Job Title: External Supply Quality, Manager
Location: Lexington, MAAbout the role:
You will have responsibility for Quality Assurance, and support of Quality Control, for external Oncology and Small Molecule manufacturing (contract manufacturing organizations, or CMO) and external testing (contract test labs, or CTL), inclusive of API, DP, packaging and labeling activities, located within the US/North American region.
You will support the strategy and plans for the ESQL Quality organization to meet the Quality and Operating Unit vision and objectives, assist in establishing priorities and building a regional patient-centered best in class organization, execute on Quality Improvement projects.How you will contribute:
What you bring to Takeda:
- Accountable for the product quality performance at designated CMOs, to ensure compliance and quality risks are identified, communicated and mitigated, and are an integral part of business decisions consistent with cGMP and Takeda Global Quality Standards.
- Responsible for product quality performance through product and supplier Quality Risk Management, deviation/investigation review, change management, APQR evaluation, supplier auditing, Key performance Indicators (KPI) and other Quality processes and tools as required. Maintain product and process. Supports an environment of continuous improvement.
- Supports and champions implementation of compliance strategies, quality plans and Commercial Quality Assurance programs for the management of Takeda outsourced material procurement, product manufacturing/packaging operations to assure the quality and compliance of Takeda and partner products.
- Represent Takeda to make decisions on acceptability of quality programs and ongoing activities at the CMO.
- Establish quality and compliance expectations for CMOs and CTLs; performing strategic systems reviews and coordinate risk/benefit analyses of supplier processes and systems to assure compliance with cGMP's and Takeda Quality System expectations.
- Provide oversight in the assessment of changes or deviations for Takeda products, to assure compliance to regulatory commitments, assessment and evaluation of risks, appropriate disposition of product, and correction or improvement of operations to minimize future risks.
What Takeda can offer you:
- Bachelor's Degree in Pharmacy, Chemistry, Biology or related discipline
- 8 years of QA/QC experience in the pharmaceutical industry and/or QA/QC laboratory environment.
- Experience with cGMPs, ICH and other relevant regulations
- Project Management expertise desired.
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- 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 and company match of charitable contributions
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
- Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
This job posting excludes CO applicants. More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations
Lexington, MAWorker Type