Associate Director, Quality Assurance
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Job Description
Associate Director Quality Assurance overseeing QMS compliance across specialty lab services at Discovery Life Sciences. Leading audits, managing quality team, and ensuring adherence to regulations.
Responsibilities:
- Oversee daily execution of global document management processes, ensuring compliance with GCLP, CAP/CLIA, ISO 13485, and customer requirements.
- Lead internal audits and support sponsor/customer inspections.
- Partner with laboratory and cross-functional teams to apply risk-based, fit-for-purpose quality principles to specialty lab operations.
- Coach and develop quality team members, deliver training, and communicate quality updates to leadership and stakeholders.
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.
- Requires 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) including planning, execution, documentation, and ensuring compliance with regulatory requirements (e.g. 21 CFR part 11, GxP).
- 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.
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.
- This role is also eligible to earn performance-based incentive compensation, which may include cash bonus(es). These incentives are discretionary.
- 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.
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