Director of Clinical QA

111837
  • 175000 USD - 210000 USD
  • Malvern, United States
  • Permanent

Director of Clinical Quality Assurance - Remote


Suitable for: Senior QA Manager, Associate Director of QA or Director of QA

Are you looking to start a role with a world leading and innovative Clinical Biopharma company based on the East Coast where you can grow your career? If so, get in touch as we are recruiting for a permanent GCP Director of Quality Assurance.

My client are a Clinical Biopharma company with broad product pipeline from pre-clinical to phase ii covering therapeutic areas including auto-immune diseases, arthritis, dermatitis, Oncology and Bowel diseases.

This role is an excellent opportunity to be the most senior QA member and will give you autonomy in the clinical development program, managing relationships with the FDA , regulatory authorities and CROs. It will also be responsible for leading a small team.

For this role, they are offering a highly competitive salary, remote working flexibility, excellent bonus and a comprehensive benefits package.

Please get in touch with Simba Nyakupinda on (656)582-3702 or email simba@peoplewithchemistry.com for more details about this opportunity.

ROLE RESPONSIBILITIES:

In this exciting Director of QA role your main duties include, but are not to be restricted to, the following duties:

  • To be responsible of the Clinical development program by collaborating with Clinical Operations, CMC and other departments involved in the clinical development and clinical trial process to ensure that clinical objectives are met within the desired project timeframe

  • Providing oversight and guidance on GCP regulations and standards to various functional areas

  • Plan and lead audits, including clinical investigator site, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks

  • Participate in the evaluation and selection of CROs and other clinical and nonclinical service providers

  • Assess GCP compliance risk areas and develop and implement risk mitigation measures.

SKILLS DESIRED:

To be successful in this Director role, your experience will need to include:

  • BSc (minimum) in Life Sciences related relevant discipline 

  • 10-12 years' experience in a clinical QA pharmaceutical or Biotech environment 

  • Ability to interpret and apply regulatory expectations for GCP

  • Previous experience leading inspections and audits for regulatory purposes 

  • Experience working with and managing clinical vendors (CROs), clinical site personnel and contractors/consultants

  • Experience working with Clinical Operations to facilitate management of clinical sites and CROs

If you are interested in finding out more, the full job description and company details are available when you apply, please apply below. This role is being managed by Simba Nyakupinda at Meet, please call me on (646)582-3702 or e-mail me directly at simba@peoplewithchemistry.com to discuss in confidence.

Apply for this role

Not registered? Create your account or if you already have an account? Sign in here

Meet Recruitment 2022. Meet Recruitment Ltd., Meet Recruitment Inc. and Meet Personalberatung GmbH are all subsidiaries of Meet Group (No. 13556131) a company registered in England and Wales at Irongate House, 22-30 Dukes Place, London, EC3A 7LP.
Site by Venn