Director, Quality Assurance (Systems)

Precision for Medicine

1d•Remote

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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.