The Director / Sr. Director of Quality Assurance will be responsible for the overall quality assurance for the company’s GMP activities. Develops, implements, prioritizes, and communicates the company’s GMP quality strategy and its GMP quality programs. Promotes recognition of company GMP quality programs among customers and develops and implements employee communications and training programs in connection with the company’s GMP quality objectives, strategies, and processes. Responsible for translating the company’s GMP quality strategy into tactical policies, processes and procedures to meet global regulatory, medical/health and legislative standards. In that role the incumbent will be responsible for the following:
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Manage and implement GMP Quality systems including oversight and management of SOPs, Training and including oversight, management and qualification of all vendors. This responsibility will include, where appropriate, implementation and maintenance of a suitable software system to support quality systems related activities.
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 GMP requirements.
Direct the review and release of all products for which the sponsor holds the IND/NDA or equivalent global license application (investigational and commercial). Per contractual agreement the incumbent may also provide release of product for a license partner.
Develop an Inspection Readiness Model. Deliver training and lead the process for Regulatory Inspections.
Provide post-regulatory agency inspection support and follow-up as required.
Perform or oversee internal and external audits ensuring compliance with company policies/procedures and applicable regulations
Review and approve audit reports and Corrective and Preventive Actions (CAPAs)
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.
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.
Establish requirements for trend reports and summaries for routine Quality Management Review.
Communicate metrics, trends, and data summaries to senior management using a variety of media: intranet, reports, and presentations.
Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements for best practices.
Provide back-up and signing authority to the VP of Quality as required.
Conduct all functions associated with recruitment and hiring process for Quality Assurance positions (full-time, part-time, temp, Limited Term)
Provide training, guidance and mentoring of staff with various experience levels and capabilities to develop new leaders, individual contributors, and technical experts.
Qualifications
Academic & Professional Qualifications:
BA/BS degree required. Advanced degree preferred.
Experience:
Minimum of 10-15 years’ relevant experience within the biotech or pharmaceutical industry and minimum of 5 years of experience at a senior management level. Candidate must have a proven track record working in a GMP compliant environment. Demonstrated ability to lead GMP operations. Applicant should also have experience in participating in internal audits and regulatory agency inspections.
Other Skills & Abilities:
Excellent written and verbal communication skills.
Travel Requirements:
This position may involve limited travel, < than 10% Work Arrangements: This position will be based at our corporate headquarters (La Jolla, CA)
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