Job Description:

The Supervisor II, Compliance & Oversight is responsible for leading 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 through active oversight of manufacturing, packaging, warehouse, laboratory, and support operations, including on-the-floor batch record review, operational monitoring, area audits, and quality risk identification.

• 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.

• Provide real-time quality support and problem-solving assistance for operational and quality-

related events. Assess impact, determine appropriate escalation, and facilitate timely resolution

of issues.

• 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 appropriate

corrective actions and improvements.

• Maintain appropriate staffing levels and manage the 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. 15. 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, but will consider Associates of Arts or Science with a solid 7 years directly related experience in lieu of Bachelor's degree.
• 4 years' experience required. Supervisory and lead experience required. Pharmaceutical and FDA regulated industry experience required.
• Expert knowledge of cGMP regulations, GDP requirements, and pharmaceutical manufacturing operations required.
• Demonstrated ability to provide and lead independent QA oversight of manufacturing operations during process execution, including real-time quality and compliance decision making required.
• Experience overseeing on-the-floor batch record review, process monitoring, area audits, and quality risk identification required.
• Strong problem-solving skills with the ability to assess quality events, determine product and compliance impact, and drive appropriate escalation and resolution required.
• Ability to identify compliance trends, evaluate operational risks, and implement corrective actions and continuous improvement initiatives required.
• Experience leading, coaching, and developing QA Oversight personnel while promoting a culture of quality, accountability, and inspection readiness required.
• Effectively coaches, mentors, and develops personnel while fostering accountability, engagement, and high performance.
• Communicates clearly and professionally across all organizational levels and effectively influences decisions in support of quality and compliance objectives.
• Analyzes complex situations, evaluates risk, and makes timely, well-reasoned decisions in dynamic operational environments.
• Proactively identifies issues, facilitates resolution of conflicts, and drives sustainable solutions to quality and operational challenges.
• Builds productive working relationships and partners effectively with cross-functional teams to achieve site objectives.
• Demonstrates flexibility in changing priorities while promoting innovation, efficiency, and continuous improvement.
• Consistently demonstrates sound judgment, professionalism, and commitment to patient safety, product quality, and regulatory compliance.

Vision Requirements:

• 14/14 Corrected Near-Point
• Pass Color Deficiency Test

Other Physical Requirements:

• Prolonged sitting required.

Location: Spokane, WA - On Site, Full-Time

Compensation & Benefits That Start on Day One - Because Your Well Being Matters

Hiring Wage: $84,975-$99,963 annually, with opportunities for growth, promotion, and annual raises.

At Jubilant HollisterStier, we don't believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.

Starting on your first day, you receive:

• Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program

Unlock Your Potential

If you're seeking a dynamic and rewarding career, we welcome your application today. Apply online:

Careers - Jubilant HollisterStier