Manager/Senior Manager, Quality Systems

 

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

 

General Responsibilities:

 

The successful candidate will be responsible for the expansion, implementation, and maintenance of the Leap GxP quality systems, management of the electronic document management system (EDMS) and performing vendor qualification and surveillance audits, and other duties as assigned.

 

This role will collaborate with a cross functional team to ensure best GxP practices are implemented, maintained, measured, and followed internally at Leap.  Initial focus on Quality Systems and document control for a virtual biopharmaceutical company

 

Specific Responsibilities Include:

 

Quality Systems:

  • Manage Leap’s quality systems, including but not limited to deviations, corrective/preventive actions, document control, approved vendor list, training, change control, material review board, etc.

  • Ensure adherence to applicable GXP policies and procedures including those directed by the FDA, MHRA, EMA, ICH, and USP.

  • Build on the existing GxP Quality Systems infrastructure to support through Phase 3 and commercial/launch.

  • Assist with Inspection Readiness activities.

  • Interface with internal experts to support GLP/GCP/GMP compliance and alliance activities.

  • Design a metrics program.

 

Document Control:

  • Oversee the document life-cycle management using ZenQMS EDMS.

  • Manage the EDMS and perform the role of System Administrator.

  • Assist Leap team with EDMS workflows.

  • Ensure that the appropriate internal Standard Operating Procedures are written in accordance with regulatory requirements and global industry.

 

Vendor Auditing:

  • Conduct internal audits of GXP processes.

  • Write audit reports, audit observations, and follow-up with auditee vendors on findings.

  • Conduct vendor qualification and surveillance audits, as Lead Auditor or assistant Auditor.

 

Education / Experience / Skills:

 

  • BA/BS in a scientific or health-related field.

  • Minimum of 7+ years of progressive compliance experience in quality functions in biopharmaceutical/pharmaceutical industry with Quality Systems experience.

  • Preference given to candidates demonstrating ZenQMS EDMS experience.

  • ASQ/SQA Auditor Certification a plus.

  • Experience of managing internal pharmaceutical Quality Systems.

  • Advanced understanding of the application of cGMPs to early development and commercial products, FDA regulations and ICH guidelines.

  • Experience with GLP and GCP a plus.

  • Hands-on self-starter, 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.