Associate Director, Clinical Quality Assurance, Pennsylvania

  • Salary: Up to $247K
  • REF Number: 00049431
  • Consultant: Jim Gleeson
  • Contact: 01438 842973
  • Date Published: 07.01.2021
  • Sector: Non-Specific
  • Location: Pennsylvania, London, USA (East Coast)
  • Discipline: Clinical Quality Assurance

Jim Gleeson is recruiting for an Associate Director, Clinical Quality Assurance to join a clinical phase biotechnology company developing gene therapy treatments. The role will be based at their Pennsylvania office, but with significant home working.Salary:

Base salary up to £247K plus excellent benefits.

RESPONSIBILITIES:

As Associate Director, Clinical Quality Assurance you will ensure full compliance with ICH-GCP, company SOPs and applicable regulatory guidelines across all clinical development activities.

Key duties will include:

  • Establishing and managing a Quality System as it relates to GCP including writing, reviewing, approving and/or maintaining Standard Operating Procedures and other applicable clinical documentation.
  • Leading and driving GCP Quality and compliance related activities for the company to adherence to Good Clinical Practice (GCP) in conduct of clinical trials, the quality and integrity of generated data.
  • Ensuring compliance of activities performed by clinical vendors or suppliers (i.e. Audit adherence; Quality Agreements).
  • Ensuring effective Corrective and Preventive Actions are implemented.
  • Establishing audit plans and conducting audits (internal, vendors, clinical sites, suppliers, etc). Completing reporting of audit results in a timely manner.
  • Acting as a strong technical resource and being called upon to resolve GCP issues based on knowledge of relevant SOPs and GCP regulations and guidelines, as well as local regulations.

QUALIFICATIONS:

As Associate Director, Clinical Quality Assurance you will require:

  • A relevant Life Science degree and extensive, industry based experience of GCP QA.
  • Expert knowledge of pharmaceutical regulations, standards,and current industry regulatory practices
  • Proven ability to thrive in a collaborative team environment: strong oral and written communication skills, interpersonal skills and a helpful team spirit.
  • Proven negotiation skills and experience in managing regulatory authority audits.
  • Gene therapy experience will be advantageous

Apply:

Entitlement to work in the US is essential. For more information please contact Jim Gleeson on +44 (0)1438 842973 or email jgleeson@ckclinical.co.uk. Please quote reference 49431 in all correspondence.

CLINGEN

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