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 GCP Supplier Quality 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 lead development and implementation of the GCP supplier audit and compliance strategy for clinical development programs, GMA and MPG studies, and a typical day will include:
- Serve as primary point person for key GCP strategic partners; lead key supplier quality partnership governance councils and/or internal supplier-related committees
- Liaise with suppliers to provide compliance & management support for identified issues arising within outsourced studies
- Lead and/or participate in GCP sponsor and supplier oversight initiatives related to quality
- Provide professional expertise and strong leadership in GCP guidance and regulations, proactively identifying potential areas of non-compliance and risk
- Lead the development and implementation of 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
- Lead and/or support 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
- Analyse, report, and present metrics on supplier quality performance to management; recommend any required actions and monitor implementation.
- 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
- Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
- Lead process improvement initiatives as requested by management
- Participate in GCP health authority inspections as required
- Mentor and provide support to Manager level CQA personnel, as needed
- May act as supervisor for temporary contractors
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.
- Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems
- Strong 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
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.