Associate Director Quality Assurance

4 weeks ago


Huntsville, Alabama, United States Discovery Life Sciences LLC Full time
Job Description

About Discovery Life Sciences:

We are a leading provider of highly characterized human biospecimens and cellular starting materials to advance cell and gene therapy and precision medicine programs for cancer, infectious disease, and other complex conditions.

Our team routinely manages hundreds of studies and expertly tests thousands of biospecimens simultaneously. We work with leading biopharma, diagnostic, and academic institutions to deliver high-quality biospecimens and reliable, reproducible biomarker data.

Position Summary:

We are seeking a talented and passionate Associate Director of Quality Assurance to oversee our global Quality Management System (QMS) for clinical grade services. This leader will support compliant operations, foster continuous quality improvement, and maximize customer satisfaction.

A Day in the Life:

  • Host external auditors and inspectors
  • Perform internal audits
  • Support lab services teams, perform document review, review SOPs, and CAPAs
  • Lead a team of 2, providing guidance, support, and developmental opportunities

Key Responsibilities:

  • Set direction and execution of Quality Management System standards for assigned business units
  • Manage and oversee Nonconforming events (NCE)/corrective and preventative actions (CAPA) Program
  • Monitor and present key Quality metrics surrounding complaints and NCE/CAPA program for Management Review
  • Oversee/host audits and inspections to maintain key accreditations
  • Train and mentor other Quality Team members
  • Serve as Discovery Quality Representative for key and strategic customer relationships
  • Create and foster an environment of continuous improvement throughout the organization

Requirements:

  • Bachelor's Degree in life sciences preferred
  • 7+ years' of quality assurance experience
  • Life sciences/pharmaceuticals/diagnostics industry experience required
  • Some experience within Molecular biology, Genomics, Immunohistochemistry (IHC), Histology, Proteomics, or Flow Cytometry preferred
  • Knowledge and demonstrated previous management of Quality systems, CLIA, CAP, GLP, ISO, FDA, and/or ICH regulations
  • Experience managing quality systems within a clinical trials lab preferred
  • Must live in or be willing to relocate to Huntsville, AL

Benefits:

  • Competitive salary and benefits package options
  • 401(k) match program
  • Flexible work hours
  • Time away from work (vacation and paid time off, paid parental leave, paid family leave)
  • 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

Location and Work Hours:

  • Hybrid – Must live in or be willing to relocate to Huntsville, AL. 3 days per week onsite, 2 days remote
  • Relocation assistance will be provided for the selected candidate relocating to the Huntsville, AL area
  • Flexible work schedule, start time between 7am and 9am local time
  • Travel – Up to 20% domestic travel and 5% international travel expected


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