Generate metrics to support business goals
Manage updates to business guidances and user reference documentation
Continuously improve monitoring, user issues and deliver better value to the customer
Support activities for internal and external audits/inspections
Provide technical expertise to enable the transformation from Computer System Validation (CVS) to Computer software Assurance (CSA)
Drive issues to resolution
Performs other duties as assigned
Complies with all policies and standards
SUPERVISORY RESPONSIBILITIES
No supervisory responsibilities
EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES
Education
Bachelor's degree in science or related field and 7 years of related experience; or,
Equivalent combination of education and experience.
Experience
5+ years of experience working on GxP validated applications in a pharmaceutical or regulated environment.
Experience and knowledge of the quality and regulatory business processes.
Direct hands-on experience implementing GxP computerized systems and maintaining validated state.
Knowledge, Skills and Abilities
Required
Strong process improvement skills and orientation
Proven business and technology skills, with proven success in providing customer-oriented technology solutions environment
Excellent proven communication (verbal and written) and presentation skills, interacting with user and technical communities
Ability to communicate ideas in both technical and user-friendly language
Strong team player with collaborative approach to work
Deep understanding of applicable regulatory guidelines (21 CFR Part 11, EU Annex 11, ICH GCP/GLP, data integrity principles, etc.)
General knowledge of database and computer networking
Working knowledge/experience with SaaS systems
Ability to work with confidential data
Prioritizes and drives for results
Preferred
Experience or understanding of computer software assurance
Travel Requirements
5% Up to 5% travel time
#LI-HG1
Location: Alameda, CA

Range for this position: $145,000 - $184,000

The base pay offered will take into account 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 recruiting process, please email us at: ApplicantAccommodations@exelixis.com.
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.
