Jobs in the United States

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Added 12 mins ago
Construction Engineer VII
Fluor
Hawesville, KY
Support the construction efforts by providing technical support to craft and supervision as well as helping to satisfy Quality requirements on the project. Initiates action when necessary…
Added 12 mins ago
Construction Engineer VII
Fluor
Hawesville, KY
Support the construction efforts by providing technical support to craft and supervision as well as helping to satisfy Quality requirements on the project. Initiates action when necessary…
Added 12 mins ago
Business Intelligence and Analytics Manager, Reporting and Data Analytics
Machinify
La Grange, KY
The Healthcare Business Intelligence and Analytics (BIA) Manager owns client reporting, compliance reporting, and performance analytics spanning various programs. This position will…
Added 12 mins ago
Technical Area Manager, re:Cycle Reverse Logistics
Amazon
Florence, KY
re:Cycle Reverse Logistics is looking for a Technical Area Manager for its Reverse Logistics operation based in Florence, KY. Our mission is to manage and scale information technology asset…
Added 12 mins ago
Supervisory Clinical Laboratory Scientist
Veterans Affairs, Veterans Health Administration
Lexington, KY
Added 12 mins ago
Senior Technical Product Manager - ServiceNow HRSD & Employee Center Pro
CVS Health
Frankfort, KY
…ideal candidate will possess a combination of functional and technical expertise, as well as a demonstrated ability to work collaboratively with both technical and non-technical partners.…
Added 12 mins ago
Training Content & Creative Development Specialist- Healthcare
RELX INC
Frankfort, KY
Working closely with the Healthcare Program Manager, you will translate approved learning strategies, curriculum requirements, and business objectives into clear, engaging,…
Added 12 mins ago
C
Project Manager - Fleet
CBRE
Frankfort, KY
- $90,000 to $110,000 USD / year
As a CBRE Project Manager on theIntegrated Fleet Services (IFS) team, you'll run fleet telematics and vehicletechnology programs across North America, from technician mobilization…
Added 12 mins ago
Director, Technical Program Management (Remote-Eligible)
Capital One
Frankfort, KY
Do you love driving complex technical initiatives and pioneering in the technology space? Do you enjoy solving complex business problems in a fast-paced, collaborative, inclusive, and…
Added 12 mins ago
Cyber Operate Manager - IAM PBAC Architect/Engineer
Deloitte
Louisville, KY
…client environments. You will combine hands-on engineering with technical leadership to strengthen security, support regulatory compliance, and help clients manage access at…
Added 13 mins ago
Clinical Lab Scientist
Veterans Affairs, Veterans Health Administration
Louisville, KY
Added 13 mins ago
U
Senior Manager AI/ML Engineering (Flex)
UPS
LOUISVILLE, KY
- From $128,172 USD / year
We are seeking a highly skilled Senior Manager AI/ML Engineering to lead the design, development, and production delivery of enterprise AI applications incorporating Generative AI, agentic…
Added 13 mins ago
Clinical Lab Scientist (Intermittent Fee Basis)
Veterans Affairs, Veterans Health Administration
Louisville, KY
Added 13 mins ago
C
Intensive Community Care Manager (RN)
ChenMed
Louisville, KY
- $36.9 to $52.7 USD / hour
The Intensive Community Care Manager (ICCM) is a Registered Nurse (RN) who works with our highest complexity patients, their primary care physicians, and other members of the care team that…
Added 13 mins ago
Technical Project Manager
Deloitte
Louisville, KY
…On larger or more complex programs, you will partner with a Program Manager or Associate Director and take ownership of defined projects or workstreams. You will also contribute to the…
Added 13 mins ago
O
Principal Technical Program Manager
Oracle
Reston, VA · Seattle, WA
- $91,000 to $209,500 USD / year
Added 25 mins ago
ATI Senior Program Analyst
Parsons Technical Services, Inc.
VA · WV
Parsons is looking for an amazingly talented Senior Program Analyst to join our team! In this role, you will provide programmatic, operational, technical, and financial analysis for…
Added 32 mins ago
Grooming Salon Manager
Petco Animal Supplies Stores, Inc.
Ellisville, MO
…excellent opportunity for experienced groomers with proven technical expertise and leadership skills who are interested in growing and developing a…
Added 32 mins ago
Groomer
Petco Animal Supplies Stores, Inc.
Tustin, CA
…additional tasks as assigned by the Grooming Salon Leader, Solutions Manager, or Store General Manager. This is an excellent opportunity for groomers with proven technical experience to…
Added 35 mins ago
E
Event Sr Technical Lead (Part-Time Casual), Audio Visual - Cliff House Maine
Encore
Cape Neddick, ME
- $17.21 to $27.53 USD / hour
- Part-time
The Sr. Technical Lead is a Mid-Tier technical Operator, focusing on small general session work, or assisting with larger general sessions. This is intended to be a bridge between technical…
Added 35 mins ago
Clinical Laboratory Scientist
Veterans Affairs, Veterans Health Administration
Augusta, ME
Added 35 mins ago
Clinical Laboratory Scientist
Veterans Affairs, Veterans Health Administration
Augusta, ME
Added 38 mins ago
Manager Mission Assurance 2
Northrop Grumman
Redondo Beach, CA · Redondo Beach
…driving continuous improvement across the supply chain to achieve program quality objectives and customer satisfaction. This position may require up to 80% of direct work for supported…
Added 38 mins ago
Sentinel Principal/Sr Principal Project Management - 18891
Northrop Grumman
Roy, UT · Roy
Northrop Grumman Defense Systems is seeking a experienced Principal/Sr Principal Project Manager. This position is located in Roy, UT and supports the Sentinel program in enhancing the US…
Added 39 mins ago
Program Operations Manager
Raydar
Washington, DC
Raydar is recruiting for this role on behalf of our client. Act as the accountable program owner for customer engagements, partnering with a technical lead and a team of engineers. Convert…

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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