GCP Compliance Senior Manager, Quality Event Management (Hybrid)

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Job Title: GCP Compliance Senior Manager, Quality EventManagement (Hybrid)

Location: Cambridge, MA

• Lead investigations into critical and/or major systemic GCP quality issues, and ensure effective risk mitigations are established
• Establish standards for excellence in GCP investigation documentation, inspection preparation and responses, CAPAs, and effectiveness checks to optimize effective and consistent performance within CQA and for R&D clinical trial stakeholders
• Interpret CQA quality metrics to identify and communicate compliance risks and liaise with R&D and R&D Quality functions to drive organizational process improvements

How you will contribute:

• Lead investigations into critical and/or major systemic quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities
• Provide professional expertise and strong leadership in GCP guidance and regulations
• Establish standards for excellence in GCP investigation documentation, inspection preparation and responses, CAPAs, and effectiveness checks to optimize effective and consistent performance within CQA and for R&D clinical trial stakeholders
• Collaborate with R&D on a knowledge management framework to build inspection readiness as trials are ongoing
• Perform centralized analysis of GCP quality event and investigation metrics to identify and escalate compliance risks and trends to GQ and R&D leadership
• Partner with R&D on process improvement initiatives to ensure compliance with ICH GCP quality risk management and other regulatory requirements for clinical research
• Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
• Participate in GCP health authority inspections as required
• Participate in due diligence activities and process improvement initiatives as requested by management
• Mentor and provide support to CQA personnel, as needed

What you bring to Takeda:

• BA/BS degree required; advanced degree preferred.
• Minimum of 8 years of experience in the pharmaceutical, biotechnology or related health care industry.
• Minimum 5 years of GCP related Quality Assurance experience.
• Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development
• Advanced knowledge in the management of quality events and GCP deviations, inclusive of conducting robust root cause analysis and developing CAPA plans that mitigate risks to the company, to safety and data integrity.
• Extensive experience in management of GCP quality event investigations
• Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems
• Effective technical writing skills; able to write quality positions, quality event/deviation reports, and procedures.
• Excellent communication skills with ability to negotiate and influence without authority in a matrix environment
• Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines
• Superior attention to detail and ability to analyze complex data
• GCP Quality Assurance registration/certification preferred
• Routine demands of an office-based environment
• In office requirement of two days per week
• No more than 10 percent of travel for team meetings expected

What Takeda can offer you:

• 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
• Professional training and development opportunities
• 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 environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Will work in a cold and/or wet environment.
• Must be able to work multiple shifts, including weekends.
• Non-Exempt Roles only: Must be able to work overtime as required.
• May be required to work in a confined area.
• Some Clean Room and cool/hot storage conditions.

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.

This posting excludes Colorado applicants.

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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.