date posted: Saturday, September 12, 2020
experience: 5 Years
job type: Permanent
industry: Professional, Scientific, and Technical Services
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
location: Cambridge, Massachusetts
job type: Permanent
salary: $128,000 - 140,000 per year
work hours: 9 to 5
Participate in the execution of GCP/GLP/GPV QA strategies for
the support of global clinical trials, and non-clinical
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
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
Contribute in the continuing development of a quality
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
Auditing and audit report writing skills in a sound and factual
Ability to manage multiple projects in a fast-paced
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.
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