Sr. QA Computer System Validation Mgr.

Major Duties & Responsibilities

• Provide QA oversight to support business and CSV activities throughout the lifecycle of GxP computer systems
• Provide Quality oversight of GxP computerized systems not directly managed by 4DMT, including systems operated, hosted, or maintained by external partners or vendors, and review and approve CSV deliverables in adherence to applicable vendor or external partner procedures
• 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 and steady state activities and controlled change-related initiatives of GxP systems with focus on clinical systems
• Serve as 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
• Aid in development and/or refined 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 improvements and implement enhancements
• Support inspection readiness initiatives, audits and regulatory inspections
• Other duties as assigned or reassigned as needed by management

Qualifications

• Education: Bachelor’s degree in life sciences, computer science, business or related field
• Experience: Minimum 5-7 years of experience within the biopharmaceutical industry, preferable in both large and small company environments
• Minimum 4 years experience in QA CSV
• Strong experience supporting computer systems used in clinical trials through all phases of development
• Extensive experience supporting the validation of clinical systems (e.g. IRT, EDC, eTMF)
• Thorough working knowledge of computer systems validation and computer software assurance
• Expertise in ICH guidelines, 21CFR Part 11 and EU Annex 11 regulations, data integrity and GAMP 5 concepts, application and best practice
• 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
• Travel: As needed, less than 5%
• Physical Requirements and Working Conditions: Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met