Precision Medicine Group · 20 hours ago
Director, Quality Assurance (Systems)
United States
Full-time
Remote
Director/Executive
$162K/yr - $243K/yr
10+ years expPrecision Medicine Group is a leader in the field of precision medicine, and they are seeking a Director of Quality Assurance (QA) Systems. This role is responsible for ensuring the validation, integrity, and compliance of systems, overseeing the development and implementation of QA strategies and processes that align with regulatory requirements and industry standards.
BiotechnologyHealth Care
Responsibilities
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
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
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
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
Qualification
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
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
Benefits
Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation
Company
Precision Medicine Group
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market.
1001-5000 employees
H1B Sponsorship
Precision Medicine Group 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
2025 (2)
2024 (3)
2022 (2)
2021 (1)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Mark Clein
Co-Founder & Chief Executive Officer
Matt DeZee
Chief Financial Officer
Company data provided by crunchbase