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Posted: 06-Sep-23
Location: Cambridge, Massachusetts
Type: Full Time
Head/Associate Director, GCP Auditing & CAPA Mgt (Hybrid)
Location: Cambridge, MA (Hybrid role,) or Zurich, Switzerland
About the role:
- Manage the CQA GCP Audit Operations team (5 - 7 FTE and contractors).
- Establish processes and standards for excellence in GCP audits, responses, CAPAs and effectiveness checks to optimize effective and consistent performance within CQA and for R&D clinical trial stakeholders.
- Conduct and/or manage the audits of R&D clinical studies and ensure effective risk mitigations are established.
- Interpret CQA quality audit 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:
- Manage the CQA GCP Audit Operations team.
- Establish processes and standards for excellence in GCP audits, responses, CAPAs and effectiveness checks to optimize effective and consistent performance within CQA and for R&D clinical trial stakeholders.
- Oversee and strategize CQA l audit operations support in line with CQA senior management strategy and CQA goals e.g., audit and associated Quality Management System, electronic system process strategy and support, audit quality control, audit planning and scheduling, CAPA tracking and any other activities that may be required.
- Oversee and develop the audit program for clinical studies and programs on a quarterly basis.
- Conduct and/or manage the audits of R&D clinical studies and ensure effective risk mitigations are established.
- Contribute to the planning, execution, and follow-up of GCP audits for clinical studies: Investigator Site, Trial Master File, Database, Clinical Study Report, Common Technical Document, etc.
- Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures.
- Collaborate with other R&D Quality sub functions on best practices and consistency of Quality Management System activities and review of R&D clinical procedures.
- Provide professional expertise and strong leadership in GCP guidance and regulations.
- Perform centralized cross-program interpretation of GCP audit and compliance 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.
- Assess impact of audit findings and other identified compliance risks to patient safety, patient rights, patient well-being, data integrity and regulatory compliance.
- Escalate systemic, critical and/or major audit findings and recommend appropriate solutions to senior management for immediate and long-term resolution.
- Perform compliance checks of principal investigators and data monitoring committee candidates by reviewing past audit, deviation and inspection history.
- Manage the CQA training curriculum to ensure appropriate assignments, as well as share metrics to promote on time completion of training.
- Participate in GCP health authority inspections, as required.
- Mentor and provide support to CQA personnel, as needed.
What you bring to Takeda:
- BA/BS degree required; advanced degree preferred.
- Proven leadership skills and experience with people development (i.e., mentoring) and/or people management, as well as project leadership.
- Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
- Minimum 7 years of GCP-related Quality Assurance or relevant clinical trial experience.
- Extensive knowledge and/or awareness of ICH GCP 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.
- Extensive experience in management of GCP investigations and inspections.
- 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.
- Hybrid role which have an in office requirement of two days per week.
- Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
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
Important Considerations:
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.
Base Salary Range: $143,500 - $205,000.
Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
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.
