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 Program Manager in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Program Manager working on the R&D Quality Assurance team, you will be empowered to support the entire Clinical Quality Assurance team in audit, inspection and compliance related activities, and a typical day will include:
- Coordinate and support execution of the risk-based GCP supplier audit and compliance strategy
- Manage GCP consultant auditors and auditor partners
- Provide professional expertise in applicable guidance and regulations, proactively identifying potential areas of non-compliance and risk to Takeda
- Manage GCP consultant auditors, including identification, qualification, selection, training and management of the ongoing performance of auditors
- Assist CQA team with provision of material to contract auditors prior to audits
- Develop and maintain relationships with external auditor partners
- Coordinate the development and execution of Scope of Work, Master Service and Quality Agreements for CQA auditors and suppliers
- Develop and maintain the global GCP Supplier audit management plan in accordance with Takeda procedures
- Support GCP supplier quality governance council meetings, as needed
- Support CQA team with entry of information into audit database
- Lead periodic review of the CQA audit system
- Generate metrics reports from audit and compliance databases for CQA team analysis and reporting
- Maintain the global CQA Sharepoint site
- Assist and provide training to CQA team members on audit and compliance databases and CQA Sharepoint site
- Escalate systemic and/or critical problems to CQA management
- Participate in GCP health authority inspections as required
- Develop and/or review procedures and participate in process improvement initiatives, as needed.
- Provide miscellaneous administrative support as required.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BA/BS degree required.
- Minimum of 5 years of experience in the pharmaceutical, biotechnology or related health care industry
- Knowledge and experience in GCP, quality, and compliance to conduct responsibilities with input and direction, as needed, from supervisor and other CQA team members
- Understanding of GCP audit conduct and reporting
- Collaborative team player with a positive attitude that desires to learn and develop in CQA
- Ability to communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing.
- Strong 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.
- May require up to 20% 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.