Associate QA Audit Director at Exelixis, Inc. in Alameda, California
Posted in General Business 30+ days ago.
Type: Full-Time
Job Description:
Position Description:
This role is the Business Process Owner for the Audit Management Program at Exelixis. 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. Also includes for driving continuous process improvements within the program and other linking programs (i.e., CAPA). Responsible for supporting the development, deployment, maintenance, and improvement of the Audit Management processes and procedures. Ensures effective deployment of audit requirements. Acts as primary audit contact, audit notification and consolidation point for receiving, processing, and reporting all audits. Develops and updates company audit. Maintains and analyzes problem logs to identify and report recurring issues to quality assurance management. Documents and tracks Audit information and timelines, reports issues and problems in accordance with company guidelines and external regulatory requirements. Will collaborate with other internal groups to respond to audit inquiries and issues.
Position Requirements:
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Responsible for designing, implementing, performing, maintaining, and governing of the Exelixis Audit Management Program which includes, but not limited to:
o Audit Procedures
o User Awareness and Competency
o Audit Metrics and Audit Key Performance Indicators (KPIs)
o Proactive Monitoring and Elevations to Management Review
o Audit compliance to regulations
o Drive continuous improvement of the audit process as the system owner.
o Ensure the Audit system is designed to meet standard timelines and HA regulations.
• Responsible for identifying and implementing an electronic Audit database, act as the audit system Administrator which includes module implementation, effective roll-lout/launch company-wide, training for system users, password processing, and module expert; along with:
o Establish, monitor and maintain audit system to ensure that all audits received are appropriately investigated and concluded per the company's audit procedure.
o Responsible for implementing and progressively improving the audit process and electronic system within the Quality Management System at Exelixis as we grow our business.
o Acts as the primary audit contact for Exelixis, audit notification and consolidation point for receiving, processing, and reporting all audits findings. Develops and updates company audit procedures to ensure capture audit findings.
o Provide technical audit expertise to optimize audit creation:
• Responsible for supporting the development, deployment, maintenance, and improvement of the audit SOPs, work instructions and workflows, including:
o Direct, establish and maintain audit processing, including writing/revising SOPs to ensure compliance with Health Authority (HA) expectations for audit compliance.
• Responsible for tracking all audits:
o Analyzes problem logs to identify and report recurring issues to quality assurance management while ensuring records are accurate and in compliance.
o Documents and tracks Audit information, reported issues and problems in accordance with company guidelines and external regulatory requirements.
• Will collaborate with other internal groups to respond to audit inquiries and issues.
• Will participate in audits and inspections, representing the audit SOPs and records.
• Addresses organizational or cultural barriers that could prevent success.
SUPERVISORY RESPONSIBILITIES:
• None.
• Indirectly lead teams assigned to address a project.
EDUCATION/EXPERIENCE/SKILLS:
• Bachelor's degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
• At least 10 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
EXPERIENCE:
• Minimum of 6 years of FDA experience, including participation in inspections and audit program maintenance.
• Has a history of completing successful cross-functional projects and driving positive compliance outcomes.
• Demonstrated management experience, particularly in audit or inspection management is required.
• Experience with frontline auditor and inspection interface.
KNOWLEDGE, SKILLS, AND ABILITIES:
• 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).
• Strong working knowledge of FDA Quality System Regulations and Pharmaceutical guidelines, 21 CFR Part 211. ISO understanding is a bonus. Deep understanding of the biotech/pharma manufacturing and quality processes, including US and EU regulations, ICH guidelines and other industry standards.
• Strong people leadership skills and ability to influence others without direct authority.
• Strong interpersonal and collaboration skills - collaborates across boundaries to create process.
• Demonstrated knowledge of the GxP processes.
• Displays positive energy/ attitude and persistence to drive organization forward.
• Delivers on commitments - takes accountability for failure.
• Customer focused.
• Business minded.
• Detailed oriented and committed to precision in execution of tasks and processes.
• Must be proficient in Word, Excel, PowerPoint, and Visio.
JOB COMPLEXITY:
• Excellent verbal and written communication skills.
• Superior communication skills. Able to provide oral, written, and formal presentations to senior management, middle management and line staff.
• Demonstrated ability to partner with other functional groups to achieve business objectives.
• Ability to effectively lead cross-functional project teams.
• Escalates and drives resolution of project issues.
• Strong attention to detail and creative problem-solving skills
• Ability to interpret and analyze statistical data, understand and resolve technical challenges, interface with internal technical experts, and manage multiple priorities.
• Works in partnership with cross-functional Team including GLP, GXP, GVP, GCP, GMP and to ensure decision-making and Quality approaches are defined.
• 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.
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