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Director of Clinical Quality Assurance (GCP)

Industry: Life Sciences

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Director of Clinical Quality Assurance (GCP)

Our client, located in the Philadelphia area, is currently in search of a clinical quality assurance professional to join their team. This is a great opportunity to contribute to the growth of an emerging pharmaceutical company.

Job Responsibilities:

  • Responsible for the development, implementation and maintenance of global quality systems including writing and review of company standard operating procedures and policies for compliance with national and international regulations and guidelines.
  • Oversees the management of internal and external audits (internal systems, trial master file, investigator sites, clinical service providers) to assess the accuracy and quality of scientific data collected, and to determine the level of compliance with applicable regulations.
  • Oversees the documentation of audit observations and recommendations for corrective and preventive action Plans.
  • Evaluates responses to audit reports and ensures timely and appropriate implementation of corrective actions.
  • Identifies key areas of regulatory risk and suggests potential resolutions.
  • Identifies and implements quality improvements that address weaknesses or exposures revealed through QA activities. Identifies ways to improve compliance with regulations and company policies and procedures.
  • Supports the preparation, coordination and management of Regulatory Agency inspections at clinical sites and company office.
  • Travel 25 to 30% depending upon project status.

Job Requirements:

  • Bachelors Degree (BA/BS) in scientifically related field such as chemistry, pharmacy, biochemistry, or biology
  • 5-10 years of Quality experience in the Pharmaceutical Industry focused on GCP compliance, including auditing of clinical sites, quality systems, clinical trial master files, CRO qualification, site management organization, and data management for compliance to applicable standards and regulations.
  • Previous direct experience with inspections, audit procedures and reporting, and investigations is required.
  • Demonstrated experience of managing Quality deliverables across a range of Contracted Vendors is required
  • Must have in-depth practical knowledge of FDA and ICH regulations and guidelines pertaining to clinical quality and compliance.

Location: Philadelphia, PA & Princeton, NJ

Compensation:

152K base salary, (Compensation commensurate with experience and salary history), annual target bonus, stock options and benefits package.            

For confidential consideration, please forward your resume in a Word document to
bthornton@kleinhersh.com.

Visit www.kleinhersh.com to view other job opportunities available through our company.

For additional information about this job, please contact: bthornton@kleinhersh.com