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Discovery Life Sciences · 1 day ago

Associate Director Quality Assurance

United States

Full-time

Onsite

Lead/Staff, Director/Executive

$100K/yr - $140K/yr

Discovery Life Sciences is a leading provider of highly characterized human biospecimens and cellular starting materials. The Associate Director Quality Assurance is responsible for maintaining and ensuring adherence to the Quality Management System across the specialty lab services division, applying quality principles to ensure compliance with regulatory requirements.

BiopharmaBiotechnologyClinical TrialsMedical

No H1B

Responsibilities

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

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

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

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

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

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

Qualification

Quality Management Systems (QMS)GCPGCLPCAP/CLIAISO 13485Internal auditsAnalytical technology experienceGxP compliant document managementComputerized Systems ValidationsProject managementMicrosoft Office proficiencyAttention to detailOrganizational skillsCommunication skills

Required

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

Strong attention to detail, excellent organizational skills, and the ability to manage competing priorities

Proficiency with Microsoft Excel, Word, PowerPoint, and Outlook

Preferred

Previous regulatory experience is a plus

Some prior experience with Smartsheet would be beneficial

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.

Company

Discovery Life Sciences

Discovery Life Sciences, the Biospecimen and Biomarker Specialists™, is a leading provider of highly characterized human biospecimens and cellular starting materials integrated with expert multi-omic analytical services to advance cell and gene therapy and precision medicine programs for cancer, infectious disease, and other complex conditions.

Founded in 2006