Quality Manager (Quality CMO oversight)
Company: Takeda Pharmaceutical
Posted on: March 19, 2023
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information I provide in my application will be processed in line
that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionAbout the role:
- The Quality CMO oversight team is accountable for oversight of
Biologics product manufactured at CMOs on behalf of Takeda.
- The scope includes Drug Substance, Drug product and Finished
Drug Product CMOs
- This team will work with our external CMO partners and internal
Quality teams within this department .In addition this function
works closely with External Supply , Supply Planning, Technical
support and other stakeholders involved in external supply.How
you'll make an impact:
- This person is the Quality contact for CMO(s) maintaining
oversight at those CMOs for Quality related topics
- Is the Quality representative on the External Supply team and
works collaboratively with this cross functional team and CMO to
facilitate supply of product to our patients according to Takeda
SOPs and GMP standards
- Prepares for and attends relevant CMO governance meetings and
internal Takeda meetings. Leads applicable meetings with the
- Resolves quality related topics and escalates where further
input is required
- Is the Quality contact/approver for Quality documents from
CMO's and CTL's, as applicable.
- Maintaining and improving CMO quality metrics that incorporate
continuous improvement methodologies. Responsible to recommend
actions as a result of such reviews / reports.
- Supports internal audits and Health Authority inspections as
- Leading or supporting CMO/ Quality projects.
- Generation / review of CMO quality agreements to ensure
agreements are current and within date.
- Review of CMO Annual Product Quality Reviews
- Support investigations into complaints as required
- Support product launches activities associated with CMO's
- Represent management in meetings and cross functional
- Quality assurance manager oversight and approval on all
applicable quality systems pertaining to CMO management including
but not limited to Deviations, Change Controls, CAPAs.
- Analysis of CMO management processes, development of quality
improvement plans and continuous improvement.
- Providing escalation, weekly updates, reports and stats to
management as required.DIMENSIONS AND ASPECTSTechnical/Functional
- Bachelor's degree in chemistry, biology, pharmacy or a related
- The person will have a thorough knowledge of GMPs and Quality
- Quality experience in parenteral biological manufacturing
particularly in the manufacture of sterile medicinal products,
manufacture of biological active substances and products and
manufacture of Finished Drug product.
- Experience with collaborative working with Contract
Manufacturing Organisations (CMO)
- Experience with leading and adopting Agile and Continuous
- This person will work in collaboration with the CMOs, Takeda
CMO/CTL teams ,Quality teams and cross functionally with external
supply, planning , technical and other stakeholders .
- Good communication and interpersonal skills are required.
- Demonstrates Takeda values in roleDecision-making and Autonomy
- Review and approval of CMO documents
- Evaluation of CMO's Quality Management Systems to ensure
appropriate level and content of reporting, including technical
evaluation of quality system reportsInteractionInternal (including
but not limited to)
- Quality Leadership Team
- Disposition Team
- Technical services
- Supply Chain & Customer Services
- External Supply and Manufacturing
- Regulatory Affairs
- Pharmaceutical and Analytical Development
- Process DevelopmentExternal (including but not limited to)
- Contract ManufacturersInnovation
- The person will manage continuous improvement initiatives in
the CMO oversight team and support continuous improvement
initiatives in Biologics external supplyComplexity
- The scope of this role spans Drug Substance, Drug Product,
Finished Drug Product manufactured at multiple CMOs across the
region.What you bring to Takeda:
- 8 + years' experience working in manufacturing and/or Quality
to support the manufacturing of biologic products.
- Thorough understanding of quality systems and cGMPs.
- Interpersonal skills and communication skills to interact with
CMO partners and other functions.
- Must be able to prioritize in a busy environment.
- Must be able to travel up to 20% (domestic and
- Must be fluent in EnglishMore about us:At Takeda, we are
transforming patient care through the development of novel
specialty pharmaceuticals and best in class patient support
programs. Takeda is a patient-focused company that will inspire and
empower you to grow through life-changing work.Certified as a
Global Top Employer, Takeda offers stimulating careers, encourages
innovation, and strives for excellence in everything we do. We
foster an inclusive, collaborative workplace, in which our teams
are united by an unwavering commitment to deliver Better Health and
a Brighter Future to people around the world.Empowering our people
to shine:Takeda is proud in its commitment to creating a diverse
workforce and providing equal employment opportunities to all
employees and applicants for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, gender
expression, parental status, national origin, age, disability,
citizenship status, genetic information or characteristics, marital
status, or any other characteristic protected by law.LocationsIRL -
Dublin - Baggot StreetWorker TypeEmployeeWorker Sub-TypeRegularTime
Keywords: Takeda Pharmaceutical, Dublin , Quality Manager (Quality CMO oversight), Executive , Dublin, California
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