Senior Director Of Quality And Regulatory Affairs

Goodall Brazier is working with an exciting CDMO, that specializes in the cell and gene therapy space. They are looking for an ambitious Senior Director of Quality and Reg Affairs candidate, that has the passion and growth to develop into their VP!

This role will be a crucial part of the company and does require the right candidate to be on-site.

The role responsibilities:

· Has decision-making authority for any Quality issues; informs Site Quality Head of critical issues in a timely manner.

· Applies biologics manufacturing experience to ensure that operations meet customer and regulatory expectations and requirements for manufacturing at all clinical and/or phases.

· Leads preparations for regulatory inspections and inspection readiness.

· On-site or remote/virtual auditing to support approval of new suppliers; on-going qualification of existing suppliers; or to investigate specific events involving GCP and GLP compliance (‘for cause’ audits). Review and follow up on audit responses from these providers to ensure appropriate corrective and preventive actions (CAPA) are assigned and executed.

· Develops a Quality culture on site, such that the Quality team provides leadership and coaching to ensure GMP best practices are embedded throughout the site.

· Ensures that the site complies with all applicable laws and regulations relative to current Good Manufacturing Practices.

· Manages the Quality budget, ensuring well-defined resource modeling.

· Determine, establish, and maintain comprehensive systems that document and monitor GMP Quality and ISO standards that meet corporate, regulatory, and customer requirements.

· Reporting of Critical Quality Systems to Executive Leadership

· Manages the Quality Assurance team against the site Quality strategy objectives.

· Works cross-functionally to ensure Quality standards are upheld and new processes meet Regulatory Requirements.

Works with Clients to ensure proper communication on the release of products and resolving any Quality issues that arise during production.

Requirements:

• 12+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing, or laboratory environment. 7-10 years experience in Quality Management.
• Experience leading a Quality Dept at a CDMO (preferred)
• Experience interacting with FDA and other global agencies
• Regulatory Knowledge CBER, CDER, CDRH, and other global agencies
• Expert knowledge of GMP, FDA, and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
• Ability to prepare audit reports, quality agreements, standard operating procedures, and CAPA reports in accordance with companies Quality System requirements