Job Description
Otsuka Novel Products GmbH (ONPG) is an affiliate of Otsuka Pharmaceutical Co., Ltd., a global healthcare company headquartered in Tokyo, Japan. The Group compromises a network of 168 subsidiaries and 34,400 employees in 32 countries across Europe, Asia-Pacific, the Americas, and the Middle East.
As part of Otsuka's Global Tuberculosis program, ONPG is dedicated to driving efforts to fight tuberculosis through innovative research and development, equitable access to medicines, and collaborations and capacity-building initiatives that strengthen the quality and delivery of care around the world. Rooted in the Otsuka philosophy – “Otsuka – people creating new products for better health worldwide” – we collaborate with a diverse range of organizations to pursue a shared vision, contributing focused expertise, innovation, and the resolve to end tuberculosis.
To strengthen our Quality team in Munich, we are currently recruiting for a
Senior Manager Quality Assurance - Biologics (m/f/d)
part-time (30 hours/week)
In this role, you will have quality oversight of the latest approved biological product at Otsuka, ensuring manufacturing, packaging, labelling, storage and transport is in accordance with regulatory expectations, applicable GMP/GDP standards for biologics and corporate requirements. You will bring Biologics Quality Assurance support, including oversight of upstream and downstream manufacturing processes, by collaborating with other Otsuka affiliates based in the US, Japan and relevant CMOs in Germany and the US.
You will be an integral part of the ONPG QMS, working closely with the releasing QP, and acting in the legal role of Deputy Head of Production.
- Batch record review for API and bulk product for monoclonal antibody prefilled syringes
- Assessment and documentation of product deviations, OOS, and changes
- Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain
- Collaborate effectively within the quality department at ONPG and with other functions within Otsuka US and Japan, including participation in regular product meetings
- Participate in the revision of product-related SOP's
- Act as product SME during audits at CMOs or competent authority inspections at ONPG
- Responsible for reviewing, drafting and improving quality agreements
- Master's degree in biochemistry, biology, pharmacy, or another life science discipline
- Minimum of 5 years' proven experience in GMP manufacturing of biologics, including both upstream (cell culture, bioreactor) and downstream (purification, filtration, formulation) processes, gained in either Quality Assurance or Manufacturing
- Demonstrated expertise in root cause investigation and hands-on experience with TrackWise
- Knowledge of and experience with relevant regulations and guidance documents (AMG, AMWHV, EU-GMP/GDP)
- Experience with biological licence applications (US/EU/China/JP)
- Accurate, results driven and capable of working under strict timelines to ensure product accessibility to patients, with a willingness to work in the late afternoon or evening to respond to urgent ad hoc requests from the US team
- Native level fluency in English; German language skills are an advantage
- Occasional national/international travel may be required (max. once or twice a year)
- Proficient in Microsoft Office applications and open to adopting new technologies
- Comfortable working in a culturally diverse environment
- A crisis-proof job in the pharmaceutical industry
- Modern office centrally located near Hackerbrücke
- Above-average remuneration with company pension scheme, attractive bonus model and training opportunities
- Home office options and flexible working hours
- Monday to Thursday schedule – enjoy Fridays off
- Additional holidays on 24 and 31 December