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Director Quality Assurance, GLP

Employer
Proclinical Staffing
Location
Pennsylvania, USA, Philadelphia
Salary
Highly Competitive Salary
Start date
28 Nov 2022
Closing date
12 Dec 2022

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

Job Details

Proclinical is seeking a Director Quality Assurance, GLP for an innovative gene therapy organization located in Philadelphia, PA. In this position, your primary responsibility will be to manage a GLP Lab, including Good Laboratory Practice / Good Manufacturing Practice (GLP/GMP) supporting the development, manufacture, and testing of viral vectors for clinical trials. Other responsibilities include:

Job Responsibility:

  • Provide support for a GLP non-human primate (NHP) facility and GLP studies performed in a partial-GLP rodent facility, in addition to overall QAU support for GLP studies performed in the labs (eg, analyses for IND-enabling studies).
  • Support the comparable GMP production activities related to GLP toxicology lot production and technical transfer activities as it relates to clinical batch release testing conducted to support the clinical CMO.
  • Provide Quality Assurance support to the research-based portion, in terms of SOP management, training, document management and archiving, and audit support.
  • Interact with the senior management staff and directors of the other functional groups within GTP and will be responsible for ensuring GxP compliance across identified groups within the GTP.
  • Ensure Quality Assurance oversight, manage and coordinate, and ensure that all cell and gene therapy products comply with the requirements of FDA and other health authority or regulatory/accreditation bodies.

Skills and Requirements:

  • A Master's degree in life sciences and 5-7 years of experience in a quality assurance role or an equivalent combination of education and experience is required.
  • Experience effectively managing a team, including work flow management & performance management.
  • Experience working in GLP/GMP environment and strong knowledge of GLP/GMP's required
  • Experience in cell and gene therapy is strongly preferred.
  • Demonstrated ability to work collaboratively, multi-task, and prioritize in a fast-paced environment a must.
  • Strong analytical skills and attention to details required.
  • Must have demonstrated experience meeting critical deadlines.
  • Experience with Microsoft word, excel and access required. Proficiency with access databases preferred.

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at (+1) 267-297-3280 or b.copeland@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-BC1

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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