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QA Director in Lexington, MA at Apex Life Sciences

Date Posted: 11/27/2018

Job Snapshot

Job Description


Quality Assurance Director, 916617

 Job Scope & Purpose:

Our Lexington based biotech client with a pipeline focused in rare diseases is seeking an exceptional Quality Assurance Director.  The ideal candidate will encompass all aspects of Quality Assurance. This person is responsible for establishing and executing the GxP Quality System pertaining to GLP, GMP, GCP in accordance with relevant US and international regulations. If you have broad QA and QMS experience, along with a knack for working with smaller biotech teams, then apply today!  

Primary Job Responsibilities:

  • Implement and validate electronic Quality Systems
  • Lead Quality and Compliance oversight for all activities in manufacturing, nonclinical and clinical
  • Ensure GxP compliance of internal and outsourced Quality Management practices and procedures through Supplier Management
  • Establish internal Quality Systems training program
  • Develop and maintain internal and external audit programs
  • Quality Management of external partners (CMOs, CROs, etc.) to ensure compliance of manufacturing and testing of company products
  • Review and approval of test methods and release and stability data

Primary Job Requirements:

  • BS or equivalent in applicable pharmaceutical science with at least 8 years of GxP QMS (quality management system) experience in biotech or pharma
  • Small or mid-size biotech experience preferred
  • Expertise in GxP practices and industry standards
  • Experience working with multiple external vendors in a virtual environment
  • Strong Audit experience essential
  • Experience with development programs ranging from early stage to commercial strongly preferred

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us at info@stratacuity.com or 877-787-2821.

Code: RegQA

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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