Associate Director, Quality Assurance

Leap Therapeutics is seeking motivated individuals with clinical quality assurance experience to be part of a growing oncology company. Successful candidates will work within a highly collaborative team environment to assist in developing and implementing operational plans designed to meet project timelines and the company’s business objectives.

The successful candidate will independently collaborate with various functions including (but not limited to) clinical operations, data management, translational medicine, pharmacovigilance and medical to ensure best practices are implemented and followed.


Responsibilities
The Associate Director will be responsible for the development, implementation and maintenance of Quality Assurance systems and inspectional readiness initiatives. This individual will be responsible for the management of internal and external audit program, risk-based audit plan development and the conduct of GLP/CGP/GVP audits. Plan and prepare site and vendor audits.


Specific responsibilities include:

  • Develop and oversee internal processes and systems related to GCP activities

  • Ensure that audit results are formally and consistently recorded, conducted, reported and that appropriate corrective/preventive actions have been requested and documented effectively

  • Participate in the risk assessment of all new and current vendors/CRO partners and conduct or coordinate vendor qualification audits/assessments as needed

  • Direct and manage the GCP audit program, prepare audit schedule and establish the audit strategy for investigational drug clinical research programs

  • Ensure timely completion of audit plans, reports and responses according to company procedures

  • Manage post-audit follow-up on any necessary corrective and preventive actions.

  • Coordinate and manage Audit Consultants as appropriate

  • Manage the Leap Vendor Qualification and reassessment program

  • Identify compliance issues and determine approach to complex compliance issues and report findings to management with recommendations for resolution and verify appropriate CAPAs have been implemented and documented.

  • Lead GCP inspection readiness within Leap and manage inspection activities.

  • Represent Clinical QA on applicable study management teams, advise on GCP compliance matters

  • Partner with other functional groups including Regulatory Affairs, Clinical Operations, Translational Research, regarding compliance issues and provide compliance guidance to all audited parties.

  • In collaboration with other functional groups, ensure that appropriate Standard Operations Procedures are written in accordance with regulatory requirements and global industry standards

  • Lead training and implementation of GCP procedures and quality systems, as required

  • Collaborate with regulatory on inspection readiness and preparedness activities (i.e., sponsor monitor, sites, etc.) and provide guidance and support for all GxP inspection activities

  • Develop and manage periodic reports of key Clinical Quality metrics to management, as requested

  • Create and support continuing education and quality/compliance awareness within the organization

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Education / Experience / Skills:

  • Minimum Bachelor of Science degree, Master’s degree preferred

  • Minimum of 7 years of progressive compliance experience in quality functions in pharmaceutical/biotech industry with extensive GCP and broad GLP experience

  • Previous experience preparing for and leading Health authority inspections

  • Hands-on leader, able to provide solution minded approach and flexibility to emerging challenges

  • Extensive knowledge of technical concepts requiem for all aspects of GCP Auditing

  • Thorough knowledge and application of international requirements of Good Clinical Practice (GCP) and ICH Guidelines

  • Strong global knowledge (desirable) and understanding of regulations applicable to the conduct of clinical trials

  • Direct experience in development and oversight of Quality Management Systems.

  • Extensive experience supporting regulatory authority inspections of clinical research activities

  • Experience in providing training on key quality and regulatory compliance information

  • Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationships with cross functional personnel at all levels.

  • Up to 25% travel may be required (travel may be domestic and international)

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