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:
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
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.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.