Associate Director, QA Computer System Validation
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Job Description
Associate Director overseeing QA CSV activities for GxP computerized systems in a biopharmaceutical company. Ensuring compliance with regulatory standards and providing QA leadership.
Responsibilities:
- Provide QA oversight and support business and CSV activities throughout the lifecycle of GxP computerized systems.
- Review and approve CSV deliverables, IT change management requests, and quality records (e.g., NCRs CAPAs) to ensure adherence to 4DMT’s internal procedures and policies, and applicable regulatory requirements and standards.
- Review plans and provide day-to-day QA guidance and support to initial validation, steady state activities and controlled change-related initiatives of GxP systems.
- Serve as a subject matter expert (SME) in CSV requirements, data integrity controls, and related regulatory requirements / standards, including FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable ICH Guidelines.
- Develop and/or refine QA and CSV-related procedures and templates.
- Support audits for qualification and requalification of IT vendors.
- Collaborate across functions and within Quality to identify areas of improvement and implement enhancements.
- Support inspection readiness initiatives, audits and regulatory inspections.
- Other duties as assigned.
Requirements:
- Bachelor’s degree in life sciences, business or related field.
- 9+ years of experience within the biopharmaceutical industry, preferable in both large and small company environments.
- 6+ years’ experience in QA CSV.
- Thorough working knowledge of computer systems validation and computer software assurance.
- Expertise in 21CFRPart11 and EU Annex 11 regulations, data integrity and GAMP 5 concepts, application and best practices.
- Hands-on experience in implementing and maintaining data integrity controls.
- Experience supporting regulatory inspections and audits.
- Demonstrated ability to apply risk-based approaches to information system selection, testing, implementation and maintenance.
- Experience working with all levels of management and consulting with key business stakeholders.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors.
- Excellent written and verbal communication skills; strong interpersonal skills.
Benefits:
- Equal employment opportunities without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and other protected categories
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