Head Of Quality Operations

Head, Quality Assurance

Working Situation: Remote

Level: Director/ Executive

A rapidly growing Large Biotech is looking for a highly motivated and experienced Head of QA in biologics who is dedicated to responsibilities include developing quality standards, conducting tests and identifying issues in the production of our products or services. Ultimately, you will work with a team to ensure our final products meet standards across the board. The perfect candidate would be willing to work hands-on to ensure compliance and support a quality-oriented culture throughout the site. If you see yourself being a leader of innovation and discovery this opportunity is for you.

The Head of QA will be responsible for…

• Managing a growing team of 20 to 50 technicians & managers while continuing to develop positive company culture.
• Acting as a strong leader with a passion for growth and success for QA teams
• Manage external client relationships related to quality assurance and ensure their needs are met.
• Have access to the most new and exciting novel therapeutics in the space while partnering with fellow strong leadership to run successful quality oversight.
• Leads Regulatory/FDA inspections on behalf of their assigned facility by providing information or expediting/obtaining information required by the inspectors. Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required.
• Develop and maintain strong relationships with internal stakeholders, including research and development, manufacturing, and clinical operations teams, to ensure quality standards are met throughout the product life cycle.

The Head of QA should have the following qualifications….

• Bachelor's degree in the Life Sciences field or a related field. M.S. preferred with a minimum of 10 years in QA with at least 8 years in management.
• Strong understanding of federal regulations and company procedures with an ability to effectively communicate as they apply to biologic drugs.
• Experience in managing external client relationships and working with CROs/CMOs.
• Strong leadership and organizational skills, with experience managing teams of 10 or more people.
• Background in Biologics or Cell & Gene Therapy.

Benefits

• Long term incentives
• Competitive Health Insurance
• Generous PTO Package
• 401k Match
• Competitive Salary and Bonus

If you are interested in the role of Head of QA, don’t hesitate to apply today!