Lead QA Compliance & Oversight - Onsite Spokane

Jubilant Pharma Limited; Spokane (WA, MO); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Medical, Dental & Vision

FSA/HSA

Life & AD&D Insurance

Disability Insurance

Employee Assistance Program

Job summary

Jubilant HollisterStier LLC in Spokane, WA seeks a Supervisor QA Compliance and Oversight to lead real-time QA oversight across manufacturing, packaging, warehouse, and labs. You will coach staff, establish training plans, monitor processes, and drive quality risk management to ensure compliant operations.

Qualifications include a BA/BS (or AA/AS with 7+ years related experience), 4+ years in supervisory roles, and strong GMP/regulatory knowledge. Competitive wages and day-one benefits offered.

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.

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 resolutionof 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.

Skills

QA Oversight

GMP Knowledge

Process Monitoring

Area Audits

Training & Development

Regulatory Compliance

Problem Solving

Cross-functional Collaboration

Documentation & Reporting

Quality Event Management

Education

Bachelor of Arts or Science

Associates of Arts or Science (in lieu of Bachelor’s)

Job description

Jubilant HollisterStier LLC in Spokane, WA seeks a Supervisor QA Compliance and Oversight to lead real-time QA oversight across manufacturing, packaging, warehouse, and labs. You will coach staff, establish training plans, monitor processes, and drive quality risk management to ensure compliant operations.

Qualifications include a BA/BS (or AA/AS with 7+ years related experience), 4+ years in supervisory roles, and strong GMP/regulatory knowledge. Competitive wages and day-one benefits offered.