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Associate Director, R&D Quality

Cambridge, MA

Posted: 12/14/2020 Employment Type: Direct Hire Job Category: Clinical: Quality Job Number: 2694

Job Description

Reporting to the Vice President of R&D Quality, the Associate Director, R&D Quality will be responsible for the design, development and implementation of a Quality Management System (QMS) for Research & Development (R&D). The individual will primarily work with the R&D organization (e.g., Clinical Development Organization (CDO), Safety, Non-Clinical, etc.) and R&D Quality colleagues to ensure development of a QMS that is fit for purpose for R&D including all applicable elements of a QMS (i.e., Policies & Procedures, Knowledge Management, Issue Management, etc.). This individual will also be responsible for conducting periodic assessments of the R&D QMS to facilitate continuous improvement and to maintain an awareness of the health of the QMS. This individual will support the R&D QMS and drive continuous improvement of clinical, pre-clinical and pharmacovigilance services to the client' s R&D organization. She/he will work on assignments requiring considerable judgement and initiative, understands implications of work, and makes recommendations for solutions. The successful candidate must have experience in a biotech or pharmaceutical GCP, GLP and/or GVP environment.

Responsibilities include:
  • Execute and/or oversee assessment of the R&D QMS
  • Partner with R&D functions (e.g., Clinical Development, Safety and Non-Clinical) to collaborate
  • Aide in the establishment and maintenance of R&D policies and procedures
  • Review, approve and maintain procedural documents (e.g., policies, procedures, etc.)
  • Track procedural documents for periodic review/revision to ensure continued applicability to client practices
  • < 5-10% Travel

  • BS in a scientific discipline with at least 12 years’ experience in pharmaceutical / biotech industry within Quality Assurance and/or Quality Management Systems
  • Preferably prior experience in GCP, GLP, GVP auditing or operations experience
  • Outstanding communication skills (verbal and written)
  • Ability to manage multiple projects in a fast-paced environment
  • Familiarity with Veeva
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment
  • Advanced understanding of R&D Quality Management Systems and applies knowledge and skills to complete a wide range of tasks
  • Familiar with a variety of the field' s concepts, practices, and procedures
  • High degree of independence. Requires very limited supervision when acting or making decisions within existing policies and practices. Relies on experience and judgment to plan and accomplish goals.

Meet Your Recruiter

Aaron Goldman
Principal Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past nine years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!

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