Job title: Head/Associate Director GCP Inspection Readiness (Hybrid)
Company: Takeda
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Job Description
Job Title: Head GCP Inspection Readiness
Location: Cambridge, MA (Hybrid role)
About the role:
- Establish standards for excellence in GCP inspection readiness to optimize effective and consistent performance within CQA and for R&D clinical trial stakeholders
- Provide support (e.g., guidance, training, recommendations, workstream participation, etc.) to CQA Therapeutic Area Units and CQA Regions for specific GCP inspection readiness projects
- Interpret CQA quality metrics to identify and communicate inspection risks and liaise with R&D and R&D Quality functions to drive organizational process improvements
How you will contribute:
- Provides GCP technical expertise in support of sponsor and site Health Authority (HA) inspection preparation, management, logistics and response activities.
- Works in close collaboration with Head of Inspection Management and Head of GCP Process Excellence to determine the inspection management strategy and execution activities for site and/or sponsor inspections.
- In consultation with CQA TAU Heads, CQA Region Heads and Head of CQA, provides CQA Inspection Readiness workstream support (e.g., workstream lead/co-lead or participating member) for sponsor inspection readiness activities, as necessary.
- In consultation with CQA TAU Heads, CQA Region Heads and Head of CQA, provides support (e.g., technical expertise, guidance, advice) to key members of the inspection team during an on-site or remote Health Authority sponsor or site inspection.
- In consultation with CQA TAU Heads, CQA Region Heads and Head of CQA, helps identify CQA representatives to fill various sponsor inspection support front room and backroom roles including Host, Front Room Liaison, Scribe, QC Reviewers, etc. and provides training, as necessary. May support inspections in the front room and back room (e.g., training, strategy, front room and back room QA roles).
- As part of cross-functional team, evaluates proposed HA commitments in response to inspection findings and ensures commitments are robust, realistic and delivered timely if there are global process or system related commitments.
- In consultation with CQA TAU Heads, CQA Region Heads and Head of CQA, assess outcomes of site and sponsor inspections and conducts lessons learned sessions to ensure process improvements are implemented timely.
- Works in close collaboration with the R&D Head of Inspection Management to develop future strategies to HA inspection management and logistics for CQA.
- Provides support as necessary (i.e., training, guidance and/or tools) with inspection readiness activities for anticipated or announced investigator site and/or sponsor inspections.
- Supports pre-submission audits and/or inspection preparation visits at investigator sites (e.g., reviews and comments on audit plans) that focus on inspection preparation, mock interview training and inspection logistics, as necessary.
- Create and/or revise the inspection process, tools and templates in CQA, as needed.
- Support revisions to the inspection readiness and inspection management RACI and playbook in CQA.
- Develops inspection readiness toolkits for various health authorities, so expectations for site and sponsor inspections are well understood.
- Supports (e.g., provides and/or supplements) mock interview trainings with the study team, SMEs and functional representatives in preparation for anticipated or announced inspections, as necessary.
- Lead and coordinate and ensure execution of mock inspections.
- Interview, hire, onboard and management mock inspectors.
- Put contracts and SOWs in place with mock inspectors.
- Oversee the creation and maintenance of inspection readiness dashboards for key programs.
- Consult with the CQA TAU Heads, CQA Region Heads and/or the Head of CQA to share systemic and/or critical issues and recommend appropriate solutions for immediate and long-term resolution.
- Conduct and share insights and trends related to inspection findings, CAPAs and process improvements at various Takeda quality councils, compliance forums and/or CRO governance meetings.
- Develops and drives continuous improvement processes and activities to mitigate risks, ensure best practices and promote a state of inspection readiness within CQA.
- Host monthly inspection review board meetings to provide oversight and ensure there are robust CAPA plans stemming from investigator site inspections, sponsor inspections and mock inspections.
- Ensure entry, tracking and closure of inspection findings, CAPAs and CAPA effectiveness checks stemming from investigator site and sponsor inspections in Trackwise.
- Review CAPA evidence for global process or system related commitments and provide support with the timely closure of CAPAs.
- Maintain the inspection tracker for GCP site and sponsor inspections, so there is awareness of which inspections are planned and/or completed.
What you bring to Takeda:
- BA/BS degree required; advanced degree preferred.
- 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
- Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
- Requires approximately 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
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 environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
Salary:
$143,500 – $205,000 +/- 10-% based on experience.
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.
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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.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Expected salary:
Location: Boston, MA