Discovery Life Sciences

Associate Director, Quality Assurance

Discovery Life Sciences

full-time

Posted on:

Location Type: Remote

Location: Remote • Alabama • 🇺🇸 United States

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Salary

💰 $100,000 - $140,000 per year

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • 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.

Applicant Tracking System Keywords

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

Hard skills
Quality Management Systems (QMS)GxP complianceComputerized Systems Validations (CSVs)Flow CytometryGenomicsProteomicsImmunohistochemistryNCEsCAPAsregulatory compliance
Soft skills
communicationcoachingorganizational skillsattention to detailproject managementleadershiptrainingrisk managementstakeholder engagementteam management