at Takeda Pharmaceuticals in Montpelier, Vermont, United States
Job Title: Senior GCP Supplier Quality Manager (Remote)
Location : Cambridge, MA
About the role:
+ Develop and implement the GCP supplier audit plan for clinical development programs and studies
+ Oversee audits for strategic partners and key GCP suppliers
+ Manage and escalate identified compliance risks, ensuring appropriate mitigations are implemented
+ Lead and/or participate in GCP sponsor and supplier oversight initiatives
+ Provide professional expertise and leadership in applicable guidance and regulations, proactively identifying potential areas of non-compliance and risk to R&D Business Partners and Takeda
How you will contribute:
+ Provide professional expertise and leadership in GCP guidance and regulations, proactively identifying potential areas of non-compliance and risk for suppliers
+ Develop and implement the risk-based GCP supplier audit and compliance strategy and manage supplier audits in compliance with GCP and Takeda policies and procedures. Audits require advanced auditing skills and may involve technically complex assignments. Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CQA management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures
+ Provide support as needed for quality governance council meetings
+ Liaise and collaborate with internal Takeda and external business partners to provide guidance and support pertaining to compliance and supplier quality oversight initiatives
+ Analyze audit metrics and develop reports for management
+ Lead investigations into significant 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
+ Collaborate with Quality Compliance and Systems team to identify and mitigate cross-GXP supplier related quality and compliance issues
+ Lead process improvement initiatives as requested by management
+ Participate in GCP health authority inspections, as required
What you bring to Takeda:
+ Bachelor’s Degree required; Advanced Degree preferred
+ Minimum of 7 years of experience in the pharmaceutical, biotechnology or related health care industry
+ Minimum 5 years GCP auditing or relevant clinical trial experience preferred
+ Extensive knowledge and/or awareness of ICH GCP R2 and applicable global regulations and guidance for clinical development
+ Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity
+ 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, audit 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
+ Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
+ Requires approximately 20-30% travel.
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.
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.
This posting excludes Colorado applicants.
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.