The Associate Director Quality Assurance is responsible for maintaining, monitoring, and ensuring adherence to the Quality Management System (QMS) across the specialty lab services business division of Discovery Life Sciences in compliance with GCP, GCLP, CAP/CLIA, and ISO 13485. Applies fit-for-purpose and risk-based quality principles to ensure processes, controls, and documentation are appropriate, efficient, and aligned with both scientific intent and regulatory requirements.
Requirements
- Strong working knowledge of Quality Management Systems (QMS) and applicable regulations and standards, including FDA and ICH requirements, EU Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), CAP/CLIA, GCP, GCLP, and ISO 13485.
- Proven ability to interpret and apply these standards effectively to ensure compliant, fit-for-purpose, and risk-based quality processes.
- Familiarity with one or more advanced analytical technology areas (e.g. Flow Cytometry, Genomics, Proteomics, or Immunohistochemistry), acquired through direct laboratory experience or quality support of specialty/translational sciences labs.
- Prior management of internal audit programs and external audit activities, whether performing audits or preparing for and hosting sponsor, third-party, or health authority inspections.
- Experience managing direct reports and matrixed teams across one or more sites.
- Ability to clearly communicate complex quality principles to diverse stakeholders.
- Experience with GxP compliant document management systems (e.g. Veeva, MasterControl, MediaLab) to ensure version control, controlled workflows, and audit trails.
- Demonstrated proficiency in one or more of the following areas: Computerized Systems Validations (CSVs), NCEs, deviations, investigations/root cause analysis, & CAPAs, Training and competency management, ensuring personnel are appropriately trained, qualified, and assessed, Project management skills, including planning, coordination, and execution of complex initiatives.
- Previous regulatory experience is a plus.
- Strong attention to detail, excellent organizational skills, and the ability to manage competing priorities.
- Proficiency with Microsoft Excel, Word, PowerPoint, and Outlook. Some prior experience with Smartsheet would be beneficial.
Benefits
- Competitive salary and benefits package options, including a free dental, vision package, life insurance, and disability coverage which start on your first day of employment.
- Performance-based incentive compensation, which may include cash bonus(es).
- 401(k) match program which starts on your first day of employment.
- Time away from work (Generous vacation and paid time off, paid parental leave, paid family leave, etc.).
- Professional development opportunities and reimbursement for relevant certifications.
- Collaborative and inclusive work environment that values diversity.
- Team-building activities and social events.
- Employee Referral Program and Colleague Recognition Program.
