QA Systems and Process Manager

Exelixis; Alameda (CA); Sur place; USD 145 000 - 184 000; Plein temps

Avantages offerts par ce poste

401k plan with generous company match

group medical insurance

dental and vision coverage

life and disability insurance

flexible spending accounts

annual bonus program

Résumé du poste

Exelixis in Alameda, CA is seeking a QA Process and Systems Manager to provide risk-based QA oversight of GxP validated applications, managing end-to-end lifecycle from validation through operation and retirement, and ensuring data integrity and inspection readiness.

You will partner with IT, data owners, and external vendors, review deliverables, drive continuous improvement, support audits, and lead CSV to CSA transformations, with about 5% travel.

Qualifications

• Bachelor's degree in science or related field and 7 years of related experience; or, Equivalent combination of education and 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.

Responsabilités

• 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.

Connaissances

Process improvement

Business & tech skills

Communication skills

Idea communication

Team player

Regulatory guidelines

Database basics

Networking basics

SaaS familiarity

Confidential data handling

Results orientation

Formation

Bachelor's degree in science or related field

Equivalent combination of education and experience

Description du poste

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 escape 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

• 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, CARange 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.

• 401k plan with generous company contributions
• group medical
• dental and vision coverage
• life and disability insurance
• 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
• up to 10 sick days throughout the calendar year

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.