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, Quality Assurance in our Cambridge, MA office.
Here, 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 QA management to create and implement programs to nurture and provide career growth to members of the department. A typical day will include: POSITION OBJECTIVES:
- Providing support documentation and training via Initiating, revising and reviewing controlled Commercial GMP documents including SOPs, Material Specifications, investigation protocols and reports as applicable.
- Monitoring and improving quality systems by Identifying, proposing, leading and developing recommendations for data integrity and system improvements.
- Providing direct oversight of CMOs with responsibility for the manufacturing of the assigned products up to and including Quality Agreements and review of Audit/Inspection reports.
- Collaborating with QA management to create and implement programs to nurture and provide career growth to members of the department Quality process and system improvements.
Qualifications: EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- 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.
TRAVEL REQUIREMENTS: WHAT TAKEDA CAN OFFER YOU:
- A minimum of a bachelor’s degree preferably in pharmaceutical sciences with 12+ years in a pharmaceutical/biotechnology industry with at least 10+ years in Quality preferably Quality Assurance.
- 6+ years of leadership and management experience in Quality functions.
- 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.
Empowering Our People to Shine
- 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
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
No Phone Calls or Recruiters Please.
A little about us:
Takeda fosters an inclusive environment where all employees are empowered to shine.