Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Disposition in our Lexington, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
- This position has responsibility for managing Batch disposition activities for all products in accordance with their Registered approvals (NDA) or Marketing Authorizations, their Manufacturing Authorizations, Takeda Global Quality Standards and Procedures, and the principles and guidelines of current Good Manufacturing Practices.
- The role holder supports the development and execution of the strategy and plans for the ESQL Quality organization to meet the Quality and OpU vision and objectives , establish priorities, build a regional patient-centered best in class organization, develop diverse talent and elevate organizational performance, execute on Quality Improvement projects and where appropriate, manage the finances of the team.
- Review of batch record information from Contract Manufacturers/ Suppliers, and compilation of batch documentation for review according to Takeda requirements.
- Transfer needed information from Contract Manufacturers/ Suppliers batch documentation into Takeda systems e.g. LabLIMS and SAP/BPR
- Prepare and review batch documentation for release, including upload of batch certificates to the repository.
- Archive batch documentation according to Takeda and customer requirements.
- Perform Technical Release of products in SAP/BPR based on release certificates from Contract Manufacturers/ Suppliers.
- Maintains or adjusts review status based on events or Contract Manufacturers/ Suppliers risk
- Set-up or Maintenance of product list(s), and Quality relevant SAP/BPR master data.
- Supports Change control / CAPA activities, aligning with ESQL teams
- Additional duties as assigned.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelor's Degree in Chemistry, Engineering, Biology, or related
- Minimum 1 year of QA/QC experience in the pharmaceutical industry
- Minimum 3 years experience in pharmaceutical manufacturing, packaging, or laboratory environment or Masters degree and 1 year of experience.
- Demonstrated teamwork, initiative, and problem-solving skills
- Strong oral/written communication skills
Core Competencies / Skills
- Critical Thinking
- Digital and analytical skills
- Investigation and problem solving
- Good communication skills engaging stakeholders: site, business, network, company, regulators
- Risk identification, evaluation and management
- Continuous improvement
- Enterprise thinking, finding innovative ways to improve compliance and process
- Elevates capabilities of the organization
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
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.