The successful candidate will be responsible for the leading the QA department and strategy at Leap including the maintenance and expansion of the Leap GxP quality systems and inspectional readiness activities. This includes business elements covering current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), as well as Good Pharmacovigilance Practice (GVP). Senior Director will collaborate with a cross functional team providing oversight to external vendors to ensure best GxP practices are implemented and followed internally Leap and at contract service providers including manufacturing organizations, testing laboratories, clinical research organizations.
Specific Responsibilities Include:
- Lead the continued development of the GxP quality infrastructure to support Leap through Phase 3 and commercial/launch using external contract manufacturing and testing laboratories.
- Direct and manage internal eQMS document control systems.
- Direct and manage Leap’s vendor qualification and audit programs.
- Manage and mentor existing QA personnel and plan for the growth of the department and quality program.
- Perform quality assurance activities associated with cGMP manufacturing, investigations, change control, complaint investigations, and documentation.
- Participate in batch release including the review of batch records, QC testing, SOPs, and other batch related documentation and lot release data.
- Provide GMP oversight and drive the resolution of investigations, deviations, out-of-specification/out-of-trend, change control, and CAPAs at contract sites.
- Contribute to commercial readiness preparation internally and at GMP vendors.
- Provide quality oversight of labeling and packaging in support of clinical supply operations.
- Ensure that the appropriate internal Standard Operating Procedures are written in accordance with regulatory requirements and global industry standards/expectations.
- Represent QA on applicable internal and external project management teams.
- Lead training and implementation of GXP procedures and quality systems.
- Ensure adherence to applicable GXP policies and procedures including those directed by the FDA, USP, EMA, and ICH.
- Interface with external experts to support GLP/GCP/GMP compliance and alliance activities with vendors and business partners and lead Quality Agreement creation and revision.
Education / Experience / Skills:
- BS / MS in a scientific or health-related field.
- Minimum of 12+ years of progressive compliance experience in a quality function in pharmaceutical/biotech industry, implementing and managing a QMS.
- Experience in playing a critical role in the implementation, optimization and maintenance of GxP quality systems including vendor qualification and audit programs.
- Experience with managing GMP compliance at outsourced manufacturing sites.
- Advanced understanding of the application of GMPs to early development and commercial products, FDA regulations and ICH guidelines.
- Previous experience with GMP biologics, preferably with monoclonal antibodies.
- Preference given to candidates demonstrating GCP experience as well.
- Hands-on leader, able to provide solution minded approach and flexibility to emerging challenges.
- Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationships with cross functional personnel at all levels.
Leap is an equal opportunity employer and extends equal opportunity to all individuals, without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic disposition, caregiver status, reproductive health decisions, status as a victim of domestic violence, sexual violence or stalking, credit history, criminal history, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. We are committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives.