Senior Director, Quality Assurance
Company: Leap Therapeutics
Posted on: August 7, 2022
Company Summary: Leap Therapeutics (Nasdaq: LPTX) is focused on
developing targeted and immuno-oncology therapeutics. Leap's most
advanced clinical candidate, DKN-01, is a humanized monoclonal
antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in
clinical trials in patients with esophagogastric, hepatobiliary,
gynecologic, and prostate cancers. Leap has entered into a
strategic partnership with BeiGene, Ltd. for the rights to develop
DKN-01 in Asia (excluding Japan), Australia, and New Zealand. Leap
has a strong financial position and in September 2021 closed a
public offering with gross proceeds to Leap of approximately $104
million. Leap is based in Cambridge, MA. For more information about
Leap Therapeutics, visit http://www.leaptx.com.
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) and Good Laboratory Practice (GLP). Senior Director will
collaborate with a cross functional team provide oversight to
external vendors to ensure best GxP practices are implemented and
followed at internally Leap at contract service providers including
manufacturing organizations, testing laboratories, clinical
- Lead the continued development of the GxP quality
infrastructure to support Leap through Phase 3 and
commercial/launch at external contract manufacturing and testing
- Direct and manage internal eQMS document control systems.
- Direct and manage Leap's vendor qualification and audit
- Manage and mentor the 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,
chance 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 study
- Lead training and implementation of GXP procedures and quality
- 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.
- 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.
- Previous experience with GMP biologics, preferably with
- Preference given to candidates demonstrating GCP experience as
- Experience with managing GMP compliance at outsourced
- Advanced understanding of the application of GMPs to early
development and commercial products, FDA regulations and ICH
- 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
- Limited travel may be required.
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.
Keywords: Leap Therapeutics, Cambridge , Senior Director, Quality Assurance, Executive , Cambridge, Massachusetts
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