ESSENTIAL JOB FUNCTIONS:

• Leads the Quality Unit responsible for Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Manufacturing Practices (cGMP), Good Pharmacovigilance Practices (GVP), and Computer Software Validation (CSV).
• Develops, implements, and manages the Quality System to the standards expected by Health Authorities to support clinical development, commercial operations, and the post-approval product lifecycle.
• Commercial product disposition and end-to-end quality oversight of manufacturing, testing, packaging, labeling, storage, and distribution activities.
• Governance and quality oversight of the commercial supplier network, including CMOs, contract laboratories, packagers, distributors, 3PLs, and applicable specialty-pharmacy partners.
• Oversight of the commercial product quality lifecycle, including product complaints, investigations, returns, field alert reports, recalls, market actions, and counterfeit or product-integrity concerns.
• Provides Quality oversight for internal GCP, GMP, GLP, and GVP activities.
• Ensures appropriate Quality oversight of CMOs, laboratories, suppliers, packagers, distributors, 3PLs, and alliance partners
• Leads Inspection Readiness and/or Inspection Preparedness efforts.
• Acts as lead/Host contact for GxP site inspections.
• Manages Quality System Reviews and presents to Management.
• Evaluates GxP activities for continuous improvement opportunities to the Quality System.
• Ensures risk-based quality management (RBQM) is applied as appropriate to clinical studies.
• Manages critical GxP product-quality, data-integrity, safety, and compliance events
• Identifies potential Quality risks to strategic and/or operational plans and proposes options to mitigate risks.
• Manages GxP Quality personnel, activities, and budget.

JOB SPECIFICATIONS:

• Bachelor’s degree in a Life Sciences discipline or equivalent.
• A minimum of 18 years of relevant experience in a regulated biotech, or pharmaceutical industry in a Quality Assurance function.
• Clinical development, commercial launch, and marketed-product lifecycle experience with strong experience supporting NDA approvals, MAAs, commercial launches, and post-approval submissions
• Experience with developing, implementing, and maintaining GxP Quality System which ensures compliance to GxP and regulatory standards.
• Experience in managing, hosting and/or supporting Health Authority inspections.
• Demonstrates proven track record of leadership, communication, and motivation skills with internal and external Vendors.
• A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs.
• Provide solutions to issues. Solutions are imaginative, thorough, practical, and consistent with objectives.
• Solves conflict and addresses workplace issues in professional and collaborative manner.
• Flexibility and ability to provide a solution-based approach to emerging challenges and changing priorities.
• Clear, concise writing skills and good verbal presentation skills.
• Self-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities.
• Ability to interact constructively and efficiently with co-workers within and across departments, Management, and Vendors.
• Owns and makes final decisions for the function, including those with significant impact on portfolio strategy, organizational priorities, and business outcomes.
• Leads cross-functional alignment at the executive level, partnering with senior leaders to drive integrated strategy and ensure execution against enterprise priorities.
• Communicate decisions and recommendations with clear justification.
• Ability to resolve day-to-day issues efficiently while maintaining compliance.
• Independently determines and develops approach to solutions.
• Proficient in Veeva QualityDocs.
• Proficient in Word, Excel, PowerPoint, SharePoint.
• Ability to travel for both domestic and international business.

The base range for a Vice President is $325,000 - $372,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

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