Director, Quality Assurance

Leap Therapeutics is seeking a motivated individual with substantial biologics GMP Quality Assurance experience to be part of a growing oncology company.

The Director will work within a highly collaborative team environment to assist in developing and implementing operational plans to meet project timelines and the company’s business objectives. He/she will also work across a network of outside contractors (CRO, CDO, CMO) responsible for development, ongoing manufacture and eventual commercialization of Leap’s products.

 

General Responsibilities

The successful candidate will be responsible for the expansion, implementation, and maintenance of the eQMS system and inspectional readiness initiatives. Specific focus on GMP with opportunity to collaborate with GCP/GCP experts to expand and develop Leap’s quality system and quality department.

Director will collaborate with a cross functional team to ensure best GMP practices are implemented and followed at external contract manufacturing and testing labs and internally at Leap.

 

Specific responsibilities include:

  • Build on the existing GMP quality infrastructure to support development through Phase 3 and commercial/launch at external contract manufacturing and testing labs.

  • Assist in leading a cross functional group to establishing an industry standard GxP quality system that interfaces with all key business components.

  • Direct and manage eQMS document control systems.

  • Direct and manage Leap’s vendor qualification and audit programs.

  • 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 preparations internally and at GMP vendors.

  • Provide GMP oversight of labeling and packaging in support of clinical supply operations.

  • Ensure that the appropriate internal Standard Operations Procedures are written in accordance with regulatory requirements and global industry standards/expectations.

  • Represent GMP QA on applicable internal and external study management teams.

  • Lead training and implementation of GMP procedures and quality systems.

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

  • Interface with external experts to support GCP/GCLP/ GLP 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 10+ years of progressive compliance experience in quality functions in pharmaceutical/biotech industry with extensive GMP experience

  • Experience in playing a critical role in the optimization and maintenance of GMP quality systems including vendor qualification and audit programs

  • Experience with biologics, preferably with monoclonal antibodies

  • Experience with managing GMP compliance at outsourced manufacturing and testing sites. Preference given to candidates with GCP experience as well.

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

  • 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.

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