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Sr. Manager/AD, GCP/GLP/GVP Compliance

Cambridge, MA 02139

Posted: 11/20/2019 Employment Type: Direct Hire Job Category: Clinical: Quality Job Number: 2478

Job Description


Reporting to the Sr. Director of GCP/GLP/GVP Quality Assurance, the Sr. Manager / Associate Director of GCP/GLP/GVP Quality Assurance will (i) be a key contributor in growing and shaping our client’ s newly-established GCP/GLP/GVP Function, (ii) be responsible for helping to establish our client' s Quality Management System for the areas of GCP, GLP and GVP, (iii) and aid in the establishment of Annual Audit Plans in support of clinical studies, analytical studies, etc., ensuring compliance with Health Authorities Regulations (e.g., FDA, EMA, etc.). The appointee will also be responsible to partner with study teams to create a quality culture and help reach a sustained state of inspection readiness.

Responsibilities:
  • Participate in the development of GCP/GLP/GPV QA strategies for the support of global clinical trials, and non-clinical activities.
  • Establish and maintain policies and procedures for the GCP/GLP/GPV QA function, as well as provide guidance/review/approval of policies and procedures within these functional areas.
  • Partner closely with members of the Clinical and Research Development groups to support the successful and compliant execution of clinical and non-clinical studies.
  • Develop and/or provide input in the development of Annual Audit Plans (GCP/GLP and GPV), and study-specific audit plans.
  • Plan, execute and report audits, as necessary, and work with client staff to ensure the proposed corrective actions received from the auditees are appropriate.
  • Help train/prepare employees for regulatory inspections (Sponsor inspections) and/or clinical and non-clinical sites/vendors.
  • Help host regulatory inspections, as necessary, and provide input and review of responses to regulatory agency questions resulting from these inspections.
  • Contribute in the continuing development of a quality culture.
  • 10-20% Travel Required

Requirements:
  • BS/BA, MS or PhD and a minimum of 12, 10, 9 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.
  • Working knowledge of relevant FDA, EU, ICH GCP guidelines, and GCP and/or GLP regulations.
  • Knowledge of relevant FDA, EU, ICH Pharmacovigilance guidelines and regulations an advantage.
  • Experience working with CROs, vendors, and relationship management preferred.
  • Excellent auditing skills and ability to communicate significant observations to Principal Investigators, Senior Scientists, etc., in a sound and factual manner.
  • Ability to manage multiple projects in a fast-paced environment.
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

Meet Your Recruiter

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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