Supervisor - QC & Oversight
Join a leader in pharmaceutical manufacturing and help build what’s next. As Spokane’s largest manufacturing company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support life-changing medicines worldwide. We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global Jubilant Pharma family.
About the role
This position leads Quality Assurance Oversight personnel who provide independent, real-time quality oversight of GMP operations throughout process execution. You will ensure 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.
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.
- 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.
- Identify opportunities to strengthen quality oversight programs, improve operational compliance, enhance efficiency, and promote a culture of quality, accountability, and continuous improvement.
Requirements
- Bachelor of Arts or Science required; Associates of Arts or Science with 7 years of directly related experience may be considered in lieu of a Bachelor’s degree.
- 4 years of 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.
- Experience overseeing on-the-floor batch record review, process monitoring, area audits, and quality risk identification.
- Strong problem-solving skills with the 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.
Skills
- 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.
Physical Requirements
- Vision: 14/14 Corrected Near-Point Pass Color Deficiency Test
- Prolonged sitting required
Pay
Hiring wage: $84,975–$99,963 annually, with opportunities for growth, promotion, and annual raises.
Benefits
Benefits start on day one and include:
- Medical, Dental, and Vision coverage
- Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA)
- Life and AD&D Insurance
- Short-Term and Long-Term Disability Insurance
- Employee Assistance Program
Location: Spokane, WA — On Site, Full-Time