Posted to MedZilla on 4/22/2018


Takeda Pharmaceuticals

US-MA, Manager, Nonclinical Quality Assurance R0000657-MZ


 
 

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Job Description

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:

POSITION OBJECTIVES:

  • Qualifies nonclinical service providers conducting GLP studies and IND-enabling DMPK and Pharmacology studies.
  • Assures integrity of non-clinical parts of Common Technical Document.

POSITION ACCOUNTABILITIES:

  • 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

LICENSES/CERTIFICATIONS:

  • RQAP-GLP preferred

PHYSICAL DEMANDS:

  • Office work

TRAVEL REQUIREMENTS:

  • 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.

#LI-LC1

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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