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 Manager of Nonclinical Quality Assurance in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager of Nonclinical Quality Assurance working on the Research Quality team, you will be empowered to ensure state of compliance for externalized GLP activities, and a typical day will include:
- Qualifies nonclinical service providers conducting GLP studies and IND-enabling DMPK and Pharmacology studies.
- Assures integrity of non-clinical parts of Common Technical Document.
- Leads and conducts Quality audits to qualify nonclinical service providers conducting GLP studies and IND-enabling DMPK and Pharmacology studies; Issue audit reports and perform follow-up actions.
- Confirms integrity of non-clinical parts of Common Technical Document.
- Ensures data integrity of IND-enabling non-clinical studies.
- Maintain GLP training program to ensure that personnel are appropriately trained to carry out GLP responsibilities.
- Reviews and audits compliance documents, SOPs, and protocols as assigned; reports findings to management as necessary.
- As required, participates in inspections and audits by regulatory agencies; investigates and resolves observations noted during audits and inspections; participates in inspection readiness activities.
- Interacts with and influences colleagues in Research functions and Research Quality in order to strategically align and facilitate harmonization of quality systems, procedures, and processes where necessary.
- Collaborates with R&D Quality Systems to maintain GLP training.
- Reading, interpreting and applying various regulations and guidance documents. Assessing compliance with said documents.
- Additional duties as assigned.
EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor degree required.
- Minimum 5 years of experience in GLP QA experience.
- Good knowledge of international regulatory requirements and industry guidelines for global GLP.
- Accreditations or certifications preferred (e.g. RQAP-GLP).
- Ability to read, interpret and apply references.
- Ability to identify issues and offer solutions in a pragmatic way.
- General knowledge of drug development process.
- Excellent written and verbal communication skills in English
- Excellent business skills such as critical thinking, strategic planning, and self-management
- Confidence to work alone or in a team
- 10-25%, domestic and international
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.