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.

Salary Range: $125,000 - $140,000

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 vital disciplinary actions.
• Provide support for method development, qualification and validation from Assay Development and Analytics and/or clients.
• Support the establishment and/or enhancement of QA and operational metrics.
• Represent Ardena Bioanalysis in QA-related initiatives across the Ardena Group and external regulatory forums.
• Provide frequent overall departmental feedback to senior management.
• Ensure adequate staffing is hired and trained.

YOUR PROFILE 

• BS required, MS preferred in a scientific/technical field. PhD in a scientific/technical field is a plus.
• 6+ years of experience in a quality position within the biological and/or pharmaceutical industry required.
• Significant experience in supporting functional areas (e.g., PD, Manufacturing, QA, Engineering, EHS) preferred.
• Experience with writing Deviations, Lab investigations, and OOS required; experience with Root Cause Analysis required.
• 3 years’ experience leading teams in a fast-paced environment required.
• Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities required.
• Mathematical and reasoning ability.
• The ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to work effectively under extreme pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
• Be accessible to pilot plant area(s) and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
• Good negotiation and reasoning skills.
• Excellent written and verbal communication skills. Capable of writing reports, business correspondence, and procedure manuals.
• Proven expertise in GLP, GCP, audit coordination, and QMS ownership.
• Solid understanding of GLP, GCP and international quality standards (OECD, EMA, FDA)
  · Strong organizational skills; ability to prioritize and lead through complex processes/projects
• Well-honed problem-solving skills, including innovative and creative solutions.
• Well organized with ability to handle multiple activities simultaneously.
• Self-starter with ability to work with people at all levels within Ardena and within customer organizations.

  WHAT WE OFFER

At Ardena, we recognize that our people drive our success. We offer:

✔ A competitive salary with a tailor-made benefits package, including: medical, dental and vision benefit effective day one of employment
✔ Paid Time Off
✔ A dynamic, global work environment with career growth opportunities
✔ Access to Ardena Academy, our internal learning platform for professional development
✔ A chance to contribute to groundbreaking drug development projects that make a real impact

HOW TO APPLY

Want to know more? Contact [Hiring Manager Name] at [Email] or call [Phone Number].

Ready to start your career path with Ardena? Click the application button and join us in shaping the future of drug development!