New · posted Oct 30
Exelixis · Biotechnology
QA Systems and Process Manager
- Alameda, CA
- On-site
- Full-time
- Manager
The role
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
What you need
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.
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
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.
Travel Requirements
- 5% Up to 5% travel time
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: [email protected].
Preferrednice to have
- Experience or understanding of computer software assurance
What you'll do
SUPERVISORY RESPONSIBILITIES
- No supervisory responsibilities
Pay and benefits
$145,000 – $184,000 a year
Employer provided401k with company contributions
Medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus
Employee stock purchase and long-term incentives
Where you'll work
Alameda, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Alameda, CAWorking 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.
Equal opportunity, accessibility and legal noticesExelixis's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 30, 2026
Salary intelligence
How the pay compares
This role's midpoint is 20% above the US median for Validation & CQV roles at this level.
This roleEmployer provided
Manager roles in the US10 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $145,000 | — | $184,000 |
| All US (middle half) | $133,250 | $137,500 | $159,000 |
This role: Exelixis's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, October 30, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 131 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Exelixis's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 37 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance8
- Data and digital systems7
- Validation and qualification6
- Quality systems and risk4
- Collaboration and leadership4
- Documentation and SOPs3
- Investigations and CAPA2
- Lab testing and methods1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
Company hiring pulse
Exelixis on Regulatory Jobs
- 8
- Open roles
- 8
- Distinct roles
- 1
- Locations
By discipline
- Quality5 63%
- Regulatory3 38%
By level
- Director5 63%
- Manager2 25%
- VP & Executive1 13%
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QA Systems and Process Manager at Exelixis
Open until filled. $145K–$184K a year, employer provided.