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.

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 in Södertälje, we are looking for a QA Manager

WHAT YOU WILL WORK ON

QA Manager

YOUR ROLE

The Quality Assurance group plays a pivotal role in ensuring that all our API development and manufacturing processes are executed according to GMP guidelines and to provide a development phase GMP support to the operational teams.

As a QA manager you provide leadership in ensuring continuous compliance with internal and external regulations, standards, policies and procedures related to the quality and performance of company operations.

YOUR KEY RESPONSIBILITIES

• Approve raw material QC results, IPC results and CoA.
• Approve Master Batch Production Records.
• Approve executed batch records and cleaning records.
• Release of raw materials, consumables and intermediates for manufacturing.
• Release of APIs.
• Ensure compliance with the established standards.
• Approve deviations and CAPA.
• Approve OOS.
• Approve quality specifications and test methods.
• Manage and perform GMP training for all staff.
• Manage qualification of GMP-related service providers (contract QC labs and others).
• Approve SOPs and Work Routines.
• Issue new or updated SOP, Instructions, Work Routines.
• Participate in and conduct internal quality audits.
• Participate in client audits and authority inspections.
• Issue and approve validation/qualification protocol and reports.

• You have a MSc or PhD degree within the science/technology field, preferably chemistry, biotechnology, pharmacy or equivalent.
• Experience and knowledge of GMP quality system
• Knowledge of EU & FDA guidelines and regulatory agencies expectations.
• Minimum of 2 years of QA experience in a CDMO or biotech/pharma company.
• Experience from APIs and drug products intended for clinical trials is not a requirement but strongly meriting.
• You are solution driven, keeping timelines in mind.
• You are continuously looking for improvement.
• You have strong communication skills, able to listen and analyze a quality issue and explain the proposed solution in an accurate manner.
• You are flexible, a problem solver and a team player.
• You have an analytical mindset and you are comfortable in stressful situations.
• You are fluent in English.

• A true learning environment where you will have the ability to grow your skills.
• A rapidly developing and growing international company with an attractive services, product and customer portfolio.
• A dynamic working environment with nice colleagues.
• Open straightforward but also caring culture.
• Generous wellness allowance.
• We are true to our values.
• An attractive remuneration package.
• Flexible working hours.




HOW TO APPLY

Please apply before 15th of June 2025




Want to know more? Contact Hector Tremearne Ripellino at hector.tremearne@ardena.com

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




Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union) will not be given a status update. Agency calls will not be appreciated.