Director, Head Of Qa

Director, Head of QA Compliance

Suitable for: Associate Director or Director of Quality Assurance

Are you looking to step into the next level the in your career at a global Biotech? If so you're in luck as we're recruiting for a Director/Head of QA Compliance. My Client is a stable yet dynamic and world leading Biotech specialising in Oncology and we are offering a highly competitive salary package on top of several other benefits!

This role is an excellent opportunity to be one of the most senior QA members, whilst taking ownership of providing oversight of GMP requirements across development and clinical stages and building a team.

Please get in touch with Simba Nyakupinda on + 1 (656)582-3702 or email [email protected] for more details about this opportunity.

For this exciting Director of Quality Assurance role, your main duties include, but are not to be restricted to, the following duties:

• Managing and conducting external audits of CMOs
• Building a team of Quality professionals
• Providing oversight of GMP with development stages and clinical phases.
• Review and approve manufacturing documents including master and executed batch records, deviations, change controls, protocols, and associated reports.
• Assess emerging issues from quality and GMP perspectives and provide direction to CMC and other key stakeholders.
• Act as a QA lead and manage relationships with CMOs

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

• FDA Experience
• Manufacturing (drug substance/API, drug product, packaging, and labelling).
• Experience managing and conducting external audits of CMOs
• Experience working with external vendors and suppliers
• Must have experience working in cross-functional teams including, CMC, analytical, supply chain, and regulatory affairs.
• Biologics experience and experience authoring Biological Product Deviation Report (BPDR)
• 10 years of experience in a GMP development environment.
• A Bachelor of Science in a scientific discipline

MEDICAL REQUIREMENTS

COVID-19 vaccine required to come on-site; Individuals seeking an exemption from this requirement for medical or religious reasons should reach for an accommodation

Interested in finding out more?

The full job description is available post-application so please apply below. This role is being managed by Simba Nyakupinda at Meet. Please contact me at +1 (646) 582-3704 or directly by email at [email protected] to discuss in confidence.