Associate QA CAPA Director

Company: Exelixis
Location: Alameda
Posted on: September 16, 2020

Job Description:

Position Description:

This role is responsible being the Business Process Owner for Corrective Action and Preventive Action (CAPA) Management Program at Exelixis. This includes implementing and progressively improving the CAPA process and electronic system. Responsible for driving continuous process improvements within the program and other linking programs (i.e. Deviations). Responsible for supporting the development, deployment, maintenance, and improvement of the Corrective Action and Preventive Action (CAPA) Management processes and procedures. Ensures effective deployment of CAPA requirements. Acts as primary CAPA contact, CAPA notification and consolidation point for receiving, processing, and reporting all CAPAs. Develops and updates company CAPA procedures to ensure capture and investigation of CAPAs. Maintains and analyzes problem logs to identify and report recurring issues to quality assurance management. Documents and tracks CAPA information, reported issues and problems in accordance with company guidelines and external regulatory requirements. Will collaborate with other internal groups to respond to CAPA inquiries and issues.

Position Requirements:

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for designing, implementing, performing, maintaining, and governing of the Exelixis Corrective Action and Preventive Action (CAPA) Program which includes, but not limited to:

o CAPA Procedures

o User Awareness and Competency

o CAPA Metrics and CAPA Key Performance Indicators (KPIs)

o Proactive Monitoring and Elevations to Management Review

o CAPA compliance to regulations

o Drive continuous improvement of the CAPA process as the system owner.

o Ensure the CAPA system is designed to meet standard timelines and HA regulations.

• Responsible for identifying and implementing an electronic CAPA database, act as the CAPA 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 CAPA system to ensure that all CAPAs received are appropriately investigated and concluded per the company's CAPA procedure.

o Responsible for implementing and progressively improving the CAPA process and electronic system within the Quality Management System at Exelixis as we grow our business.

o Is the primary CAPA contact for Exelixis, CAPA notification and consolidation point for receiving, processing, and reporting all CAPAs. Develops and updates company CAPA procedures to ensure capture and investigation of CAPAs.

o Provide technical CAPA/investigation process expertise to optimize CAPA creation:

? Investigate and act as first responder to any CAPA needs or development.

? Monitor, review CAPAs and determine is meets requirements.

? Ensures effective deployment of CAPA requirements.

• Responsible for supporting the development, deployment, maintenance, and improvement of the CAPA SOPs, work instructions and workflows, including:

o Direct, establish and maintain CAPA processing, including writing/revising SOPs to ensure compliance with Health Authority (HA) expectations for CAPA compliance.

• Responsible for tracking all CAPAs:

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 CAPA information, reported issues and problems in accordance with company guidelines and external regulatory requirements.

• Will collaborate with other internal groups to respond to CAPA inquiries and issues.

• Will participate in audits and inspections, representing the CAPA SOPs and records.

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.

• Has a history of completing successful cross-functional projects and driving positive compliance outcomes.

• Proven success with investigations, processing and obtaining root cause. Experience in Root Cause Analysis (RCA) methodologies.

• Proven progressive thinker who has significantly improved QMS’s, particularly the CAPA process.

• 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.

• Experience with frontline auditor and inspection interface.

• Strong people leadership skills and ability to influence others without direct authority.

• Strong interpersonal and collaboration skills – collaborates across boundaries to create process.

• Displays positive energy/ attitude and persistence to drive organization forward.

• Delivers on commitments – takes accountability for failure.

• Customer focused.

• Business minded.

• Addresses organizational or cultural barriers that could prevent success.

• Proven project management skills and success.

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.

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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Keywords: Exelixis, Alameda , Associate QA CAPA Director, Other , Alameda, California