and contract testing. 
• Ensure compliance, accuracy, and timeliness of testing processes. 
• Lead the introduction of new technology, equipment, methodologies, and validations. 
• Provide QA leadership and support across the VVS organization. 
• Facilitate cross-functional communication and ensure all testing processes, metrics, and departmental goals are achieved.
  · Strive to implement and improve systems and drive efficiency throughout the organization.
  · Support internal, external, and regulatory inspections as needed. 
• Serve as primary QA Bioanalytical contact for regulatory inspections and client audits.
• Hire and develop employees within the department. Assign work, coach staff, and take vi