Compliance QA Manager
Exelixis, California, MO, United States
Summary
The Compliance QA Manager, QA Core, is responsible for coordinating and maintaining inspection readiness activities and provides support for assessing proposed corrective and preventive actions in response to inspection findings. This role supports continuous improvement efforts within the Inspection Management program to enhance quality standards and operational efficiency.
Essential Duties / Responsibilities
Manage inspection logistics to support regulatory inspections, third‑party audits, and mock inspections including notification processes, logistics team coordination, inspection room preparation, and records management.
Identify and drive improvements in inspection readiness tools, templates, and training materials for inspection teams and subject matter experts.
Manage all inspection‑related documentation including notifications, document requests, presentations, storyboards, and tools within the validated inspection system and centralized document repository.
Coordinate and assess functional area inspection observation responses and associated CAPAs.
Support coordination of clinical site inspection logistics with cross‑functional groups and contract research organizations as needed.
Collect, track, and trend industry inspection observation themes and provide data as part of quality system management reviews.
Support continuous inspection readiness activities across the organization, including mock inspections, inspection logistics drills, document readiness reviews, and industry inspection readiness best practices.
Support internal and external vendor audit programs by coordinating audit preparation, post‑audit activities, and quality risk assessments.
Stay abreast of all relevant regulatory requirements related to product quality, data integrity, and supplier management.
Provide support to QA Partners.
Perform other responsibilities as required.
Supervisory Responsibilities
No supervisory responsibilities.
Education & Experience
Bachelor’s degree in biology, sciences, or related STEM disciplines and 7 years of relevant experience; or
Master’s degree in related STEM disciplines and 5 years of relevant experience; or
Combination of equivalent education and experience.
A minimum of 5–8 years of related experience in GxP quality assurance or compliance, with exposure to inspection readiness activities and support of regulatory inspections or audits.
Knowledge, Skills & Abilities
Strong written and oral communication skills.
Excellent attention to detail and organizational skills.
Applies current regulations and quality standards to deliver high quality work.
Experience supporting regulatory health authority inspections, including preparation, documentation review, coordination of activities, and post‑inspection actions.
Ability to influence decision‑makers and utilize sound problem‑solving skills to recommend options and implement effective solutions.
Highly skilled at working with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
Ability to contribute to the development of company objectives and key performance indicators.
Good organizational skills and ability to work independently.
Team player with excellent intra‑personal skills and ability to work cross‑functionally.
Strong Microsoft Office skills.
Work Environment / Physical Demands
The office is a modern, open space that fosters collaboration and creativity. Teams work closely together and share ideas. All necessary equipment, including dual monitors and ergonomic chairs, is provided to ensure a comfortable workspace.
Compensation & Benefits
The base pay range for this position is $133,000 – $189,000 annually, which may vary based on location. Total Rewards includes 401(k) with company contributions, group medical, dental, vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonuses, and stock purchase options. Employees receive 15 accrued vacation days in their first year, 17 paid holidays (including a company‑wide winter shutdown), and up to 10 sick days per calendar year.
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.
Equal Opportunity Employer Statement
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.
#J-18808-Ljbffr
The Compliance QA Manager, QA Core, is responsible for coordinating and maintaining inspection readiness activities and provides support for assessing proposed corrective and preventive actions in response to inspection findings. This role supports continuous improvement efforts within the Inspection Management program to enhance quality standards and operational efficiency.
Essential Duties / Responsibilities
Manage inspection logistics to support regulatory inspections, third‑party audits, and mock inspections including notification processes, logistics team coordination, inspection room preparation, and records management.
Identify and drive improvements in inspection readiness tools, templates, and training materials for inspection teams and subject matter experts.
Manage all inspection‑related documentation including notifications, document requests, presentations, storyboards, and tools within the validated inspection system and centralized document repository.
Coordinate and assess functional area inspection observation responses and associated CAPAs.
Support coordination of clinical site inspection logistics with cross‑functional groups and contract research organizations as needed.
Collect, track, and trend industry inspection observation themes and provide data as part of quality system management reviews.
Support continuous inspection readiness activities across the organization, including mock inspections, inspection logistics drills, document readiness reviews, and industry inspection readiness best practices.
Support internal and external vendor audit programs by coordinating audit preparation, post‑audit activities, and quality risk assessments.
Stay abreast of all relevant regulatory requirements related to product quality, data integrity, and supplier management.
Provide support to QA Partners.
Perform other responsibilities as required.
Supervisory Responsibilities
No supervisory responsibilities.
Education & Experience
Bachelor’s degree in biology, sciences, or related STEM disciplines and 7 years of relevant experience; or
Master’s degree in related STEM disciplines and 5 years of relevant experience; or
Combination of equivalent education and experience.
A minimum of 5–8 years of related experience in GxP quality assurance or compliance, with exposure to inspection readiness activities and support of regulatory inspections or audits.
Knowledge, Skills & Abilities
Strong written and oral communication skills.
Excellent attention to detail and organizational skills.
Applies current regulations and quality standards to deliver high quality work.
Experience supporting regulatory health authority inspections, including preparation, documentation review, coordination of activities, and post‑inspection actions.
Ability to influence decision‑makers and utilize sound problem‑solving skills to recommend options and implement effective solutions.
Highly skilled at working with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
Ability to contribute to the development of company objectives and key performance indicators.
Good organizational skills and ability to work independently.
Team player with excellent intra‑personal skills and ability to work cross‑functionally.
Strong Microsoft Office skills.
Work Environment / Physical Demands
The office is a modern, open space that fosters collaboration and creativity. Teams work closely together and share ideas. All necessary equipment, including dual monitors and ergonomic chairs, is provided to ensure a comfortable workspace.
Compensation & Benefits
The base pay range for this position is $133,000 – $189,000 annually, which may vary based on location. Total Rewards includes 401(k) with company contributions, group medical, dental, vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonuses, and stock purchase options. Employees receive 15 accrued vacation days in their first year, 17 paid holidays (including a company‑wide winter shutdown), and up to 10 sick days per calendar year.
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.
Equal Opportunity Employer Statement
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.
#J-18808-Ljbffr