QA Systems and Process Manager

SUMMARY/JOB PURPOSE
QA 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/RESPONSIBILITIES

• Provide independent risk-based QA oversight of GxP regulated computerized systems for IT Clinical Data Management and other functional systems as applicable
• Review 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 requested
• Develop solutions and manage project/change timelines as requested
• Create and run reports track follow-up actions and ensure data quality and compliance
• Evaluate system incidents deviations and CAPAs to maintain a validated state
• Identify and escalate compliance risks
• Review and approve CSV change controls and continuous improvement initiatives
• 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

• Bachelors 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: $145000 - $184000 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: .

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.