Associate Director Quality Assurance

2 weeks ago

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

About Discovery Life Sciences:

Discovery Life Sciences (Discovery) is 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. We routinely manage hundreds of studies and expertly test thousands of biospecimens simultaneously. Leading biopharma, diagnostic and academic institutions trust us to quickly deliver high-quality biospecimens and reliable, reproducible biomarker data, so they can outpace their competition and push the leading edge of innovation using our Science at your Service TM business model.

Position Summary:

Discovery is looking for 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 to maximize customer satisfaction. The incumbent will support the building of a Quality-minded culture across the organization and provide strong leadership and expertise in establishing, implementing and maintaining Quality standards throughout the Company’s complete value chain.

A Day in the Life of an Associate Director of Quality Assurance at Discovery Life Sciences:

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

Position Qualifications (Education, Skills, Experience):

  • 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, GMP, ISO, FDA, and/or ICH regulations, including inspections/audits from the responsible agencies
  • Experience managing quality systems within a clinical trials lab preferred
  • Must live in or be willing to relocate to Huntsville, AL

Key Responsibilities:

  • Responsible for setting direction and execution of Quality Management System standards for assigned business units
  • Manage and oversee Noncomforming events (NCE)/corrective and preventative actions (CAPA) Program, including policies, processes, and training; directs area managers to implement the program, monitors performance of program and implements continual improvements to drive results
  • Monitor and present key Quality metrics surrounding complaints and NCE/CAPA program for Management Review to highlight and suggest areas for improvement to various department leadership
  • Oversee/host audits and inspections to maintain key accreditations to support business objectives (such as ISO, CAP/CLIA, GxP, etc.) and customer relationships
  • Train and mentor other Quality Team members
  • Serve as Discovery Quality Representative for key and strategic customer relationships to champion quality of Discovery products and services and further customer relationships
  • Create and foster an environment of continuous improvement throughout the organization; design, develop and implement quality awareness and training programs
  • Other duties as assigned by supervisor.

Compensation and Benefits:

Discovery Life Sciences is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.

Your annual salary is only one part of your total compensation package. Other benefits:

  • Competitive salary and benefits package options including free medical, dental, vision, life, and disability which start on your first day of employment. Free medical, dental and vision options for you and your Family members
  • 401(k) match program which starts on your first day of employment
  • Flexible work hours
  • Time away from work (Generous vacation and paid time off, your BIRTHDAY, 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

Location and work hours:

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

We are actively seeking motivated, dedicated individuals like you to join our thriving organization. As a leader in our industry, we offer unparalleled opportunities for professional growth and success.

Apply Now to join our team
Visit dls.com/careers for more details.

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