Associate Director, QAV IT CSA/CSV

Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market.

At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time.

Position Summary

The Associate Director, QAV CSA provides comprehensive Quality Assurance oversight for GxP computerized systems across Minaris. Will be responsible for managing and approving CSV/CSA activities, ensuring alignment with global QA and Compliance programs, and supporting data integrity initiatives. The position acts as the single point of contact for quality in driving the implementation of unified CSV and CSA processes, with risk-based models to validation activities. In addition, the role supports vendor qualification, manages contractors, and leads training programs related to computerized systems compliance. Additional duties include collaborating on audits and inspection readiness, maintaining global validation strategy, supervising staff, and ensuring all CSV/CSA activities follow regulatory requirements and internal procedures

Essential Functions and 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.

Leadership Responsibility

• Accountability: Accountable for ensuring all CSV/CSA activities comply with GMP, regulatory requirements, and internal quality standards.
• Integrity: Maintains the highest ethical standards in all GxP and operational activities. Ensures accuracy, honesty, and transparency in documentation, decision-making, and communication. Drives a culture where compliance, accountability, and doing the right thing are non-negotiable.
• Continuous Improvement: Drive continuous improvement of CSV/CSA processes to enhance efficiency, consistency, and compliance. Identify opportunities to streamline validation activities using risk-based and lifecycle-based approaches.
• Strategy & Harmonization: Assesses and improves capabilities and procedures; drives harmonization.
• Regulatory Compliance: Ensures all ] activities meet regulatory standards (GMP) and oversees related documentation.
• Risk Management: Identifies and mitigates risks related to CSV/CSA processes, equipment, and products in collaboration with SMEs.
• Communication & Customer Focus: Fosters transparent communication and strong customer relationships with a focus on delivering solutions.
• Adaptability & Integrity: Comfortable with ambiguity, adapts to change, and upholds ethical standards and confidentiality.
• Decision-Making: Operates with a level of autonomy and demonstrates strong decision-making skills to cultivate Right the First Time Quality Culture.

Knowledge, Skills & Ability

• 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.

Education & Experience

• 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.

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.

The estimated base salary range for each open position based in the United States of America is included for all our current openings. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) as part of the compensation package. Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.