Quality Manager Jobs

About The Position

Requirements

• Bachelor’s degree in Life Sciences (or equivalent experience)
• 8+ years of experience in a regulated environment (GLP/GCP roles)
• Strong working knowledge of laboratory quality systems and regulatory standards
• Demonstrated experience supporting audits, inspections, and regulatory interactions
• Proven ability to interpret regulations and develop compliant policies and procedure
• Strong regulatory interpretation and decision‑making skills
• Ability to influence cross‑functional stakeholders
• Experience leading quality system improvement
• Excellent communication and documentation skills
• Proven people leadership and team development capability

Responsibilities

• Regulatory Compliance & Inspection Readiness Provide leadership and governance for audits and inspections across CLS in alignment with ISO 15189, CAP, CLIA, NYS/MOH, and GCP requirements.
• Serve as a primary quality interface with regulatory authorities and clients during audits and inspections.
• Ensure timely escalation of compliance risks and implementation of corrective and preventive actions (CAPA) .
• Quality Systems Oversight Ensure consistent implementation, review, and governance of SOPs , policies, and controlled documents.
• Translate regulatory requirements into practical, operational quality controls .
• Maintain oversight of data integrity programs , result corrections, and documentation standards.
• Audit & Continuous Improvement Leadership Lead internal audit programs , inspection preparedness activities, and follow‑up actions.
• Analyze quality data and KPIs to drive process improvement initiatives .
• Facilitate quarterly quality metrics reviews and management reviews .
• People & Stakeholder Leadership Influence cross‑functional stakeholders to improve quality outcomes and operational efficiency.
• Provide coaching, training, and performance feedback aligned to business and regulatory needs.
• Vendor & External Oversight Support vendor qualification, oversight, and issue resolution.
• Ensure third‑party activities meet applicable regulatory and quality standards.

Benefits

• Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.
• Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only.
• Employees who are regularly scheduled to work a 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO.