Quality Manager - Disposition
Lexington, Massachusetts, Dublin, Ireland
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Quality Manager - DispositionApply Now
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as our Quality Manager – Disposition.
Our Disposition team is accountable for batch disposition for Biologics product manufactured at CMOs on behalf of Takeda.
The scope includes Drug Substance, Drug product and Finished Drug Product
The Disposition team will work with our external CMO partners and internal Quality teams. In addition, this function works closely with External Supply, Supply Planning, Technical support and any stakeholders involved in external supply.
- Reviewing batch documentation, data, certificates of analyses, technical reports and providing support to Quality Disposition personnel
- Dispositioning batches in alignment with Takeda Quality Systems and GMP regulations
- Managing, designing and implementing quality systems relating to batch disposition
- Maintaining and improving quality metrics that incorporate continuous improvement methodologies
- Facilitating, approving and providing inputs into deviation investigations, change controls, CAPA, investigations and nonconformance reviews as required
- Managing batch disposition processes as required
- Makes batch disposition decisions in compliance with Takeda SOPs and GMP regulations
- Evaluation of CMO’s Quality Management Systems to ensure appropriate level and content of reporting, including technical evaluation of quality system reports
- Evaluation of batch manufacturing records to determine assurances of safety, identity, strength, quality, or purity
- Determining impact of production / release schedule changes to commercial supply
- On-going evaluation of Takeda’s batch review / release systems to ensure efficient and effective processes are implemented with integrated continuous improvement methodologies
- You will manage continuous improvement initiatives in the batch disposition team and support continuous improvement initiatives in Biologics external supply
- The scope of this role spans Drug Substance, Drug Product, Finished Drug Product manufactured at multiple CMOs across the region
Key skills required
- You will have detailed knowledge of general analytical chemistry, microbiology, cell biology, protein structure/function and analysis, and characterization assays.
- Experience with commercial method implementation.
- Strong working knowledge of USP, EP, ICH, cGMP, FDA and EU requirements and guidelines
- Experience with lean processes
- You will have thorough knowledge of GMPs and Quality Systems
- Clear, concise communication skills, both written and spoken
- Demonstrated ability to interact professionally, to influence, and to manage conflict/differing opinions with the ability to drive solutions
Education, Behavioural Competencies
- 8 years’ + experience working in manufacturing and/or Quality to support the manufacturing of biologic products.
- Must be a QP and have experience in batch disposition.
- You will have a strong technical/Quality background with specific experience in Biologics manufacture and batch disposition.
- Must be a Qualified Person.
- Manufacturing site experience would be valuable.
- Thorough understanding of quality systems and cGMPs.
- Experience conducting audits and/or involvement in preparation for Health Authority inspections.
- Interpersonal skills and communication skills to interact with CMO partners and other functions.
- Must be able to prioritize in a busy environment.
- Must be available to travel -approx 20% (domestic and international)
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Job ID SR0038818