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Job Description
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Associate Director, Quality Assurance (QA) Cell Therapy (CT) 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.
POSITION OBJECTIVES:
The Associate Director, Quality Assurance (QA) Cell Therapy (CT) is responsible for oversight in making quality decision associated with Quality Assurance at the Massachusetts Biologics Operations (MA Bio Ops) at Lexington. You will be responsible for:
Quality approver on cGMP investigations, Corrective/Preventative Actions, Change Controls, and procedures
Draft required SOPs for QA to support the CT operation
Review and approve batch manufacturing records as well as engaging with manufacturing personnel to ensure product is manufactured in accordance with site procedures
Collaborate with manufacturing and support functions, this function will entail as necessary aspects process troubleshooting, and key decision
Partnership with operations and various support functions for defending the Cell Therapy programs and cGMP decisions to Regulatory Agencies and Site / Corporate senior leadership, as necessary
Collaborate with leadership counterparts across other areas within Quality, Supply Chain Management, Technical Services, and most importantly, the operations units the department supports
POSITION ACCOUNTABILITIES:
Identify SOPs required for QA CT
Analyze the gaps with corporate guidance, network with other sites, draft the new SOPs or revise the existing ones from MA Bio operations to align CT operations
Support qualification and validation program of new CT facility
Review and approve the tech transfer plan and associated work
Draft, review sections associated with IND and BLA
Support functions to cover meetings and provide support to the quality control labs
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Bachelor’s degree in science or bioengineering
10+ years of experience in Quality Assurance / Technical Services in biotech industry, and cGMP manufacturing
A thorough understanding of requirements / regulations related to a cGMP environment.
Strong knowledge of biological or cell culture-based manufacturing processes
Experience interacting and collaborating with cross-functional global teams related manufacturing, QA, and engineering
Experience in interacting with health authorities including direct involvement with agency inspections
Preferred Requirements
Master’s degree or higher studies in related discipline
Cell Therapy commercial manufacturing experience
Other Job Requirements
Domestic and International Travel is expected to be minimal <5%.
Key Skills, Abilities, and Competencies
Ability to make difficult, robust, rationalized, and timely decisions balancing the totality of available data and risk
Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, enable trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team
Adopt and exemplify the Takeda Values throughout the Organization: Integrity, Fairness, Ability to interact effectively with Health Authorities and various Takeda stakeholder
Complexity and Problem Solving
Responsible for proposing and supporting cGMP investigation strategy and execute agreed upon strategies
Provide leadership and effective decision making in the event of unplanned manufacturing issues
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
