Director, Quality Systems

3 months ago

Boston, United States Stratacuity: Proven Scientific Placement Full time

Location: Boston,MA (Hybrid / Onsite)

Therapeutic Area: Small molecule Pharma

Job Overview: The role requires leading the development, design, and maintenance of the Quality System to ensure efficiency, effectiveness, and compliance with quality regulations and standards, reporting to the Head of Quality Assurance.


Primary Job Responsibilities:

  • Ensure compliance with cGXP regulations by evaluating and advancing quality standards
  • Oversee the design, development, and maintenance of Global GxP e-Quality Systems aligned with business processes
  • Manage the corporate cGxP training program and collaborate with department heads to develop training curriculums for GxP personnel

Primary Job Requirements:

  • Bachelor's Degree in Life Sciences or a related field
  • A minimum of 10-12 years of increasing responsibility in cGMP/Quality Management Systems
  • Experience with Veeva Quality Vault eDMS/eQMS and Compliance Wire eLMS
  • Candidates must have prior experience in FDA regulated environments and familiarity with Health Authority regulations and guidance

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.

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