- Lead a team with responsibility for dispositioning Biologics product in Takeda s external contract manufacturing organisation for Drug Substance, Drug Product and Finished Drug product manufacturing.
- The incumbent initiates,manages and improves quality aspects of CMO relationships to enable disposition of Takeda products to our patients which meet both the Takeda and Health Authorities GMP standards.
- Build and develop the Batch Disposition Team and be responsible for its people, budgets, KPIs and continuous improvement .
- The incumbent will work closely with colleagues in external supply, technical services, planning,regulatory and other functions as required to meet the needs of patients and the business.
- This position will be responsible for the timely disposition of product in line with global regulatory guidelines and Takeda standards.
- The incumbent will provide overall team leadership and will manage the day to day activities of the department and direct reports incuding budget and resources needed to deliver on business goals.
- The incumbent must build and maintain strong relationships with key internal and external partner organizations and will be expected to develop and deliver shared objectives with key partner groups.
- The incumbent is accountable for delivering on External Site Quality goals and key performance indicators
- Define the capability needed to deliver services and actions to maintain and continuously improve processes
- The incumbent will lead and marshal the appropriate resources needed to quickly resolve complex quality related manufacturing issues ensuring root cause determination and appropriate CAPAs
- The incumbent will engage with the regulators , primarily FDA,as required
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Requires a minimum of a Bachelors degree in a scientific/technical discipline with minimum 15 years experience in Quality Disposition in Biologics/sterile manufacture and industry managerial experience within commercial manufacturing (both highly preferred).
- 15 or more years experience leading and managing highly effective quality, technical, manufacturing and/or operations teams and developing people and in particular batch disposition teams
- Track record of effective Quality disposition for both internal and external production facilities
- Recognize the importance of meeting patient, compliance and business needs
- Experience in a multinational organization effectively navigating differing regional expectations and regulations
- Experience leading, training and/or implementing root cause analysis and effective investigation practices
- Experience interfacing with regulatory bodies
- High level of professional competence. Preferably demonstrated by objective certification.
- Travel required approximately 30% (national 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.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.