Director, Quality Assurance – Systems
Location
United States
Posted
52 days ago
Salary
$162K - $243K / year
Bachelor Degree10 yrs expEnglish
Job Description
• 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
Job 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
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