Qa Manager Jobs

About The Position

Requirements

• Bachelor's degree in science or a related field and 7 years of related experience, or an equivalent combination of education and experience.
• At least 5 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 for interacting with user and technical communities.
• Ability to communicate ideas in both technical and user-friendly language.
• Collaborative approach and strong teamwork 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 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 functions.
• 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 to deliver better value to customers.
• Support internal and external audits and inspections.
• Provide technical expertise to enable transformation from Computer System Validation (CSV) to Computer Software Assurance (CSA).
• Perform other duties as assigned and comply with all policies and standards.

Benefits

• 401(k) plan with generous company contributions
• Medical, dental, and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Eligibility for a 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