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Job Details

Sr./Manager GCP

Company: EPM Scientific
Location: Fremont
Reference: MLBY
Closing Date: 28 Nov 17
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

Sr./Manager GCP-Fremont-Six-month Contract-to-HireEPM Scientific is partnering with a rapidly growing company in the Biotech industry.  Due to recent growth in the company and the...

Requirements:

Sr./Manager GCP-Fremont-Six-month Contract-to-Hire
EPM Scientific is partnering with a rapidly growing company in the Biotech industry.  Due to recent growth in the company and the start of further projects, we are looking for a Sr./Manager GCP for an initial six-month contract to Hire.

This is an office based role based in Fremont.

This Sr./Manager GCP position will

  • Manage the GCP audit program and provide routine reporting of progress to plan.
  • Conduct assignments for GCP audits of CROs, Clinical Labs, Phase I Units, Clinical Investigator sites, and internal operations.
  • Lead CQA audit activities to ensure that studies are conducted in accordance with regulatory requirements, internal procedures, and study protocols and procedures.
  • Provide administrative support including; maintaining audit logs, generating reports, creating templates and others as needed.
  • Organize and conduct both internal and external quality assurance audits of systems, clinical investigative site audits, procedures, and controls employed in the design, conduct, and analysis of clinical trials.
  • Plans schedule, and conduct clinical vendor audits.
  • Review, revise, update and maintain Clinical Approved Vendor List and manages updates to the clinical vendor audit database.
  • Support clinical teams in gathering and reporting various performance metrics.
  • Keep abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.
  • Communicate observations to clinical program managers and investigators.
  • Document audit observations; evaluate impact and responses to audit findings and ensure the appropriate corrective actions are completed
  • Assist clinical QA Management with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives.




The ideal Sr./Manager GCP would have:

  • B.S. in Life Sciences. 5+ years progressive experience in pharmaceutical industry in Clinical Development & Quality
  • 5+ years experience in Biotech/Pharma CQA role with at least 3 years CQA auditing experience.
  • Regulatory document/filing review experience
  • Experience with interacting with third parties (e.g., contract service providers).
  • Experience in managing concurrent complex projects/programs (e.g. process improvement initiatives, clinical projects).
  • Direct experience in GCP compliant quality systems and processes.
  • Ability to interpret and relate Quality standards for implementation and review.
  • Ability to effectively communicate issues across departments and conducting presentations of technical information concerning specific projects or timelines.
  • Substantial leadership ability, able to lead a cooperative effort and strong resource organization
  • Ability to make and prioritize process and resource decisions based on overall team needs.
  • Ability to work in a fast-paced, dynamic environment.
  • Extensive computer skills, including Microsoft Suite, eTMF


If you are an independent contractor, looking for you first contract/temp position or interested in working with a leading Biotech company, please send your resume to freelancejobs@epmscientific.com.

Apply for this job: Sr./Manager GCP

Contact Information:

Address:  Head Office
Ground Floor 21 Lombard Street London
EC3V 9AH
England
Tel:  +44 (0)20 3758 8855
Website:  Visit Our Web Site

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