Director of QA Commercial Drug Product & Finished Goods
Ascendis Pharma
Are you passionate about quality and would you like to be a part of our high performing QA team in a fast growing and innovative international company? Are you motivated to play an important role in ensuring the quality and compliance of our products and processes?
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.
Ascendis Pharma is a fast-growing, dynamic biopharmaceutical company with Headquarters in Denmark that offers you room to grow and the freedom to take responsibility and make a difference for patients every day. As a member of our global team, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.
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.
Travel: 10-15 days per year.
Office location: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals and the sea.
You can also visit out website www.ascendispharma.com (www.ascendispharma.us for US job ads) All applications must be submitted in English and are treated confidentially.
Applications will be evaluated when received, so please apply as soon as possible.
Benefits:
- You can expect an attractive remuneration package, short- and long-term incentives, pension scheme and health insurance.
- Laptop, iPhone, paid internet, and home office equipment.
- A thorough and structured onboarding program.
- To ensure a balanced approach to the office, all employees have the opportunity to work from home up to two days per week.
- Soft drinks, fresh fruit, and a wide variety of snacks every day, no strings attached.
- To succeed in your job and expand in your role, you and your manager will continuously have Impact conversations about how to propel your development. If a need is identified, we will find a way to help you grow.