Location: Huntsville,AL, USA
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 inspectorsPerform internal auditsSupport lab services teams, perform document review, review SOPs, and CAPAsLead team of 2 - providing guidance, support, and developmental opportunitiesPosition Qualifications (Education, Skills, Experience):Bachelor's Degree in life sciences preferred7+ years' of quality assurance experienceLife sciences/pharmaceuticals/diagnostics industry experience requiredSome experience within Molecular biology, Genomics, Immunohistochemistry (IHC), Histology, Proteomics, or Flow Cytometry preferredKnowledge 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 preferredMust live in or be willing to relocate to Huntsville, ALKey Responsibilities:Responsible for setting direction and execution of Quality Management System standards for assigned business unitsManage 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 resultsMonitor and present key Quality metrics surrounding complaints and NCE/CAPA program for Management Review to highlight and suggest areas for improvement to various department leadershipOversee/host audits and inspections to maintain key accreditations to support business objectives (such as ISO, CAP/CLIA, GxP, etc.) and customer relationshipsTrain and mentor other Quality Team membersServe as Discovery Quality Representative for key and strategic customer relationships to champion quality of Discovery products and services and further customer relationshipsCreate and foster an environment of continuous improvement throughout the organization; design, develop and implement quality awareness and training programsOther 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 employmentFlexible work hoursTime 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 ProgramLocation 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 areaFlexible work schedule, start time between 7am and 9am local timeTravel - Up to 20% domestic travel and 5% international travel expectedWe 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.Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)