QA Systems and Process Manager

Regulatory Jobs; Alameda (CA); On-site; USD 145,000 - 184,000; Full time

Benefits offered by this job

401k with company contributions

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Job summary

Exelixis in Alameda, CA seeks a QA Process and Systems Manager to oversee risk-based validation and lifecycle compliance of GxP computerized systems. You will partner with IT, system owners, business units and external vendors to ensure data integrity, audit readiness, and continuous improvement.

Responsibilities include approving validation deliverables, authoring CSV implementation plans, managing change controls, and generating metrics to support business goals.

Qualifications

• 7+ years of related experience in regulated environments.
• Experience with GxP validated applications.
• Knowledge of 21 CFR Part 11, EU Annex 11, ICH GCP/GLP.

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 CSV implementation plans in a timely manner
• Develop solutions and manage project/change timelines, as requested
• Create and run reports, track follow-up actions and ensure data quality and compliance
• Support activities for internal and external audits/inspections

Skills

QA oversight

GxP knowledge

Regulatory processes

Data integrity

Cross-functional collaboration

Excellent communication

Education

Bachelor's degree in science or related field

Equivalent combination of education and experience

7 years of related experience

Tools

CSV/CSA tools

Validation tools

SaaS systems

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 escalation 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, 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: [e-mail].

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.