GCP QA Operations Manager - Remote - new job in Richmond, US

GCP QA Operations Manager - Remote
  • $90 - $150 per Hour
    HOUR
  • Temporary
  • Richmond VA, US Richmond CHESTERFIELD US
Job Ref: JO000132527
Sector: Clinical
Sub-sector: Quality
Date Added: 21 September 2022

SRG is the leader in the life science human capital industry, and we apply specialized industry knowledge to a full spectrum of science, clinical, and engineering jobs and talent solutions. We recruit across the product life cycle,
covering scientific research and technology, clinical trials, manufacturing, and engineering disciplines. SRG creates world-class communities that empower individuals and businesses alike to shape tomorrow’s world.

Title: Global Quality, QA Clinical Operations Manager (Part Time)

Location: Remote

POSITION SUMMARY:

This position plays a lead role within GCP QA process, works closely across cross functional teams to ensure the R&D Quality Management System (QMS) results in clinical trials that meet global regulatory and business requirements. This position represents the company both internally and externally.

ESSENTIAL FUNCTIONS:

  • Support qualification, routine, and for-cause audits of Clinical Research Organizations (CRO), investigator sites, laboratory, and data management vendors as well as other clinical vendors to assess effectiveness of their QMS and compliance to approved clinical study protocols and contracts.
  • Ensure quality incidents are fully investigated, root cause analysis is defined and that CAPA has been implemented and monitored for effectiveness.
  • Evaluate audit, regulatory and industry trends to identify potential compliance risks and continuous improvement initiatives.
  • Advise Clinical operations team regarding aspects of GCP and compliance to standard operating procedures and regulatory requirements.
  • Review and approve clinical process deviations for compliance and completeness.
  • Serve as a key point of contact for quality assurance questions/issues for clinical programs, studies and vendors.
  • Conduct review of clinical Standard Operation Procedures (SOPs) and serve as first line quality approver.
  • Conduct site and sponsor inspection readiness preparation, including the identification of key risks and mitigation strategies, coordinating site inspection management activities, and facilitating inspection responses as appropriate.

MINIMUM QUALIFICATIONS:

Education and Experience:

  • Bachelor of Science or Bachelor of Arts degree in a life science. Post graduate degree is preferred.
  • Proven track record of GCP QA operations experience in a regulated industry such as FDA, pharmaceutical or biotech.
  • Ability to travel with adequate notification approximately 20% of working hours is required.
  • Thorough understanding of regulatory requirements for the conduct of clinical trials for drug product, devices or combination products.
  • GCP audit and regulatory inspection experience in North America and EU preferred.

Impellam Group and its brands are equal opportunity employers committed to diversity and inclusion.
Impellam Group is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

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SRGTalent https://www.srgtalent.com https://www.srgtalent.com/-/media/srg/1---new-website/logos/website-logo-all-padding-removed.png
30/09/2022 12:00:00
USD 90.00 150.00 Hour
Contact Consultant:
Brian Houston

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