About the Role: The Quality Assurance Manager provides day-to-day leadership for key Quality Management System (QMS) processes and the Quality team, ensuring continued suitability, compliance, and scalability of the QMS as the business grows. This role is accountable for oversight and effectiveness of change control, Computer System Validation (CSV), including validation of GxP-relevant software, AI-assisted/low-code/no-code tools, and native-built applications, risk management, supplier/vendor quality, deviation/complaint handling, CAPA, internal auditing, and training. The QA Manager partners cross-functionally to drive a culture of quality, proactive risk management, and continuous improvement.
Primary Responsibilities:The Quality Assurance Manager provides day-to-day leadership for key Quality Management System (QMS) processes and the Quality team, ensuring continued suitability, compliance, and scalability of the QMS as the business grows. This role is accountable for oversight and effectiveness of change control, Computer System Validation (CSV), including validation of GxP-relevant software, AI-assisted/low-code/no-code tools, and native-built applications, risk management, supplier/vendor quality, deviation/complaint handling, CAPA, internal auditing, and training. The QA Manager partners cross-functionally to drive a culture of quality, proactive risk management, and continuous improvement.
Primary Responsibilities:Leadership & QMS Governance
- Lead and develop QA staff through coaching, workload prioritization, performance feedback, and training plans.
- Own assigned QMS processes end-to-end, ensuring procedures are current, effective, and aligned to applicable FDA/ISO expectations.
- Promote organizational awareness of the Quality System; deliver and/or coordinate quality training, tools, and best practices.
- Establish quality objectives and key performance indicators (KPIs); compile, trend, and report quality metrics and corrective actions.
- Facilitate or contribute to management review inputs (e.g., KPI trends, audit outcomes, CAPA effectiveness, and risk status).
Quality Operations (Change Control, CSV/Validation, Risk, CAPA, Complaints)
- Provide oversight to change control to ensure appropriate impact assessments, risk evaluations, approvals, implementation, and effectiveness checks.
- Oversee systems/process validation activities, including Computer System Validation (CSV), to ensure fit-for-purpose controls, compliant documentation, data integrity, and sustainable lifecycle management of regulated and quality-impacting tools.
- Oversee risk-based CSV activities for GxP-relevant software, spreadsheets, databases, workflow tools, AI-assisted applications, low-code/no-code solutions, and native-built applications, including intended use assessment, risk assessment, traceability, testing, deviation handling, and validation summary reporting.
- Lead investigations for deviations, nonconformances, and complaints; ensure root cause analyses are rigorous, timely, and appropriately documented.
- Own or oversee CAPA lifecycle management, including initiation, action planning, implementation, and verification of effectiveness.
- Engineer solutions to address product, data, and process quality issues; drive continual improvement projects and standardization across teams.
Document Control & Training
- Ensure document control processes are followed for creation, review, approval, issuance, change, and archival of controlled documents.
- Support and strengthen the training program: define role-based curricula, coordinate training events, and monitor completion and effectiveness.
- Maintain and/or oversee maintenance of training records to ensure audit-ready documentation.
Audits & Inspection Readiness
- Plan and execute internal audits; manage the annual audit program and ensure timely closure of audit findings.
- Host, co-host, and support client audits; coordinate readiness activities and ensure responses are accurate, complete, and on-time.
- Conduct or oversee supplier/vendor audits and qualification activities; ensure supplier performance is monitored and issues are escalated and resolved.
Cross-Functional Partnership
- Partner with Operations, Clinical/Research, Product/Engineering (as applicable), and leadership to integrate quality into daily execution and decision-making.
- Provide quality guidance during process development, supplier selection/management, and implementation of new tools or workflows, including AI-assisted, low-code/no-code, and native-built applications used in quality or operational processes.
- Partner with Product/Engineering and business stakeholders to define fit-for-purpose validation controls, change management expectations, and lifecycle oversight for internally developed applications and automation tools.
- Communicate quality risks clearly to stakeholders; escalate emerging issues and recommend pragmatic, compliant paths forward.
Position Requirements:- Bachelor's Degree in Biology, Chemistry, Life Sciences, Engineering, or related field (required).
- 8+ years of experience in quality supporting clinical research and/or pharmaceutical/biotech development; advanced degree may substitute for a portion of experience.
- 3+ years of experience leading others (people leadership, team lead, or mentorship/accountability for work output).
- Demonstrated expertise in QMS processes: change control, deviations/nonconformances, complaints, CAPA, risk management, supplier quality, audits, and training.
- Demonstrated experience with Computer System Validation (CSV) in a regulated environment, including risk-based validation of software, spreadsheets, SaaS platforms, and workflow tools.
- Experience validating AI-assisted, low-code/no-code, and native-built applications, with the ability to assess intended use, system risk, testing rigor, data integrity, and change control requirements.
- Experience compiling and trending quality metrics and driving data-based continuous improvement.
- Strong working knowledge of FDA and ISO concepts relevant to the organization; ability to interpret requirements and translate them into practical processes.
- Working knowledge of 21 CFR Part 11, electronic records/electronic signatures expectations, and risk-based validation approaches for digital systems.
- Regulatory/quality certifications (ASQ/SQA) and/or Lean/Six Sigma (Green Belt/Black Belt) preferred; active continuing education a plus.
- Strong computer literacy, excellent written and verbal communication skills, and strong organizational/time management skills.
- Comfortable operating with autonomy, influencing without authority, and making sound quality judgments under time constraints.
Salary: $110,000 to $115,000 annually plus an annual performance based bonus
