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Manager, GCP/GLP/GVP, QA

Company: Randstad USA
Location: Cambridge
Posted on: September 17, 2020

Job Description:

date posted: Saturday, September 12, 2020

experience: 5 Years

job type: Permanent

industry: Professional, Scientific, and Technical Services

job summary:

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

location: Cambridge, Massachusetts

job type: Permanent

salary: $128,000 - 140,000 per year

work hours: 9 to 5

education: Bachelors

responsibilities:

Participate in the execution 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 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.

Provide input in the development of Annual Audit Plans (GCP/GLP and GPV), study-specific audit plans, and vendor-specific audit plans.

Plan, execute and report audits, as necessary, and work with 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 for responses to regulatory agency questions resulting from these inspections.

Contribute in the continuing development of a quality culture

qualifications:

Bachelor's Degree with a minimum of 8 years' experience in Biotech, Pharma or Clinical Research Organization (or a Master's degree with 5+ years' experience).

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.

Auditing and audit report writing skills 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.

skills: GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Randstad USA, Registered office:? One Overton Park, 3625 Cumberland Blvd SE, Atlanta, GA 30339.

RANDSTAD, HUMAN FORWARD and SHAPING THE WORLD OF WORK are registered trademarks of Randstad N.V.

https://play.vidyard.com/UFE6iGFMt3jTZh9ES1GPbS.jpg?

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Keywords: Randstad USA, Cambridge , Manager, GCP/GLP/GVP, QA, Other , Cambridge, Massachusetts

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