Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, IMP Quality Advanced Therapies in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Associate Director, IMP Quality Advanced Therapies working on the R&D Quality team, you will be empowered to Develop and implement IMP Quality infrastructure , and a typical day will include
- The Associate Director, IMP Quality Advanced Therapies is responsible for developing and executing quality strategies which ensure advanced therapy (e.g. cell and gene therapy) Investigational Medicinal Product (IMP) utilized in Takeda clinical studies is produced in compliance with applicable regulations and Takeda quality expectations, and is released in a timely manner to meet clinical study and developmental timelines.
- This position directly manages the development, implementation, and maintenance of GMP quality operations and in-house GMP manufacturing which supports pharmaceutical development and the IMP supply chain (manufacturing, packaging, testing, and distribution) for advanced therapy programs.
- The Associate Director, IMP Quality Advanced Therapies ensures execution of continuous improvement through idea development, plan creation, implementation, and championing project management methodology for projects of high complexity and risk.
- Develop and implement IMP Quality infrastructure (e.g. SOPs, training) necessary to support Pharmaceutical Sciences GMP efforts in new modalities and technologies (e.g., cell and gene therapy, digital technologies) ensuring quality systems are aligned with unique patient and dosing requirements of such new modality products.
- Interact with and influence outsourced-based vendor personnel in execution of strategy and identification of continuous improvement opportunities which ensure Takeda quality expectations, minimize compliance risk, and uphold current Good Manufacturing Practice (cGMP) compliance.
- Responsible for oversight of IMP quality operations for both internal manufacturing and across a globally-outsourced supply chain in support of Takeda s developmental strategies, while assuring patient safety, product quality and compliance with regulations in advanced therapies.
- Ensure IMP sponsor responsibilities are fulfilled in order to ensure compliant release of IMP for use in Takeda clinical studies in advanced therapies, maintaining expertise in the global regulatory requirements for advanced therapy products.
- 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 in advanced therapies.
- Additional duties as assigned.
Education, Behavioral Competencies and Skills
- Bachelor s Degree in Chemistry, Biology, Engineering or related field. Masters preferred.
- Minimum of 10 years of increasing responsibility and experience in the global pharmaceutical industry. At least 5 years of managerial experience
- Minimum of 7 years of Quality/cGMP Compliance experience.
- Specific experience in one or more of the following; IMPs, cell and gene therapy product manufacturing, 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 advanced therapies.
- Experience with regulatory batch release and importation, drug review and release for advanced therapy IMP products by working with stakeholders who are in charge of regulatory affairs or clinical development.
- In depth knowledge of current relevant international regulatory requirements and guidance for the pharmaceutical industry for new modality and technology (e.g. cell and gene therapy, digital health).
- 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.
- Routine demands of an office based environment.
- This role supports pharmaceutical production operations therefore the work environment may include exposure to production and processing facilities such as API manufacturing, pharmaceutical product manufacturing, packaging, component printing and analytical laboratories (this list is not exhaustive).
- Requires approximately 15% travel, both domestic and international.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.