The Director / Sr. Director of Quality Assurance will be responsible for the overall quality assurance for the company’s GxP activities. Develops, implements, prioritizes, and communicates the company’s GxP quality strategy and its GxP quality programs. Responsible for translating the company’s GxP quality strategy into tactical policies, processes, and procedures to meet global regulatory, medical/health and legislative standards.
- BA/BS degree in technical discipline (Chemistry/Microbiology/Engineering or similar) required; advanced degree preferred.
- Minimum of 10-15 years’ relevant experience within the biotech or pharmaceutical industry.
- Minimum of 5 years of experience in a leadership position with management experience required.
- Candidate must have a proven track record working in a GxP compliant environment. Demonstrated ability to lead GxP operations. Applicant should also have experience in participating in internal audits and regulatory agency inspections.
- Manage and implement GxP Quality systems including oversight and management of SOPs, Training and including oversight, management, and qualification of all vendors.
- Oversee GMP operations at CMOs including quality review of batch records, analytical data, and lot disposition activities of API, Bulk drug product, packaged and labeled drug products to support clinical and commercial.
- Collaborate and establish procedures with technical operations and manufacturing staff to ensure that clinical supply and commercial manufacturing activities are conducted in compliance with applicable GCP/GMP requirements.
- Direct the review and release of all products for which the sponsor holds the IND or equivalent investigational application.
- Experience with biologic/vaccine API and DP processes in a contract manufacturing and testing environment.
- Review and approve audit reports and Corrective and Preventive Actions (CAPAs)
- Collaborate and resolve complex issues with regards to supplier performance. Assist in performing root cause analysis, risk assessments and identify appropriate corrective action plans. Effectively negotiate difficult conversations on a routine basis.
- Oversees the technical review of data and documentation, ensuring that they are maintained in compliance with FDA regulations, global regulations and internal directives.
- Develop and implement strategies for Supplier Quality Management, streamline processes and effectively utilize resources.
- Perform or oversee internal and external audits ensuring compliance with company policies/procedures and applicable regulations.
- Develop and train personnel for Inspection Readiness. Provide post-regulatory agency inspection support and follow-up as required.
- Provide training, guidance and mentoring of staff with various experience levels and capabilities to develop new leaders, individual contributors, and technical experts.