QA Systems and Process Manager
About The Position
The QA Systems and Process Manager provides quality assurance oversight of risk-based validation and lifecycle compliance for GxP computerized systems. The role oversees the full validation lifecycle, from initial assessment and implementation through operation, periodic review, changes, and retirement. It partners with IT, system and business owners, operational teams, and external vendors and service providers to support data integrity, audit and inspection readiness, continuous improvement, and compliance. The position provides independent, risk-based oversight of regulated computerized systems and reviews and approves validation deliverables, change controls, and continuous improvement initiatives. It supports implementation and change timelines, reporting, incident and CAPA evaluation, compliance risk escalation, documentation updates, metrics, and audit and inspection activities. The role also provides technical expertise to support the transition from Computer System Validation to Computer Software Assurance and drives issues to resolution. The role has no supervisory responsibilities and includes up to 5% travel.
Requirements
- Bachelor's degree in science or a related field and 7 years of related experience, or an equivalent combination of education and experience.
- 5 or more years of experience working on GxP-validated applications in a pharmaceutical or regulated environment.
- Experience and knowledge of quality and regulatory business processes.
- Direct hands-on experience implementing GxP computerized systems and maintaining their validated state.
- Strong process improvement skills and orientation.
- Proven business and technology skills, including success providing customer-oriented technology solutions.
- Excellent verbal, written, and presentation skills when interacting with user and technical communities.
- Ability to communicate ideas in both technical and user-friendly language.
- Collaborative approach and strong team-player skills.
- Deep understanding of applicable regulatory guidelines, including 21 CFR Part 11, EU Annex 11, ICH GCP/GLP, and data integrity principles.
- General knowledge of databases and computer networking.
- Working knowledge or experience with SaaS systems.
- Ability to work with confidential data.
- Ability to prioritize and drive for results.
Nice To Haves
- Experience or understanding of Computer Software Assurance.
Responsibilities
- Provide independent, risk-based QA oversight of GxP-regulated computerized systems for IT, Clinical Data Management, and other applicable functional systems.
- Review and approve validation deliverables, including risk assessments, validation plans and tests, user acceptance tests, test evidence, summary reports, change controls, and deviations.
- Author and execute CSV implementation plans in a timely manner, as requested.
- Develop solutions and manage project and 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 guidance and user reference documentation.
- Continuously improve monitoring and user issue handling, and deliver better value to customers.
- Support internal and external audits and inspections.
- Provide technical expertise to enable the transformation from Computer System Validation (CSV) to Computer Software Assurance (CSA).
- Drive issues to resolution.
- Perform other duties as assigned and comply with all policies and standards.
Benefits
- 401(k) plan with generous company contributions
- Group medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Flexible spending accounts
- Discretionary annual bonus program, or a sales-based incentive plan for field sales staff
- Opportunity to purchase company stock
- Long-term incentives
- 15 accrued vacation days in the first year
- 17 paid holidays, including a company-wide winter shutdown in December
- Up to 10 sick days throughout the calendar year
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
