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Added 1 min ago
Project Manager - Burton Area
The Pivot Group Network
Burton · Burton, MI
New Product Introduction Manager, Capital Projects Manager, Production Project Lead, Plant Project Coordinator, Manufacturing Project Manager, Project Engineer, Program Manager, Operations…
Added 1 min ago
Electrical Substation Project Engineer - 2
GE Vernova
Oakbrook Terrace, IL
Resolve technical issues in coordination with the customer and project manager.
Added 1 min ago
Development
University of Utah
Salt Lake City, UT
The Development Engagement Manager will build on and develop the UMFA’s annual fund program and mid-range individual donors to create and implement a comprehensive, multi-level funding…
Added 2 mins ago
Risk and Safety Business Partner III
City of Greeley
Greeley, CO
The City of Greeley is committed to providing a comprehensive total rewards program that supports employees in their work by encouraging excellence and investing in employee development and…
Added 3 mins ago
Senior Manager, Proprietary Programs Integrated Planning and Scheduling
The Boeing Company
Seal Beach, CA
This manager will lead integrated planning and scheduling professionals supporting program execution across development, production, and operations portfolios. Responsibilities include…
Added 3 mins ago
Finance Manager
Abbott
Sylmar, CA
We are currently recruiting for an experienced, high performing Finance Manager – R&D to support Abbott’s Cardiac Rhythm Management (CRM) division in our Sylmar, CA location. The Finance…
Added 3 mins ago
Business Analytics Consultant Senior - Regulatory Reporting
PNC Bank NA
PA · Birmingham, AL · Cleveland, OH
Work cross-functionally with Finance, Risk, Technology, Data Management, and Regulatory Reporting teams to support project execution and issue resolution.
Added 3 mins ago
Operations Manager I, Eye Care Services Clinical Ops and Optical Services - Baldwin Park
Kaiser Permanente
Baldwin Park, CA
…what is expected during and after an emergency; and leading project teams, initiatives and monitoring implementation and performance on daily operations and new initiatives to meet business…
Added 3 mins ago
Warehouse Assistant Operations Manager
U.S. Venture, Inc.
IN
Ability to project a positive image to customers
Added 3 mins ago
Mgr Electronics Engineering 1 - Ground Systems Intern Development Manager
Northrop Grumman
Manhattan Beach, CA
Experience collaborating with other Engineering and Production disciplines across the Sector, as well as Talent Acquisition, Human Resources, or Project/Program Management
Added 3 mins ago
Product Manager (DRM - Platform & DevSecOps Pipeline)
Northrop Grumman
Redondo Beach, CA
The Product Manager (DRM) – Manager Systems Engineering 3 is the senior technical and program manager for the large‑scale DRM (Deployment Release Manager) software system effort comprised…
Added 3 mins ago
Senior Behavioral Health Manager
Volunteers of America Los Angeles
Downey, CA
The Senior Behavioral Health Manager is generally responsible for identifying and marshalling the resources necessary to achieve the organization's goals through the various programs…
Added 3 mins ago
PRINTING COORDINATOR NF3*
U.S. Marine Corps
Marine Corps Air Station Miramar, CA
Added 3 mins ago
ADMINISTRATIVE/TECHNICAL SPECIALIST
Naval Sea Systems Command
Port Hueneme, CA
Added 4 mins ago
EQOL Project Manager 1 - 30839
Huntington Ingalls Industries
National City, CA
…continue to maintain the Navy’s readiness! We are seeking a Project Manager to lead our SEMAT EQOL team located in San Diego, CA. This Project Manager will be responsible for leading the…
Added 4 mins ago
Information Technology Systems Integration Associate
SAIC
El Segundo, CA
…of IT capabilities in support of the day-to-day integrated program management portfolio of space-related research, development, production, and lifecycle acquisition activities. This effort…
Added 4 mins ago
Information Technology Systems Integration Associate
SAIC
El Segundo, CA
…of IT capabilities in support of the day-to-day integrated program management portfolio of space-related research, development, production, and lifecycle acquisition activities. This effort…
Added 4 mins ago
Senior Marketing Product Manager, Laboratory Diagnostics
Antech Diagnostics
Fountain Valley, CA
Antech is seeking a highly driven and experienced Sr. Marketing Product Manager to focus on executing the short- and long-term vision for Laboratory Diagnostics. This role requires a blend…
Added 4 mins ago
Employee Experience Project Manager/Principal Project Manager
Northrop Grumman
Manhattan Beach, CA
Northrop Grumman Defense Systems is seeking a Project Manager/Principal Project Manager to join our Strategic Deterrent Systems (SDS) Division in Manhattan Beach, CA as a key member of the…
Added 4 mins ago
Agronomy Specialist
Corteva Agriscience
Woodland, CA
The Agronomy Specialist will work under the direction of the Agronomy Lead and Station Manager to provide agronomic support to all groups within the Woodland, CA Research Station. The…
Added 4 mins ago
Field Marketing Manager
EPAM Systems
Santa Clarita, CA
Join our North American marketing team in a high-impact role covering the Southwest USA region. As a Field Marketing Manager at EPAM, you serve as the primary field marketing partner for…
Added 4 mins ago
AD
Marketing Product Manager, Laboratory Diagnostics
Antech Diagnostics
Fountain Valley, CA
- $99,330 to $124,000 USD / year
Antech is seeking a highly driven Marketing Product Manager to focus on executing the short- and long-term vision for Laboratory Diagnostics. This role requires a blend of strategic…
Added 4 mins ago
Sales Rep, Peripheral Nervous System (PNS) – Palm Springs/Inland Empire, CA
Medtronic
Palm Springs, CA
Contribute and assist with project team activities as assigned, including team participation.
Added 4 mins ago
Sr Program Manager
Aerospace
Clearwater, FL
As a Program Manager, Aerospace Defense and Space here at Honeywell, you will lead and manage defense munition programs within the aerospace sector, ensuring successful project execution…
Added 4 mins ago
Strategic Account Manager
MasTec Advanced Technologies
CHICAGO PARK, CA
The Strategic Account Manager advances Mission Critical Power Delivery growth by developing strategic customer relationships, identifying and shaping opportunities, and coordinating…

Exelixis Inc

QA Systems and Process Manager

Alameda, CA, United States

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Job details

Posting language: English
Posted: Oct 29, 2026

Original job description

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

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

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.

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