Precision For Medicine

Director, Quality Assurance – Systems

Precision For Medicine

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $162,000 - $243,000 per year

Job Level

Lead

About the role

  • The Director of Quality Assurance (QA) Systems is responsible for ensuring the validation, integrity, and compliance of systems across Precision for Medicine (PFM)
  • Oversees the development, implementation, and maintenance of QA strategies and processes that support regulatory requirements, industry standards, and internal policies
  • Leads cross-functional teams to ensure systems are validated, documented, and maintained in a state of control
  • Manage risk-based Computer System Validation planning and execution, aligned to regulatory guidelines
  • Establish and enforce QA policies and procedures for PFM systems
  • Input to the Application Development Lifecycle (ADLC) processes to represent regulated technologies
  • Serve as the primary liaison with regulatory agencies and third parties for system-related audits and inspections

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
Benefits
  • This role is also eligible for a discretionary annual bonus
  • health insurance
  • retirement savings benefits
  • life insurance and disability benefits
  • parental leave
  • paid time off for sick leave and vacation
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
computerized systems validationGxP environmentquality assuranceregulatory compliancerisk-based validation planningapplication development lifecycleaudit managementdocumentationQA strategiesprocess implementation
Soft Skills
leadershipcommunicationproblem-solvingorganizational skillsteam managementcross-functional collaborationsupervisory skillsstrategic planninginterpersonal skillsdecision-making