Exelixis, Inc.
Quality Assurance Director (Compliance) (Finance)
The Quality Assurance Director is responsible for implementing and maintaining the audit and inspection processes for GxP regulated areas including those systems managed by external vendors. This role is also responsible for ensuring compliance of internal and external audit program to applicable procedures and global regulations.
Position Requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Manages the implementation, maintenance and execution of the Exelixis Internal and Vendor Audit process.
• Prepares the risk-based audit schedule including contracting of third parties and scheduling of internal resources.
• Responsible for developing, tracking and reporting compliance and audit metrics, and communicating trends or significant findings to executive management.
• 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.
• Oversees continuous improvement of audit processes including policies, procedures, and training related to audit.
• Manages Inspection Management activities including setting the strategic plan for maintaining organizational inspection readiness across multiple projects in all stages of development or commercialization.
• Directs maintenance of inspection opening presentation materials to ensure consistency and currency;
• Manages internal logistics during GxP Inspections or Audits of Exelixis
• Oversees the provision of inspection related training and auditor training.
• Acts as Subject Matter Expertise for current global regulatory compliance expectations.
• 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.
• Responsible for staying abreast of current regulation requirements and informing stakeholders of potential impact on the organization or related systems.
• Represents QA compliance in internal presentations on quality issues, initiatives and projects with regard to audit or inspection readiness processes.
SUPERVISORY RESPONSIBILITIES:
• None
EDUCATION/EXPERIENCE/SKILLS:
Education:
• BS/BA degree in related discipline and twelve years of related experience; or,
• MS/MA degree in related discipline and ten years of related experience; or,
• PhD in related discipline and eight years of related experience, or;
• Equivalent combination of education and experience.
• May require audit certification in assigned area.
Experience:
• Typically requires a minimum ten to twelve (10-12) years of related QA, Audit or Inspection Management experience, or the equivalent combination of experience and education/training.
• At least 10+ years of progressive related experience.
• Experience in the biotech or pharmaceutical industry is required.
• Experience in presentation to Health Authorities during inspection.
• Independent Lead Auditor certification is a plus.
Knowledge/Skills/Abilities:
• Demonstrated knowledge of the GxP processes.
• Demonstrated management experience, particularly in audit or inspection management is required.
• Demonstrated ability to conduct audits of vendors and self inspection audits to assess and drive. collaborative resolution to issues.
• Working knowledge of supporting inspection preparation and inspection activities for global regulatory filings (US FDA, EMA, MHRA, PMDA, and ANVISA desired).
• Excellent verbal and written communication skills.
• 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.
• Develops technical solutions to complex problems.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Guides the successful completion of major programs, projects and/or functions.
• Interprets, executes and recommends modifications to companywide policies and/or divisional programs.
• Possesses complete understanding and wide application of technical principles, theories, concepts and techniques.
• Detailed oriented and committed to precision in execution of tasks and processes.
• Has extensive knowledge of other related disciplines.
• Must be proficient in Word, Excel, PowerPoint, and Visio.
JOB COMPLEXITY:
• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Works in partnership with Cross -functional Team including GCP, GMP and PV QA to ensure decision-making and Quality approaches related to CRS are defined.
• Able to multi-task across multiple studies and multiple stage projects.
• Works on complex issues where analysis of situations or data requires an in-depth knowledge of the clinical research and PV processes and corporate goals.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
• Work with various contractors and team members to ensure Exelixis project/program goals are met.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Exelixis is located in Alameda, CA.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.