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, Quality Assurance - Oncology and Biologics in our Cambridge, MA office.
everyone matters and you will be a vital contributor to our inspiring, bold
mission. As a working on the Commercial
Quality Assurance team, you will be empowered to collaborate with Quality Assurance leadership in order to create and implement programs to nurture and provide career
growth to members of the department, and positively impact the lives of our patients. A typical day will include:
- Providing support documentation and training via
Initiating, revising and reviewing controlled Commercial GMP documents including
SOPs, Material Specifications, investigation protocols and reports as
- Monitoring and improving quality systems by
Identifying, proposing, leading and developing recommendations for data
integrity and system improvements.
- Providing direct oversight of our Contract Manufacturing Organizations (CMOs) with responsibility
for manufacturing of assigned products up to and including Quality
Agreements and review of Audit/Inspection reports.
- Collaborating with Quality Assurance (QA) management to create and
implement programs to nurture and provide career growth to members of the
department Quality process and system improvements.
- Develop and implement strategic approaches to batch
review and disposition processes for drug substances and products.
- Managing staff and equitably distributing work to
ensure timely review of batch documentation and disposition.
- Generating and/or reviewing excursion reports to
assess compliance and disposition decisions.
- Supplier oversight via initiation, monitoring and
completion of change controls related to Quality topics.
- Leading off-site discussion and review of supplier
performance and cGMP compliance.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- A minimum of a bachelor s degree preferably in pharmaceutical sciences with a minimum of twelve (12) years in a pharmaceutical/biotechnology industry with at least ten (10) years in Quality preferably Quality Assurance, regulatory and scientific experience preferred.
- Six (6) years of leadership and management experience in Quality functions
- At least four (4) year floor experience in a pharmaceutical manufacturing facility under a GMP environment
- Extensive knowledge in cGxPs, ICH and other pharmaceutical regulations.
- Ability to interact effectively with senior management across departments.
- Ability to thoughtfully analyze information and data to make key decisions. regarding potential risks associated with product quality or regulatory violations.
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.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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