Director, Quality Assurance (Systems)

Position Summary:

The Director of Quality Assurance (QA) Systems is responsible for ensuring the validation, integrity, and compliance of systems across Precision for Medicine (PFM). This role oversees the development, implementation, and maintenance of QA strategies and processes that support regulatory requirements, industry standards, and internal policies. The Director will lead cross-functional teams to ensure systems are validated, documented, and maintained in a state of control, enabling consistent compliance with global quality standards.

While working closely with the Technical Services team, the Director QA Systems reports to the VP, Global Quality Assurance – Translational Sciences.

Essential functions of the job include but are not limited to: 

System Validation & Compliance

• Oversee the PFM risk-based Computer System Validation planning and execution (e.g., Validation Plans, Requirements Traceability Matrix, IQ/OQ/PQ, UAT), aligned to 21 CFR Part 11, EU Annex 11, ICH E6(R3) GCP, GLP, and data integrity principles (ALCOA++).

• Ensure all computerized systems are validated according to internal SOPs and regulatory expectations.
• Maintain a robust risk-based approach to system validation and lifecycle management by assuring periodic review, change control, configuration management, and release readiness for validated systems.
• Supports lifecycle controls from implementation through decommissioning.

Quality Governance

• Establish and enforce QA policies and procedures for PFM systems. Provides input to the Application Development Lifecycle (ADLC) processes to represent regulated technologies
• Monitor compliance trends and implement continuous improvement initiatives.
• Serve as the primary key liaison with regulatory agencies and third parties for system-related audits and inspections.
• Supports the maintenance of inspection ready validation documentation

Leadership & Collaboration

• Partner with Security, Development, PMO, BRM, Business Analysts, DevOps, Clinical Ops, and Lab leaders to prioritize QA activities and embed quality into SDLC/DevOps pipelines
• Act as a key liaison with regulatory agencies during inspections related to corporate systems.
• Deliver training and coaching on validation, testing, and data integrity for system owners and study teams
• Partake to the qualification of data/system service providers

Documentation & Reporting

• Ensure accurate and timely documentation of validation activities, deviations, and corrective actions.
• Provide regular compliance reports and metrics to senior leadership.
• Maintain audit readiness for all corporate systems.
• Collaboratively work with IT to respond to audit findings.

Qualifications: 

Minimum Required:

• Requires 10 years of experience in clinical research with emphasis in Quality Assurance / Compliance
• Strong knowledge of computerized systems validation (CSV)
• Experience working on CSV activities in a GxP environment
• Strong knowledge of ICH guidelines, 21 CFR Part 11, EU Annex 11 and OECD guidelines.
• Supervisory/management experience leading quality personnel
• Proven leadership experience managing QA teams and cross-functional projects.
• Excellent communication, problem-solving, and organizational skills.

Other Required:

• Bachelor’s degree in a science, healthcare or related field of study
• Availability to travel up to 25% domestically and/or internationally
• Experience leading audits

Preferred:

• Graduate, postgraduate degree, ideally in a scientific or healthcare discipline
• CRO, Pharmaceutical and/or medical device experience
• Experience hosting client/Health Authority inspections

Skills:

• Strong leadership skills, excellent interpersonal and problem-solving skills, strong verbal and written communication, excellent computer skills
• Clinical project proposals and budget forecasting

Competencies:

• Ability to effectively communicate across the organization on quality topics
• Represents Quality in sponsor discussions
• Resolves project related problems and prioritize workload to meet deadlines with little support from management
• Exhibits high self-motivation and can work and plan independently as well as in a team environment
• Motivates other members of the project team to meet timelines and project goals
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
• Proven ability to communicate with senior management, external thought-leaders and operational staff
• Ability to work with cross functional groups and management under challenging situations
• Ability to prioritize work and handle multiple and/or competing assignments
• Excellent verbal and written communications skills

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