SUMMARY/JOB PURPOSE (Basic purpose of the job):

• The Compliance QA Director leads the company’s GxP inspection readiness ensuring ongoing preparedness for global health authority inspections. This role manages regulatory inspections and responses, directs internal audits and mock inspections, and provides oversight of corrective and preventive actions to drive timely closure and risk reduction. Serving as a compliance subject matter expert, partners cross-functionally to provide guidance on GxP processes and continuously improves inspection readiness practices across the organization.

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Leads the management of health authority agency inspections and coordination of responses to any health authority agency observations.
• Responsible for setting the strategic plan for maintaining organizational inspection readiness across the organization and developing an annual inspection readiness plan, ensures activities are completed, and drives continuous improvement initiatives.
• Leads projects which have strategic impact on the organization and act as a role model for change by demonstrating commitment to the success of the project.
• Acts as the Subject Matter Expert for current global regulatory compliance expectations and proactively reviews changes in regulatory requirements and industry environment that would necessitate future changes and drives completion of impact assessments.
• Partners with other groups including Regulatory Affairs, Clinical Operations, Drug Safety, Pharmaceutical Operations and Supply Chain, and Non-clinical Development, regarding compliance assessments and provide compliance guidance related to GxP processes.
• Leads cross-functional teams in managing inspection readiness activities.
• Assesses proposed corrective or preventive actions in response to audit or inspection findings, track and report closure of items, and provide management visibility to areas of risk or concern.
• Manages implementation, maintenance, execution of internal audits and mock inspections.
• Represents Compliance QA in internal presentations on quality issues, initiatives and projects regarding audit or inspection readiness processes.
• Identifies new contract auditors, oversees the establishment of agreements and ensures all commitments are met by contract auditors and monitors auditor assignments and budget.
• Ensures that inspection and audit tools are appropriate and fit for purposes.
• As necessary, execute external vendor audits as part of the Supplier Quality Management program.
• Other responsibilities as required.

SUPERVISORY RESPONSIBILITIES:

• No supervisory responsibilities.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• Bachelor’s degree in biology, sciences, or related STEM disciplines and 13 years of relevant experience; or
• Master’s degree in related STEM disciplines and 11 years of relevant experience; or
• Equivalent combination of education and experience.

Experience:

• Must have audit and inspection management work experience within pharmaceutical quality compliance or quality assurance.
• A minimum of 11 years of related experience in GxP quality compliance or quality assurance, with leadership roles in inspection readiness and audits. Recognized as a knowledgeable resource within the department and from other departments on a range of topics and someone whose opinion is sought as a regulatory resource.

Knowledge, Skills and Abilities:

• Independent contributor with minimal supervision.
• Excellent written and oral communication skills.
• Excellent attention to detail and organizational skills.
• Demonstrated knowledge of regulatory requirements and applied current regulations and quality standards to deliver high quality work.
• Demonstrated management experience, particularly in audit or inspection management, is required.
• Working knowledge of supporting inspection preparation and inspection activities for global regulatory filings (US FDA, EMA, MHRA, PMDA, and ANVISA desired).
• Experience in supporting regulatory health authority inspections, including preparation, documentation review, coordination of activities, and post-inspection actions.
• Ability to influence others as part of a collaborative team and negotiate effective solutions, strong interpersonal and social skills.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways
• Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
• Develops technical solutions to complex problems.
• Possesses complete understanding and wide application of technical principles, theories, concepts and techniques.
• Able to multi-task across multiple studies and multiple stage projects.
• Exercises independent judgment in methods, techniques and evaluation criteria for projects, programs and people and guides the successful completion of those programs and projects.
• Works in partnership with cross-functional teams.
• Work with various contractors and team members to ensure Exelixis project/program goals are met.
• Strong user of Microsoft Office applications.

Work Environment/Physical Demands:

Our office is a modern, open space that fosters collaboration and creativity.  Teams work closely together, sharing ideas and solutions in a supportive atmosphere.  We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

• Travel requirements: 20%.

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