Clinical Quality Manager (GCP)
Company: Beacon Hill Staffing Group - Pharma
Posted on: June 18, 2019
Plan and lead GCP audits (international and domestic), including
clinical investigator sites, contract clinical laboratories, and
CROs to determine compliance status and identify compliance risks.
Assess GCP compliance risk areas and develop and implement risk
mitigation measures. Ensure compliance with companys procedures and
regulatory requirements. Conduct QA reviews of project-related
Clinical Development essential documents (e.g. protocols,
amendments, case report forms, tables and listings, informed
consents, investigator brochures, and Clinical Study Reports).
Review and provide input in to non-clinical documentation (e.g.
protocols, study reports). Facilitate GCP training of functional
areas and develop appropriate training for personnel involved in
the execution of clinical trials and nonclinical studies.
Participate in the evaluation and selection of CROs and other
clinical and nonclinical service providers. Provide guidance,
interpretation and information on GCP regulations, standards and
quality systems. Develop and implement standards, policies and
procedures for GCP regulatory compliance. Develop and measure
quality metrics to drive consistent quality standards relating to
GCP activities. Experience, Education and Specialized Knowledge and
Skills Must thrive working in a fast-paced, innovative environment
while remaining flexible, proactive, resourceful and efficient.
Excellent interpersonal skills, ability to develop important
relationships with key stakeholders, good conflict management and
negotiation skills, ability to analyze complex issues to develop
relevant and realistic plans, programs and recommendations.
Demonstrated ability to translate strategy into action; excellent
analytical skills and an ability to communicate complex issues in a
simple way and to orchestrate plans to resolve issues and mitigate
risks. Masters Degree preferred with minimal 10 years experience in
Biotech or Pharma and 5+ years experience in Quality Systems
related to GCP. Strong analytic skills with practical knowledge of
how to identify key performance quality metrics to set targets for
maintaining a state of compliance while identifying areas for
improvement. Extensive experience auditing clinical CROs, clinical
sites and investigator sites. Understanding of domestic and
international regulatory requirements. Outstanding communication
skills (interpersonal, verbal and written). Proven track record of
industry success. Strong leadership and management skills.
Excellent teamwork and collaboration skills. Embrace our core
values: Put People First, Do Big, Be Accountable, Grow through
Learning and Change, and Work Fun.
Keywords: Beacon Hill Staffing Group - Pharma, Greenville , Clinical Quality Manager (GCP), Executive , Durham, North Carolina
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