Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior External Supply Quality Professional 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 Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
This position has responsibility for direct day-to-day oversight of 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 respective region.
The role holder supports the development and execution of the strategy and plans of the ESQL Quality organization to meet the Quality and OpU vision and objectives. The Quality Professional helps elevate organizational performance and support or executes on Quality Improvement projects internally and with the CMO/CTL.
- Oversee Quality System activities at CMO/CTL to ensure compliance with current Good Manufacturing Practice (cGMP) regulations and Takeda quality expectations.
- Accountable for Quality leadership of investigations into systemic and major product/process non conformances and deviations to ensure compliant and timely resolution and monitor corrective actions.
- Works with key vendors to lead or promote initiatives that support market or regulatory changes in support of Takeda products.
- Ensure product integrity, and regulatory compliance through approval of changes to specifications, records, methods and other key quality documentation.
- Lead or assist in comprehensive Quality Systems audits of existing Takeda suppliers to assure continued compliance with cGMPs and Takeda quality expectations. Lead or assist in audits of proposed suppliers in support of Takeda commercial product business needs. Make recommendations to Takeda management concerning the use of suppliers based on audit findings.
- Identify process optimization/cost improvement projects for Takeda marketed commercial products and quality systems.
- Represent Takeda Commercial Quality during critical projects or start-up activities at CMO/CTL to assure all Takeda quality and project expectations are met.
- Champion the development and implementation of Quality Assurance guidelines, policies, and procedures as necessary to ensure compliance with regulation and Takeda requirements.
- Can serve as Quality authority on project teams composed of R&D, Pharm Development, Manufacturing Technology, ESOLs, Regulatory, Supply Chain, Marketing and others, as appropriate.
- Disposition Takeda product for marketplace, as needed.
- May represent Takeda during regulatory agency inspections at supported CMO/CTL.
- Additional duties as assigned.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelor's Degree in Chemistry, Engineering, Biology, or related
- Minimum 6 years of QA/QC experience in the pharmaceutical industry
- Minimum 8 years experience in pharmaceutical manufacturing, packaging, or laboratory environment
- 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.