Minaris Advanced Therapies · 3 hours ago
Associate Director, QAV IT CSA/CSV
Allendale, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
15+ years expMinaris Advanced Therapies is a global leader in cell and gene therapy development, manufacturing, and testing. The Associate Director, QAV CSA provides comprehensive Quality Assurance oversight for GxP computerized systems, managing CSV/CSA activities and ensuring compliance with regulatory requirements while supporting data integrity initiatives.
BiotechnologyHealth CareManufacturing
Responsibilities
Provide oversight of CSV/CSA activities associated with GMP manufacturing and laboratory instruments/equipment, utilities and facilities
Review/audit and/or approve key Software Develop Life Cycle validation deliverables and change management deliverables for computerized systems within Minaris
Provide impact assessment to changes and deviations, failure Investigation and CAPAs associated with GxP computer systems (operational changes according change control process)
Collaborate with the local and global IT to ensure alignment with QA/e-Compliance programs and deliverables. Ensure the equipment/system interface with local and global IT systems is appropriately designed, installed and tested
Act as a SPOC (single point of contact) for Quality Assurance/e-Compliance on assigned computerized systems initiatives
Support the development and drive the implementation of the Minaris QA/e-Compliance strategy and one CSV process in line with the Minaris quality and regulatory requirements to ensure effective and compliant quality oversight over Minaris GxP computerized systems
Integrate appropriate risk-based models for CSV/CSA activities of GxP systems within Minaris
Ensure integration of timely QA/e-Compliance participation in the Minaris project & operational activities
Support implementation of all Data Integrity deliverables as defined by Minaris
Support the development of and provide adequate quality input into all IT-related vendor selection, qualification and management processes and systems. Manage external contractors, as necessary
Acts independently to create, implement, and maintain site CSV/CSA compliance training program and provides the necessary training to develop site staff
Support in cooperation with Group GxP Training, the development and delivery of training relevant for Quality, IT and business functions in the area of computerized systems compliance
Collaborate with Group Compliance and Auditing to monitor audit observations related to GxP computerized systems and computer system validation to ensure gaps are identified and adequately addressed
Lead ongoing audit and inspection readiness in close collaboration with Minaris
Under the direction of the Head, Global QA Validation acts to create, implement and maintain up-to-date the Global validation compliance program and strategy
Supervise full time staff and contractors assigned to CSV/CSA projects ensuring efficiency, consistency, quality of work and compliance with external regulations and internal procedures
Collaborate with the IT Delivery Team, business users and internal Global Quality compliance staff to ensure that CSV/CSA activities are planned and executed in accordance with internal procedures
Qualification
Required
Excellent understanding (mandatory) of 21 CFR Part 11, EU Annex 11, Data Integrity principles, GAMP methodologies and Agile methodologies
Excellent knowledge of IT applications, IT infrastructure, architecture of computer systems including SaaS, networks, operating systems, databases, and software tools
Excellent knowledge (mandatory) of IT testing practices and methodologies in the Pharma GxP space-and good working knowledge of tools like Service Now and Application Lifecycle Management (ALM)
Excellent English Oral and written communication skills including the ability to deliver clear and articulate presentations
Minimum Bachelor's Degree in Computer Science, Chemistry, Biochemistry, Microbiology, or a related scientific discipline, advanced degree preferred but not required
15+ years of experience in the pharmaceutical, biotechnology, or related industry, with 10+ years in Quality Assurance role in Computer System Validation / Computer System Assurance, or Information Technology CSV roles
Benefits
Medical insurance
Vision insurance
Dental insurance
401(k)
Paid time off
Tuition assistance
And more.
Company
Minaris Advanced Therapies
Minaris Advanced Therapies is a global cell and gene therapy (CGT) CDMO and a multimodality biosafety testing provider.
1001-5000 employees
H1B Sponsorship
Minaris Advanced Therapies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2025-01-07Acquired
Leadership Team
William Burckardt
Chief Financial Officer, North America
Enid Agosto
Senior Administrative Assistant to CFO and Head of People & Organizational Development
Recent News
Seattle TechFlash
2025-08-18
2025-07-22
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