Associate Director - Computer Systems Validation
Brand Description
The leader of Computer System Validation and Computer Software Assurance (CSV/CSA) is responsible for leading and governing all site-wide CSV and CSA activities to ensure that computerized systems are validated, compliant, and maintained in accordance with GMP regulations, 21 CFR Part 11, and global quality standards.
Key Objectives/Deliverables
Manage for Results / Strategic Planning: Lead and develop a high performing, site-wide CSV/CSA team responsible for validation execution, inclusive of resource planning, skill building, training, and inspection readiness.
Define and maintain the site-wide CSV/CSA strategy for information technology (IT) and operational technology (OT) policies and procedures aligned with site, global, and regulatory expectations.
Maintain and implement an annual technical continuous improvement and asset qualification monitoring (AQM) agenda.
Oversee execution of validation activities across all GMP systems, including: supporting risk assessments based on system criticality and data impact, validation planning and test execution (IQ/OQ/PQ), and traceability / documentation completeness.
Ensure all computerized systems remain in a validated state throughout their lifecycle.
Partner with QA to maintain compliance with data integrity, audit trail, and security requirements consistent with regulatory expectations (GAMP 5, EU Annex 11, 21 CFR Part 11, etc.).
Lead regulatory inspection readiness for CSV/CSA and support inspection activities.
Ensure effective handover between project and operational phases of computerized systems.
Influence internal and external customers/regulators/partners, including to adopt a different point of view on difficult concepts.
Partner with key stakeholders to harmonize validation approaches and incorporate regulatory feedback.
Benchmark through industry consortia and conferences.
Provide representation where required for cross-functional and cross-site technical initiatives.
Basic Requirements
Experience performing qualification of manufacturing automated equipment and computerized systems.
Understanding of FDA and EU regulations and guidelines and knowledgeable of current industry trends.
Organizational and time management skills that will allow for effective prioritization of activities.
Understanding of key data integrity principles to ensure requirements are aligned to appropriate testing strategies with the use of electronic data / databases.
Broad knowledge of computer systems and automated process equipment or utility systems, such as Rockwell (PLC/HMI), MES, ERP, and OSI PI.
Strong communication skills, both oral and written to effectively communicate technical information in a clear and concise manner within a GMP environment.
Strong analytical, problem solving, and excellent interpersonal skills.
Additional Preferences
Prior leadership experience preferred.
Education Requirements
Bachelor’s degree in engineering, science, or related discipline with a minimum of 5 years’ experience in cGMP biopharmaceutical manufacturing.
Pay
$135,000 - $180,000
Schedule
This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.
Benefits
Paid time off (holidays, vacation, and additional leave)
Medical, dental, and vision insurance
Life insurance
A company-matched retirement savings plan
Wellness programs
Short- and long-term disability benefits
Qualifications
Up to 10% travel
On-call availability
May involve shift work
Hybrid work flexibility may be available based on business needs
No relocation assistance provided
Skills
Leadership
Quality Assurance
Data Integrity
Computer Systems Validation
Regulatory Compliance
Collaboration
Project Management
Technical Writing
Benefits
Comprehensive benefits package