International QA Director

Holbæk, Denmark

Pharmacosmos

International QA Director

About the job International QA Director
Join Pharmacosmos as they embark on their next growth phase in a QA position with an international outlook, offering broad responsibilities, significant influence, and a high level of independence.
Set quality standards through strategic and operational initiatives
In this position, you will become a part of a team bringing new drugs to the market from early clinical trials to fully commercialized products. Your primary responsibility will be to ensure that Pharmacosmos external and outsourced activities comply with requirements, applicable rules for good manufacturing and distribution practices (GMP and GDP), and other relevant regulations. As such, you will oversee that quality is maintained by all CMOs, vendors, subsidiaries, and partners, focusing on aseptic, sterile, and tableting contract manufacturing. Likewise, you will participate in technology transfers between external stakeholders to supervise development projects and conduct surveillance and audits of external manufacturing and packaging sites, ensuring compliance with the quality agreement, cGMP, and GDP. Additionally, you will be responsible for preparing, reporting, and presenting essential inputs on your key project deliveries for internal quality business reviews. Cross-functionally, you will work closely with colleagues in Regulatory Affairs, Supply Chain, Internal Quality, Quality Control, CMC, and Clinical. Finally, as this is a position with an international focus, you should expect some travel activity.

Strong QA profile with CMO management experience
We expect you to hold a relevant scientific background from the life science field, combined with extensive experience in QA positions within the pharmaceutical industry, providing you with a strong understanding of quality processes, GMP/GDP regulations in aseptic and sterile manufacturing, tableting, CMO management, external audits, and quality agreements. Based on your experience, you have a clear understanding of customer needs as well as driving process improvement initiatives. Furthermore, it is crucial that you possess excellent interpersonal skills, enabling you to communicate effectively at all levels and present complex ideas with clarity. Lastly, you are fluent in Danish and English, both written and spoken.

Personally, you are analytical, independent, action-oriented, and decisive. Collaborating with different people at all levels in an organization comes naturally to you, and you thrive in a position, where you get to challenge the status quo and set a clear direction that inspires the people around you. You are a strong ambassador of a quality mindset, and you have a proactive and solution-oriented approach. You enjoy working in an organization with a dynamic pace and a broad range of tasks and responsibilities, requiring you to balance risk and value to ensure quality and safety.

Unlock innovation and accelerate growth with Pharmacosmos
This is your chance to embark on an exciting journey with Pharmacosmos, as they continue to seize strategic opportunities, driven by a strong ambition to benefit more patients globally and address unmet medical needs. The recruitment process is carried out by Venaris Executive Search. For more information regarding the position, please reach out Head of Research, Sofie Rudbech Mathisen, at [email protected]. All requests will be handled confidentially. If this position is for you, do not hesitate to apply by uploading your CV - it is not necessary to include a cover letter.

Pharmacosmos
Founded in 1965, Pharmacosmos is a global healthcare pioneer in carbohydrate chemistry and a leader in the development of innovative treatments for blood diseases, including iron deficiency anemia and cryopreservation technology. On September 18th, 2024, Pharmacosmos announced the successful completion of their acquisition of G1 Therapeutics, a commercial-stage oncology company. The acquisition aligns perfectly with Pharmacosmos' strategy by leveraging their extensive expertise in blood diseases, positioning the company for its next phase of growth and strengthening its global commercial portfolio. Headquartered in Holbæk, Denmark, Pharmacosmos employs 650 dedicated employees, with products marketed in over 40 countries worldwide. Please also visit www.pharmacosmos.com