GLP Quality Assurance Director

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Director, GLP Quality Assurance Unit plays a vital role in the overall operations of the advanced laboratories facility, with a primary responsibility to lead and oversee the Quality Assurance Unit. This role reports directly to the acting Chief Operating Officer (testing facility management and institutional official) and provides independent oversight of all aspects of nonclinical studies, particularly those being conducted under Good Laboratory Practices (GLP).

This role is expected to act as a thought partner, working with other leadership members to assure that operations in all departments run smoothly and maintain compliance with relevant regulations, including those originating from the FDA, the USDA, or other regulatory bodies.

This leader fosters strong collaboration with both senior leadership and other facility staff, offers balanced & objective quality counsel, and has a proven track record of building or maintaining GLP compliant Quality Assurance Units within research organizations.

Responsibilities

• Assuring leaders, study sponsors, and regulatory inspectors that facilities, personnel, practices, and records are in compliance with all applicable regulations.
• Ensuring a complete portfolio of GLP policies, procedures, and work practices are established and consistently performed across departments.
• Providing strategic direction to leadership through goal alignment, proposing continuous improvement initiatives, and educating the organization on best-in-class practices.
• Assume ownership of all documents and reports produced by the team.
• Analyze complex situations and effectively communicate situations/issues, along with potential recommendations, to various functional groups where there is no precedent.
• Remain objective/autonomous in implementing the Quality Assurance Unit program, while at the same time taking ownership and proactively working with the rest of the team to achieve the desired quality objectives.
• Communicate critical risks to senior leadership.
• Ensure proper root cause analysis and strong Corrective and Preventative Actions (CAPAs) are implemented for non-compliance(s).
• Support investigational new drug applications and related correspondence from regulatory authorities.
• Serve as coach and mentor to team members.
• Provide scientific leadership to the QA team, assume accountability for successful regulatory body inspection readiness and leading inspections, maintain complete separation and independence from personnel engaged in the direction and conduct of a study, and reviews final study reports to assure that the reports accurately describe the methods and standard operating procedures.
• Responsible for ensuring that the responsibilities and procedures applicable to the Quality Assurance Unit, the records maintained by the Quality Assurance Unit, and the method of indexing such records are in writing and are maintained in accordance with the regulations while collaborating with internal departments on strategy and implementation of quality principles and regulatory requirements.

Requirements

• Ten (10) years of experience in GLP environment.
• Five (5) years of GLP quality assurance experience.
• Two (2) years of managerial or supervisory experience.
• Bachelor's Degree
• Preferred: (DVM, PhD, MD) in pharmaceutical, biological, or chemical sciences.

Preferred Experience:

• Animal clinical trial facility Quality Management (rodent to non-human primates)
• Experience with 21CFR58 GLP regulations and animal clinical trials
• Experience with IACUC (Institutional Animal Care Committees) requirements
• Experience in AALCA (Association for Assessment of Laboratory Animal Care) quality systems
• Experience with OLAW (Office of Animal Welfare) requirements.
• Quality systems for GLP veterinary care, animal husbandry, enrichment, nutrition.
• GLP Pathology and Necropsy laboratory settings and testing (Animal blood plasma testing, ELISA testing).