QA Systems and Process Manager

SUMMARY/JOB PURPOSEQA Process and Systems Manager is responsible for quality assurance oversight of risk-based validation and lifecycle compliance of GxP computerized systems. This role oversees end-to-end lifecycle validation state of computerized systems, from initial assessment and implementation through operation, periodic review, changes, and system retirement. The QA Process and Systems Manager partners cross-functionally with IT, system owners, business owners, operational teams and external vendors and service providers to ensure data integrity, audit and inspection readiness, continuous improvement, and compliance.ESSENTIAL DUTIES/RESPONSIBILITIESProvide independent, risk-based QA oversight of GxP regulated computerized systems for IT, Clinical Data Management and other functional systems, as applicableReview and approve validation deliverables (risk assessments, validation plans and tests, user acceptance tests, test evidence, summary reports, change controls, deviations)Author and execute of CSV implementation plans in a timely, as requestedDevelop solutions and manage project/change timelines, as requestedCreate and run reports, track follow-up actions and ensure data quality and complianceEvaluate system incidents, deviations and CAPAs to maintain a validated stateIdentify and escalate compliance risksReview and approve CSV change controls, and continuous improvement initiativesGenerate metrics to support business goalsManage updates to business guidances and user reference documentationContinuously improve monitoring, user issues and deliver better value to the customerSupport activities for internal and external audits/inspectionsProvide technical expertise to enable the transformation from Computer System Validation (CVS) to Computer software Assurance (CSA)Drive issues to resolutionPerforms other duties as assignedComplies with all policies and standardsSUPERVISORY RESPONSIBILITIESNo supervisory responsibilitiesEDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIESEducationBachelor's degree in science or related field and 7 years of related experience; or,Equivalent combination of education and experience.Experience5+ 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 AbilitiesRequired:Strong process improvement skills and orientationProven business and technology skills, with proven success in providing customer-oriented technology solutions environmentExcellent proven communication (verbal and written) and presentation skills, interacting with user and technical communitiesAbility to communicate ideas in both technical and user-friendly languageStrong team player with collaborative approach to workDeep 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 networkingWorking knowledge/experience with SaaS systemsAbility to work with confidential dataPrioritizes and drives for resultsPreferred:Experience or understanding of computer software assuranceTravel Requirements5% Up to 5% travel time#LI-HG1Location: 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: View email address on click.appcast.io 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.SummaryLocation: Alameda, CAType: Full time