Associate Director Quality Assurance
hace 14 días
Huntsville
Job 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: The Associate Director Quality Assurance is responsible for maintaining, monitoring, and ensuring adherence to the Quality Management System (QMS) across the specialty lab services business division of Discovery Life Sciences in compliance with GCP, GCLP, CAP/CLIA, and ISO 13485. Applies fit-for-purpose and risk-based quality principles to ensure processes, controls, and documentation are appropriate, efficient, and aligned with both scientific intent and regulatory requirements. This individual will champion quality efforts as part of the Global Quality & Regulatory team ensuring Discovery’s services and processes meet established standards, enterprise goals, and customer requirements. A Day in the Life of Associate Director of Quality Assurance at Discovery Life Sciences: • 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. Must-Have Qualifications (Education, Skills, Experience): • 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. Some prior experience with Smartsheet would be beneficial. Key Responsibilities: • Audits, • Conduct internal audits, prepare audit reports, and drive follow-up activities including CAPA plan development and closure., • Coordinate inspection readiness for sponsor/customer audits and support health authority or accrediting/certification body inspections. Actively host audits to maintain key accreditations, ensure successful lab qualifications by sponsors, and strengthen business relationships., • Draft or review audit responses as appropriate, manage CAPAs resulting from audits, and communicate in a timely manner with auditors., • Direct and train team members on audit responsibilities., • Quality Management, • Accountable for the day-to-day management of assigned global quality processes, ensuring consistent application, effective collaboration, timely completion of process activities, alignment with global quality expectations, and ongoing continuous improvement., • Maintain, monitor, and ensures adherence to the company-wide Quality Management System (QMS) compliant with GCLP, CAP/CLIA, and ISO 13485 and other applicable regulatory requirements., • Foster an environment of continuous improvement throughout the organization; including the design, development, and implementation of quality awareness and training programs., • Support the NCE/CAPA program, including hands-on execution or oversight of quality personnel in evaluating NCEs and developing and completing CAPA plans., • Review and approve laboratory and quality related documentation such as analytical plans, validation reports, SOPs and templates., • Participate in supplier qualification and management., • Risk Management, • Conduct and document risk assessments that guide risk-based decisions on audit cadence and other quality activities, ensuring intervals and risk-level determinations are appropriately justified and aligned with quality expectations., • Collaborate with teams to complete risk-related forms and ensure proper documentation., • Review risk management documentation for compliance with procedures and standards., • Metrics, • Routinely monitor and provide key quality metrics in a timely fashion for quarterly/periodic review and the annual Management Review., • Analyze trends and propose areas for improvement to department leadership., • Other, • Prepare materials and deliver training sessions to quality teams, laboratory personnel, and other relevant groups., • Provide frequent and concise quality updates, actively maintaining lines of communication with management and stakeholders., • Additional duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here., • Routine and predictable attendance/travel to the site is an essential function of the role., • This position is onsite at Discovery’s headquarters in Huntsville, AL or remote. 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. For this role, the anticipated base pay range is $100,000 - $140,000 annually. The exact base pay offered for this role will depend on various factors, including the candidate's qualifications, skills, and experience. Your annual salary is only one part of your total compensation package. Other benefits include: • 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. Location, work hours, and application details: • Huntsville, AL OR Remote (US), • Flexible work schedule, start time between 7am and 9am eastern or central time, • Up to 20% domestic travel required for mandatory site meetings, audits, and trainings 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. The Discovery Life Sciences Talent Acquisition team proudly manages and represents all Discovery recruitment activities. We respectfully request that third party staffing agencies refrain from submitting candidates or soliciting meetings to discuss recruiting services. We are unable to sponsor or take over sponsorships of any applicant work visas at this time.
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