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Senior Manager-IMP Quality (UK...

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Job Summary

Company
Takeda
Location
Delray Beach, FL
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4314_R0000754

Senior Manager-IMP Quality (UK)

About the Job

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Job Description


Takeda is a global pharmaceutical leader with more than 30,000 professionals working together across more than 70 countries. We have an unwavering dedication to put people first and we live our values of Takeda-ism: Integrity, Fairness, Honesty, and Perseverance. We are united by our more than 230-year legacy of research-based pharmaceuticals and our mission to strive toward Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Operating across 32 countries, our Europe and Canada region is diverse, dynamic and at the forefront of supporting our mission of delivering better health for patients through leading innovations in gastroenterology, central nervous system, oncology, and vaccines.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. 

Takeda has an opening for the role of Senior Manager, IMP Quality 
Objectives of the Role:
  • The Senior Manager, IMP Quality Operations (UK) develops, implements, and manages GMP compliance strategies and processes for IMP Quality and Pharmaceutical Sciences operations in the UK and EU.
  • This position is directly responsible for assurance of meeting QP requirements for Takeda IMP at third party vendors including, but not limited to, ensuring that QP Declaration and Certification requirements are properly coordinated and that the QP network has available to it all relevant information to enable the provision of QP Declarations and for batch release and importation (API to study site releases).
  • The Senior Manager, IMP Quality Operations (UK) develops the strategic direction and ensures IMP Quality support and/or oversight for GMP clinical supplies for non-core R&D clinical studies such as those for emerging markets, life-cycle/marketed products, and investigator-initiated studies.

Accountabilities:
  • Serve as primary IMPQ management & support liaison for UK and EU GMP compliance strategies.  Provide strategic quality/compliance guidance and collaborate with stakeholders across IMPQ, R&D Quality, and Pharmaceutical Sciences to facilitate the best possible solutions for quality issues.
  • Ensure IMP sponsor responsibilities are fulfilled in order to ensure compliant release of IMP for use in Takeda clinical studies, including special focus on third-party vendors and EU Qualified Person requirements.
  • Lead IMP Quality strategy and support for GMP-aspects of clinical trial material used in studies for life-cycle management, the Marketed Products Group and Takeda emerging markets.
  • Develop, implement, and support IMPQ efforts for efficient and compliant support of clinical supply needs for investigator-initiated studies.
  • Develop solutions to complex Quality issues which potentially impact Takeda’s IMP to ensure patient safety, following cGMP regulations and Takeda quality expectations.
  • Advance IMP Quality’s success in providing support to internal stakeholder strategies based on a thorough understanding of and alignment with Pharmaceutical Sciences personnel, strategy and key business drivers
  • Provide leadership to ensure timely, well-documented, and compliant resolution of quality investigations and implementation of corrective actions that maintain a continual state of regulatory compliance for Takeda’s pharmaceutical development activities and GMP operations.
  • Maintain awareness of emerging issues and regulatory trends, provide interpretation, and communicate effective impact assessments and mitigation plans to management.
  • Training of IMPQ staff in UK\EU GMP requirements
  • Act as R&D Quality’s UK\EU GMP subject matter expert during the development\revision of Takeda procedures, and also Vendor Quality Agreements.
  • Lead comprehensive GMP quality audits of vendors as necessary.  Make recommendations to management concerning use of vendors based on audit findings.
  • Additional duties as assigned.

Education and Skills:
  • Bachelor’s Degree in Chemistry, Biology, Pharmacy or related field.  Advanced degree preferred.
  • Minimum of 8 years of increasing responsibility and experience in the global pharmaceutical industry.
  • Minimum of 6 years of Quality/cGMP Compliance experience.
  • Experience with regulatory batch release and importation, drug review and release by EU/UK Qualified Person.
  • Experience working with a global outsourced-based supply chain.
  • Routinely and proactively demonstrates model of effective communication with manager, peers, cross-functional stakeholders and reports
  • Specific experience in one or more of the following; IMPs, supply chain, pharmaceutical development, process validation.
  • Experience across API, drug product, packaging and/or labelling of pharmaceutical products, preferably in global and multi-disciplinary drug development/production environment
  • Understanding and working knowledge of Quality Management Systems, ability to interpret requirements, anticipate issues, make informed decisions and respond rapidly to emerging quality situations.
  • In depth knowledge of current relevant international regulatory requirements and guidance for the pharmaceutical industry.
  • Experience in regulatory agency inspection conduct and management, action planning and responses
  • Demonstrates ability to independently distinguish between criticalities of quality issues and identify issues or topics for management escalation independently.  Able to clearly articulate issues in a timely manner.
  • Demonstrates and actively seeks to establish professional relationships and rapport with internal and external peers and higher-level management.  Experience working on teams in a complex, matrixed and global environment.  Proactive leadership of quality topic discussions.
  • Possesses developed quality reasoning skills that all him/her to be relied on as appropriate and active proxy for his/her management, as necessary
*LI-PD2-EUR

Locations

London, Great Britain

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
 

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