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 Program Manager in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Program Manger working on the R&D Quality team, you will be empowered to coordinate and support execution of the risk-based GCP supplier audit and compliance strategy, and a typical day will include:
- Under supervision, manage audits of GCP suppliers for clinical development, GMA, and MPG studies
- 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
- Coordinate and contribute to the development of a risk-based GCP supplier audit and compliance strategy for the CQA function
- Develop and maintain the global supplier audit management plan in accordance with Takeda procedures
- Provide quality and compliance oversight for GCP suppliers, including but not limited to coordinating the development and execution of Quality Agreements and partnership communications/meetings, as required
- Lead and execute lower risk supplier audits in compliance with GCP and Takeda policies and procedures. With supervision, 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.
- Support GCP supplier governance council meetings
- Generate metrics and develop reports on GCP supplier quality performance for CQA management
- Liaise with internal Takeda key stakeholders and external business partners to provide guidance and support pertaining to compliance and supplier quality oversight initiatives
- 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
- Participate in GCP health authority inspections as required
- Develop and/or review procedures and participate in process improvement initiatives, as needed.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor s Degree required; Advanced Degree preferred.
- Minimum of 5 years of experience in the pharmaceutical, biotechnology or related health care industry;
- Minimum 2 years GCP auditing or relevant clinical trial experience preferred
- Knowledge and/or awareness of ICH GCP R2 and applicable global regulations and guidance for clinical development
- Knowledge of 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 audit reports and procedures.
- Ability to communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing.
- Solid judgment, project management and decision-making skills; able to prioritize and manage multiple projects and demanding timelines
- 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 20-30% 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.