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Manager, R&D Quality

Cambridge, MA

Posted: 11/03/2020 Employment Type: Direct Hire Job Category: Clinical: Quality Job Number: 2681

Job Description


Our client is seeking a Manager, R&D Quality to be based at their Cambridge, MA facility. This person will report to the Director of R&D Quality, and be responsible for auditing our client’ s suppliers and be accountable for monitoring supplier performance. S/he will also provide Quality Assurance (QA) support for our client' s R&D Quality vendor/service provider program. The individual will primarily work with R&D vendors and service providers to ensure oversight of GCP, GLP and GVP services and materials. This individual will support supplier quality systems and governance, initiate audit plans, audit vendors/service providers, and drive continuous improvement of clinical, pre-clinical and pharmacovigilance services to the R&D organization. Additionally, the individual will create and maintain data tracking systems that govern vendor/service provider quality. The successful candidate must have experience in a biotech or pharmaceutical GXP environment.

Responsibilities:
  • Execute vendor/service provider audits
  • Partner with vendors/service providers to establish relationships
  • Aide in the establishment and maintenance of policies and procedures for vendor/service provider management
  • Develop Audit Plans
  • Monitor metrics to ensure vendor/service provider performance is measurable
  • Maintain vendor/service provider data
  • Track vendor/service provider conformance to audit commitments and corrective and preventative actions
  • Review change notifications and determine impact to internal systems
  • 10-20% Travel

Requirements:
  • BS in a scientific discipline with at least 8 years’ experience in pharmaceutical / biotech industry within Quality Assurance
  • Preferably prior experience in GCP, GLP, GVP auditing
  • Outstanding communication skills (verbal and written)
  • Ability to manage multiple projects in a fast-paced environment
  • Familiarity with Veeva and SAP
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Advanced understanding of the job 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. Works on assignments requiring considerable judgement and initiative. Understands implications of work and makes recommendations for solutions

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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