Quality Assurance Manager-GXP Computer Systems

Essential Duties and Responsibilities

• Provide QA leadership for GXP computer systems and assures a risk-based methodology to validation / qualification efforts in compliance with 21 CFR Part 11, GAMP 5 and Civica Policies and Procedures.
• Support the overall readiness of the CSV program and computer-related systems to ensure software programs are compliant and ready for audits and regulatory inspections.
• Review / assess proposed GXP-related computer system change controls, investigations, CAPA, periodic reviews of GXP systems and system access in alignment with procedures to ensure compliance.
• Review and approve validation plans, protocols, reports and other verification / validation related documentation for GXP computer systems.
• Assess systems for data integrity and compliance with regulatory expectations including assessment of third-party IT service suppliers and applications.
• Participate in and support the external audit program for vendors related to GXP computerized systems.
• Provide QA guidance in the development and revision of GXP computer system procedures.
• Participate in cross-functional project teams in support of GXP computer system compliance.
• Work in collaboration with the system owners and administrators, to address priorities for programs and changes to GXP Computer system configuration, security, security profiles and any required migration plans for compliant implementation in alignment with organizational processes.
• Perform quality support duties including implementation, maintenance, and execution of quality management system processes in the Veeva.
• Provide ongoing Quality support, advice, and guidance to GXP related System Owners and System Administrators.
• Effectively manage priorities, multiple projects and ability to communicate with all levels of personnel.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelors Degree in Scientific discipline, Computer Science, or Information Technology. Masters preferred.
• 8+ years of relevant progressive experience, preferably within the pharmaceutical / biotech industry
• Comprehensive expertise and working knowledge of GXP requirements including 21 CFR Parts 11, Data Integrity, ISPE GAMP 5 and related standards and guidance documents.
• Preferred experience in validation for SaaS systems.
• Must have proven business and technology skills, with success providing customer-oriented technology solutions environment.
• Advanced skill level with Microsoft Office, especially Excel, Word, PowerPoint, and Outlook .
• Excellent verbal and written communication skills.
• Ability to read, understand, and follow complex instruction.
• People-oriented - enjoys interacting with people and working on group projects .
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• This is a remote role with occasional travel required (
30+ days ago