QA Manager GMP

If you want to take part in moving quality assurance to the next level, this is a unique opportunity!

Become part of a small and dedicated team, allowing you to use and further develop your knowledge and skills while contributing to developing innovative and first-in-class pharmaceutical products.

As QA Manager GMP at Vicore Pharma, you will play a crucial role in providing quality oversight of pharmaceutical development and manufacturing outsourced to CDMOs and the supply of investigational medicinal products for clinical trials.

With direct report to the Head of Quality Assurance, you will apply your experience and expertise within QA to ensure GMP compliance, collaborate with colleagues within the QA department, and cross-functionally work with internal and external stakeholders.

Your main tasks are (but not limited to):

• Lead the QA activities related to GMP regulations.
• Contribute to developing and implementing GMP-compliant systems, including internal SOPs and forms.
• Provide QA support related to manufacturing and analytical activities in development projects in close cooperation with Vicore’s CMC team and external CDMOs.
• Participate in CDMO selection and qualification processes.
• Handle and negotiate Quality Agreements with CDMOs.

Your qualifications are at least 5-7 years of experience in a medium to large-scale biotech or pharmaceutical organisation, preferably within small molecules. You possess an excellent understanding of EU and US GMP requirements for Investigational Medicinal Products (IMPs), encompassing both early and late-phase products. Your background includes thorough experience with GMP development and manufacturing of, preferably, both drug substance and drug product, as well as experience with preparation for commercialisation of medicinal products. Additionally, you have served as a GMP compliance or Quality Assurance Specialist, Manager, or Auditor, demonstrating your comprehensive expertise in maintaining high standards of quality and regulatory compliance in the pharmaceutical industry.

You have an MSc degree or equivalent in a relevant life science subject.

You are a person with strong individual initiative and integrity, exceptional organisational skills, and the ability to handle several tasks in parallel effectively. Proactive by nature, you excel in creating collaborative relationships and are clear and persistent in setting expectations and requirements for quality while maintaining a pragmatic and flexible approach. You thrive in dynamic environments where priorities and drivers can quickly change, and you communicate clearly with both internal and external stakeholders. Your systematic and structured approach suits a business-oriented environment, and you have a hands-on profile and an open-minded, can-do attitude.

Vicore Pharma offers an excellent opportunity to join the company at an exciting time, influence the development of the QA department and GMP area, and design your role and responsibilities.

Travelling: Approx. 10-20 days/year.

Domicile: Hørsholm, Denmark.

For more details about the job or the company, please contact Director Life Sciences, Gert Vium Andersen, Unique Human Capital on M: +45 42 95 08 83. All applications must be in English and are treated confidentially.

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Vicore Pharma
Vicore Pharma is an innovative clinical-stage biopharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential. Vicore’s lead indication is idiopathic pulmonary fibrosis (IPF), and the most advanced candidate drug, Buloxibutid (also known as C21), has been dosed in >300 patients and found to be well-tolerated. Recently, a phase 2a clinical trial with Buloxibutid was completed with patients in IPF, and the next phase, phase 2b ASPIRE clinical trial, is in preparation.

Read more at www.vicorepharma.com.

Adresse: Hørsholm, Denmark