Quality Assurance Manager

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Quality Assurance Manager

Location: New Jersey, USA

Salary and package: Available upon enquiry

 

Our client is a rapidly growing and truly global Biotech business that is rivalling some of the industry leaders in the development and manufacturing of cell therapy products.

Due to continued growth at their site in New Jersey, an opportunity has arisen for a high-calibre individual to join as Quality Assurance Manager and lead their QA unit. Our client is keen to find a dynamic leader, capable of mentoring and developing a large QA team.

The ideal candidate will be able to implement ongoing quality improvement processes working with interdepartmental teams, ultimately ensuring the safe release of cellular products. The QA Manager will delegate responsibilities to direct reports to achieve the requisite business needs while providing ongoing support to Manufacturing processes.

 

The main responsibilities for this role include:

  • Ensuring compliance with applicable cGMP and GTP regulations and company and client SOPs
  • Ensuring the safe release of cellular products in accordance with company and/or client procedures and requirements
  • Mentoring, developing and leading Quality Assurance team
  • Developing and managing quality assurance metrics for performance improvement of all teams
  • Authoring and reviewing relevant SOPs, validation and other documents
  • Effectively hosting client audits and providing on-time response to audit findings
  • Interfacing with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented
  • Authoring and reviewing relevant SOPs, validation and other documents
  • Providing input based on knowledge and experience of quality systems and procedures
  • Providing support to manufacturing for investigations of deviations, validations, and development of specifications

 

To be considered for this role and to succeed in this position, you will need:

  • Minimum 5-10 years of related experience in the pharmaceutical or biologics industry
  • Strong collaborative and influencing skills
  • Ability to work well in a cross-functional matrix environment
  • Significant QA team leadership experience
  • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)
  • Sound knowledge of aseptic processing and supporting technologies
  • Analytical and technical troubleshooting skills
  • Strong team-oriented interpersonal skills are essential

 

If you're interested in this fantastic leadership role, we want to hear from you - please apply for the role below or get in touch:


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