Associate Director/Director, GMP Quality Assurance

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

They 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.


General Responsibilities
The successful candidate be responsible for the expansion, implementation, and maintenance of the GMP Quality Assurance system and inspectional readiness initiatives.

They will collaborate with various functions including manufacturing, quality control, and supply chain 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

  • Direct and manage the GMP vendor qualification and audit programs

  • Participate in batch release including the review of batch records 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

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

  • Direct and manage GMP document control systems

  • 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

 

 

Education / Experience / Skills:

  • BS/ MS in a scientific or health-related field

  • Minimum of 7+ 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

  • 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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