Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Clinical Quality Assurance OPEX Lead (Associate Director) in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director working on the R&D Quality Assurance team, you will be empowered to 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, and a typical day will include:
- 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
- Lead investigations into systemic GCP quality issues, conduct internal audits of R&D clinical research processes and ensure effective risk mitigations are established
- 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\Develop a robust prospective global GCP inspection plan for anticipated submissions to health authorities and collaborate with CQA Program Leads to ensure R&D teams are proactively planning for inspections
- Collaborate with R&D on a knowledge management framework to build inspection readiness as trials are ongoing
- 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
- Lead investigations into systemic and/or cross-program 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.
- Lead the planning, execution, and follow-up of internal audits of GCP processes. 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.
- 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
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- 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 analyse 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 30% travel.
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
- Community Outreach Programs.