Jobs in the United States

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Added just now
Water Planner
State of Indiana
Indianapolis, IN
Acts as a liaison & technical advisor for steering committees, River Basin Commissions, Watershed Districts, regarding program information and technical service in water resource.
Added just now
Prin. Supplier Technical Engineer
Gardena, CA
This position reports to the Supply Chain Manager and/or the Site Sourcing Manager. The Supplier Technical Engineer is a technical resource for the Supply Chain and, at the higher levels,…
Added 1 min ago
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Program Manager, MES
AbbVie
Worcester, MA
- $109,500 to $208,500 USD / year
The Program Manager, MES will organize and lead high-performing cross-functional teams in the planning and execution of programs associated with assembly, labeling and packaging of drug…
Added 1 min ago
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Program Manager, MES
AbbVie
North Chicago, IL
- $109,500 to $208,500 USD / year
The Program Manager, MES will organize and lead high-performing cross-functional teams in the planning and execution of programs associated with assembly, labeling and packaging of drug…
Added 1 min ago
A
Program Manager, MES
AbbVie
Irvine, CA
- $109,500 to $208,500 USD / year
The Program Manager, MES will organize and lead high-performing cross-functional teams in the planning and execution of programs associated with assembly, labeling and packaging of drug…
Added 2 mins ago
Technical Project Manager (Systems Integration)
Capgemini
Atlanta, GA, GA
Capgemini is seeking an execution-driven Technical Project Manager (TPM) with strong Systems Integration (SI) delivery experience to lead complex technology engagements.
Added 2 mins ago
Senior Digital Project Manager
Consertus-US
Remote, United States
Consertus is an AI-native global capital program management and advisory firm that combines deep industry expertise with advanced digital capabilities to deliver smarter, faster, and more…
Added 2 mins ago
IT Project Manager
Northeast Grocery
Williamsville, NY · Schenectady, NY
We are looking for a Project Manager to drive large-scale programs in the Northeast Grocery Platform. This position will enable optimal IT project management and resource allocation that…
Added 3 mins ago
NW Deployment Planner II, GND - Planning, Implementation, Coordination (PIC) Team
Amazon Data Services, Inc.
Seattle, WA · Herndon, VA
Work closely with our Install/Deployment Technicians, Supply Chain & Procurement, Network Engineers and Technical Project Manager teams to ensure fast, smooth delivery of on-demand customer…
Added 3 mins ago
Hardware Test and Integration Manager, OISL
Amazon Kuiper Manufacturing Enterprises LLC
Northridge, CA
When program demands create a resourcing conflict, you make the prioritization call and own the outcome. You carry status to leadership yourself, pulled from the work rather than reported…
Added 3 mins ago
Senior Project Manager
California Mental Health Services Authority
Remote, United States
…leaders on strategy and organizational workflow alignment. The project manager is accountable for developing, implementing, and monitoring strategies and tactics that address CalMHSA goals…
Added 4 mins ago
Clinical Project Manager II
CAMRIS
Rockville, MD
We are seeking an experienced Clinical Project Manager II to support anticipated work with the National Institutes of Health (NIH), National Cancer Institute (NCI) in Rockville, MD. This…
Added 5 mins ago
Project Manager - Civil/Site
French & Parrello
Hackettstown, NJ
French & Parrello Associates (FPA) is seeking an experienced Project Manager to join our growing Civil/Site Department in Hackettstown, NJ. This is an exciting opportunity for an…
Added 5 mins ago
Project Manager - Municipal Services
French & Parrello
Hackettstown, NJ
The Project Manager – Municipal Services will oversee projects from initial planning through design and construction, with responsibility for scope, schedule, budget, technical quality, and…
Added 5 mins ago
Project Manager - Municipal Services
French & Parrello
Wall Township, NJ
The Project Manager – Municipal Services will oversee projects from initial planning through design and construction, with responsibility for scope, schedule, budget, technical quality, and…
Added 5 mins ago
Project Manager - Water & Wastewater
French & Parrello
Wall Township, NJ
The Project Manager – Water & Wastewater will oversee projects of varying size and complexity while managing technical work, financial performance, schedules, risk, and quality. In this…
Added 5 mins ago
Bridge Manager
French & Parrello
Wall Township, NJ
The successful candidate will provide leadership for FPA’s Bridge Department while serving as a Senior Project Manager on major transportation and bridge assignments throughout New Jersey…
Added 5 mins ago
Transportation Engineering Project Manager
French & Parrello
Wall Township, NJ
French & Parrello Associates (FPA) is seeking an experienced and motivated Transportation Engineering Project Manager to join our growing Transportation Group to lead projects for our…
Added 5 mins ago
Senior Transportation Engineering Project Manager
French & Parrello
Wall Township, NJ
French & Parrello Associates (FPA) is seeking an experienced and motivated Senior Transportation Engineering Project Manager to join our growing Highway & Bridge Departments at our…
Added 5 mins ago
Director, Filing Excellence Program Manager
Beam Therapeutics
Cambridge, MA
Beam is seeking an experienced Director, Filing Excellence Program Manager to provide project leadership for major global regulatory submissions, including Biologics License Applications…
Added 5 mins ago
Compliance Manager
The Nuclear Company
Columbia, SC
Provide practical training and guidance to employees, tailored to technical and project audiences
Added 6 mins ago
ENTERPRISE PROGRAM MANAGER
PSYCHOLOGICAL ASSESSMENT RESOURCES INC
Lutz, FL
The Enterprise Program Manager exists to drive complex, cross-functional initiatives toward their intended business outcomes, coordinating work across any combination of departments where…
Added 7 mins ago
Technical Project/Program Management
Applied Materials
Santa Clara, CA · Santa Clara
We are looking for an experienced Technical Program Manager / Operational Excellence Program Manager to drive 6S and other strategic initiatives across SPG Operations. This role will lead…
Added 7 mins ago
Senior Environmental Project Manager
Canacre USA, LLC
Remote, United States
The Environmental Project Manager is responsible for managing environmental projects from planning and permitting through execution and completion. This role combines project management…
Added 7 mins ago
Change Management Experienced Manager
Grant Thornton
Philadelphia, PA · San Francisco, CA · Chicago, IL · NY · Dallas, TX · Houston, TX · Boston, MA
Grant Thornton is seeking an accomplished Manager in our Workforce Transformation Change Management practice, providing our clients and engagement delivery teams with project leadership,…

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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