Supervisor QA Compliance and Oversight

About the role

The Supervisor II, Compliance & Oversight leads Quality Assurance Oversight personnel who provide independent, real‑time quality oversight of GMP operations throughout process execution. This position ensures consistent application of quality and compliance requirements across manufacturing, packaging, warehouse, laboratory, and support operations, including on‑the‑floor batch record review, operational monitoring, area audits, and quality risk identification.

Responsibilities

• Provide leadership and direction to Compliance & Oversight personnel responsible for real‑time QA oversight of manufacturing, packaging, warehouse, laboratory, and support operations during process execution.
• Manage daily oversight activities to ensure adequate quality presence in operational areas and effective execution of on‑the‑floor oversight responsibilities, including process monitoring, batch record review, area audits, and quality event identification.
• Establish performance expectations, objectives, training plans, and development opportunities for direct reports to ensure consistent execution of oversight activities and continued professional growth.
• Provide coaching, mentoring, and technical guidance to Compliance & Oversight personnel regarding GMP requirements, procedural expectations, quality risk identification, and decision‑making.
• Offer real‑time quality support and problem‑solving assistance for operational and quality‑related events, assess impact, determine appropriate escalation, and facilitate timely resolution.
• Ensure timely identification, communication, documentation, and escalation of quality events, procedural deviations, compliance risks, and operational concerns.
• Monitor the quality and effectiveness of on‑the‑floor oversight activities, including batch record review, area audits, process observations, and execution of oversight programs.
• Evaluate compliance trends, recurring observations, and operational risks identified through oversight activities; communicate emerging risks and drive implementation of corrective actions and improvements.
• Maintain appropriate staffing levels and manage performance of direct reports through recruitment, onboarding, performance management, employee development, coaching, and recognition activities.
• Partner with Manufacturing, Packaging, Warehouse, Engineering, Validation, QC, and other departments to promote compliance, resolve issues, and support successful execution of site operations.
• Support regulatory inspections, client audits, internal audits, and corporate assessments by ensuring personnel inspection readiness and providing subject‑matter expertise regarding QA Oversight activities.
• Ensure Compliance & Oversight personnel maintain a thorough understanding of applicable regulations, site procedures, quality standards, and current industry expectations.
• Lead and participate in cross‑functional teams to address complex quality issues, improve operational compliance, and support site quality objectives.
• Develop, monitor, and communicate departmental metrics related to oversight activities, compliance performance, inspection readiness, audit observations, resource utilization, and continuous improvement initiatives.
• Identify opportunities to strengthen quality oversight programs, improve operational compliance, enhance efficiency, and promote a culture of quality, accountability, and continuous improvement.

Qualifications

• Bachelor of Arts or Science required; Associates degree considered with 7 years directly related experience.
• Minimum 4 years of experience; supervisory and lead experience required.
• Pharmaceutical and FDA‑regulated industry experience required.
• Expert knowledge of cGMP regulations, GDP requirements, and pharmaceutical manufacturing operations.
• Demonstrated ability to provide and lead independent QA oversight of manufacturing operations during process execution, including real‑time quality and compliance decision‑making.
• Experience overseeing on‑the‑floor batch record review, process monitoring, area audits, and quality risk identification.
• Strong problem‑solving skills with ability to assess quality events, determine product and compliance impact, and drive appropriate escalation and resolution.
• Ability to identify compliance trends, evaluate operational risks, and implement corrective actions and continuous improvement initiatives.
• Experience leading, coaching, and developing QA Oversight personnel while promoting a culture of quality, accountability, and inspection readiness.
• Effective communication across all organizational levels and ability to influence decisions in support of quality and compliance objectives.
• Analytical skills to evaluate risk and make timely, well‑reasoned decisions in dynamic operational environments.
• Proactive issue identification, conflict resolution, and sustainable solution implementation.
• Ability to build productive working relationships and partner effectively with cross‑functional teams.
• Flexibility in changing priorities while promoting innovation, efficiency, and continuous improvement.
• Consistent demonstration of sound judgment, professionalism, and commitment to patient safety, product quality, and regulatory compliance.
• Vision Requirements: 14/14 Corrected Near‑Point, Pass Color Deficiency Test.
• Physical Requirements: Prolonged sitting required.

Benefits

• Medical, Dental, and Vision coverage starting on day one.
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA).
• Life & AD&D insurance.
• Short‑Term & Long‑Term Disability insurance.
• Employee Assistance Program.

Pay

Salary range: $84,975 – $99,963 annually, with opportunities for growth, promotion, and annual raises.

Location

Spokane, WA — On‑site, Full‑time.