Compliance QA Manager

SUMMARY/JOB PURPOSE:
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 at Exelixis, including notification process, logistics team, inspection room preparation, and records management.

• Identify and drive improvements in the inspection readiness tools, templates and training material for inspection team and subject matter experts.

• Manage all inspection related documentation including inspection notifications, document requests, presentations and storyboards, and tools within the validated inspection system and centralized document repository.

• Coordinate and provide assessment of functional area inspection observation responses and associated CAPAs.

• Support the coordination of clinical site inspection logistics with the different cross functional groups and contract research organization, as needed.

• Collects, tracks, and trends industry inspection observation themes and provides 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.

• Supports 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.

• 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 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. 

Experience:
A minimum of 5-8 years of related experience in GxP quality assurance or quality compliance, with exposure to inspection readiness activities and support of regulatory inspections or audits.

Knowledge, Skills and 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 in 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 in the ability to work 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 intrapersonal skills and ability to work cross functionally.

• 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.

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $133,000 - $189,000 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

If you have a disability and need an accommodation in relation to the application and/or recruitment process, please email us at: [email protected].

WORKING CONDITIONS:

Our office is a modern 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.

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.