Director of QA Commercial Drug Product & Finished Goods

Director of QA Commercial Drug Product & Finished Goods

Ascendis Pharma

Hellerup, Denmark

The role

As our new Director of QA Commercial Drug Product & Finished Goods, you will be responsible to lead and support the team performing quality oversight and QP release of drug product and finished goods. With upcoming additional markets in the increasing global footprint and several products in the development pipeline the number of CMOs and manufacturing processes will grow, and the commercial area expand. Our new Director will be responsible to support the increased supply chain demand as well as growing our procedures accordingly. You will join and lead a team of 3 competent and very dedicated colleagues and report directly to VP of QA Commercial Operations.

You will be responsible for

• Providing leadership to the QA Commercial Drug Product & Finished Goods team supporting prioritization and collaboration with internal key stakeholders and contract manufacturing organizations (CMOs)
• Drive cross functional GMP leadership and management collaboration
• QA oversight to CMOs manufacturing drug product and finished goods including but not limited to batch record review, QP disposition, documentation approval (Master batch records and printed packaging materials, deviations and change controls, validation documents, Quality agreements etc.)
• Develop and establish compliant quality processes within department and responsible stakeholder areas
• Keep abreast with changes in relevant regulations and ensure cGMP at Ascendis and CMOs
• Oversee and manage complex quality issues in an international environment and making independent decisions resulting in the best product quality
• Foster good communication and collaboration with CMOs by participating in virtual as well as physical meetings, visits, audits etc

Your professional qualifications

We are looking for a robust leader that can bring extensive knowledge to our department. Therefore, you must:

• Hold a relevant academic degree – preferably a master’s degree in pharma, medicine, natural science, or other relevant fields
• At least 10 years’ experience in a pharmaceutical manufacturing environment
• At least 5 years leadership experience
• In-depth and proven knowledge of pharmaceutical quality, GMP and regulatory requirements
• You are proficient in English at a professional level, both written and spoken

As a person you are

• A team player with collaborative mindset
• Excellent communication skills
• Flexible and agile with the ability to quickly change direction and adapt to new priorities
• Result-oriented while still maintaining open-minded and looking for improved ways of working

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Denmark      Manager and Executive      Manufacturing and Logistics      Quality Assurance      Ascendis Pharma