Director, Head Of Quality Compliance

Director, Head of Quality Compliance – Competitive Salary + Benefits

Suitable for: Director of QA, Director of Quality Compliance, Director Commercial QA, Associate Director QA Compliance

Are you looking for the next step in your Quality Assurance career in a fast-paced environment? If so come and join us to help the development of the life sciences industry, developing innovative ways to treat patients.

We are offering a permanent position as a Director, head of Quality Compliance in a meaningful environment, with a competitive salary package, including other benefits.

Please contact Hugo Poitel at +1 (646) 582-3683 or by email at [email protected] for more information about this exciting opportunity

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

• Implementing and developing QMS and SOPs - includes SOPs, Deviations, Audits, KPIs, CAPAs…
• Tech transfer to China so will be working with the Chinese teams
• Main POC with the FDA, management of external vendors
• Hiring and developing the QA function team
• Establishing the Quality department on a new site

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

• Experience with large molecules, biologics (ideally experience in monoclonal antibodies)
• BPDR - Biological Product Deviation Report experience
• Strong Line-management experience
• Commercial Quality manufacturing experience
• FDA expert - will be dealing with the FDA often in this role

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, please apply below. This role is being managed by Hugo Poitel at Meet, please contact me at +1 (646) 582-3683 or directly by email at [email protected] to confidentially discuss it.