Director of GCP Quality Assurance

$190000 - $210000 per annum
  1. Permanent
Cambridge, Massachusetts
  1. Quality Assurance, Quality Systems
Posted:24/11/2020
BBBH15499

This vacancy has now expired. Please see similar roles below...

Hobson Prior are currently recruiting for a Director of GCP Quality Assurance to join a medium-sized Biopharmaceutical organisation who are focused on developing T-cell therapies for the treatment of Cancer. This is a permanent position located in Cambridge, United States.

Job Responsibilities:

  • Accountable to provide quality oversight for all external clinical quality systems, including CROs, independent studies, investigator sites, central labs, non-clinical study laboratories and other significant partners supporting the company's clinical and pharmacovigilance programs.
  • To formulate a GCP Compliance strategy and providing Quality guidance for all development programs.
  • Responsible to execute and organise quality audits of CROs, clinical, data management/processing, and pharmacovigilance vendors and activities. Utilizing audit results to drive improvement and reduce risk to the organisations clinical trials.
  • You will be overseeing quality reviews of clinical and nonclinical study documents and regulatory submissions.
  • Be able to establish and implement clinical quality policies and procedures.
  • Managing Quality Agreements with CROs and clinical vendors.
  • Planning and overseeing day-to-day activities of the Quality function including management of consultants/auditors as needed to ensure project and business needs are met.
  • Providing input and support in partnership with teams across R&D and clinical operations.
  • Accountable to develop and oversee appropriate Quality metrics.
  • Reporting on the organisations compliance to senior management and advising them of critical quality and compliance related issues and corrective actions to mitigate quality and compliance risks.
  • Partaking in CMC and Core Program teams to strategize GCP quality planning and regulatory filings.

Key Skills:

  • Strong collaborative, influencing and interpersonal skills with excellent verbal, written and presentation skills with the ability to deal effectively across all levels of management.
  • You will be able to prioritize competing activities and manage resources and budget accordingly.
  • You will be able to maintain and create professional networks with stakeholders internally and externally.

Requirements:

  • Will need to require a BS in Chemistry, Pharmacy, Biology or a related life science. A Master's degree will be preferred.
  • You need a minimum of 8-15 years of experience within the Clinical quality function of the pharmaceutical/biotech industry.
  • Wide knowledge and experience of implementation of Quality Systems, PV, and cGCP Quality regulations for USA, EU and other global Health authorities. Experience in Pharmacovigilance strongly preferred.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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