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Director of GCP Quality Assurance

Employer
Hobson Prior
Location
USA, Cambridge, Massachusetts
Salary
£155833.50 - £172237.03 per annum
Start date
24 Nov 2020
Closing date
8 Dec 2020

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

Job Details

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.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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