Director, Quality Assurance

About Ikena
Ikena Oncology (NASDAQ: IKNA) is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing five programs that include four product candidates in either clinical development or IND-enabling studies and has a global strategic collaboration with Bristol Myers Squibb.

Role Description
Ikena is searching for versatile Director, Quality Assurance who will be responsible for developing and maintaining phase appropriate quality systems related to oversight of all of Ikena’s GxP related activities. Reporting the Head of Technical Operations, the Director, Quality Assurance will be responsible for ensuring Ikena’s compliance across cGMP, GCP and GLP activities. This will include the manufacture of cGMP drug supply, execution of clinical operations (GCP), and controls related to external GLP study sites. The Director, Quality Assurance will provide both guidance and actively development and management of quality systems procedures for Ikena’s early-stage pipeline, while implementing procedures and systems that would scale to support the organizational needs. Oversight will include maintenance and maturation of Ikena’s quality management systems for internal procedures and training, as well as the coordination of external audits and vendor qualification involved in all of Ikena’s regulated industry activities. This role will work closely with Technical Operations,Chief Medical Officer and Clinical Development Operations and Ikena’s network of existing quality consultants to ensure internal and external compliance and uphold a high level of quality standards.

Responsibilities

  • Manage the internal QMS, including identification and implementation of necessary systems/platforms to enable and support organization growth
  • Ensures Phase appropriate compliance with quality systems, quality procedures, and quality policies
  • Provide GMP oversight of drug substances/products produced at contract manufacturing sites, including document review and final product release
  • Provide guidance on GCP activities and support development and implementation of a comprehensive quality framework including implementation of quality plans and related clinical processes/procedures
  • Support external GLP activities through protocol and report review
  • Manage vendor qualification , selection process and vendors oversight , including oversight of all external audits
  • Represents company as host of regulatory inspections at applicable contract sites involved in all GxP activities
  • Establish ,oversees and/or execute job specific training programs for all Ikena employees
  • Directs all GXP compliance audits as required
  • Reviews, approves, and directs implementation of changes to controlled documents and processes (e.g., SOPs, Specifications, Methods, etc.), both internally and externally, as needed


Qualifications

  • A minimum of 12 years’ experience in pharmaceutical industry, including at least 8 year in a quality function in an FDA-regulated environment
  • Degree in chemistry, biochemistry, biology, microbiology or similar is preferred
  • Comprehensive knowledge of quality principles and FDA/EU GMP regulations, in understanding of all GxPs
  • Strong technical writing and interpersonal skills; with the ability to interact effectively with all levels within the organization, external third parties, and regulatory authorities
  • Experience with quality systems focused on oversign of external operations/activities a must
  • Experience in both big pharma and small biotechnology companies environment is highly desirable
  • Experience with implementation and management of electronic systems
  • Effectively developed and executed organization wide training programs
  • Able to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
  • Self-driven, independently motivated, detail-oriented, organized and excellent problem-solving skills
  • Effective decision maker that has demonstrated ability to assess, manage and navigate quality and compliance risks
  • Must be able to travel, domestically and internationally, as required, and when safe to do so, to support our external relationships and operations

Personal attributes: team oriented, goal-driven, organized, highly collaborative, open-minded, data-driven, creative, persistent in the face of obstacles and uncertainty, flexible, self-aware of strengths and weaknesses, objective in the evaluation of data and strongly optimistic about overcoming challenges.

Application Form

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