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 operationsduring process execution.
- Manage daily oversight activities to ensure adequate quality presence in operational areas andeffective execution of on-the-floor oversight responsibilities, including process monitoring, batchrecord review, area audits, and quality event identification.
- Establish performance expectations, objectives, training plans, and development opportunitiesfor direct reports to ensure consistent execution of oversight activities and continued professionalgrowth.
- Provide coaching, mentoring, and technical guidance to Compliance & Oversight personnelregarding 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 batchrecord review, area audits, process observations, and execution of oversight programs.
- Evaluate compliance trends, recurring observations, and operational risks identified throughoversight activities. Communicate emerging risks and drive implementation of appropriatecorrective actions and improvements.
- Maintain appropriate staffing levels and manage the performance of direct reports throughrecruitment, onboarding, performance management, employee development, coaching, andrecognition activities.
- Partner with Manufacturing, Packaging, Warehouse, Engineering, Validation, QC, and otherdepartments to promote compliance, resolve issues, and support successful execution of siteoperations.
- Support regulatory inspections, client audits, internal audits, and corporate assessments byensuring personnel inspection readiness and providing subject matter expertise regarding QAOversight activities.
- Ensure Compliance & Oversight personnel maintain a thorough understanding of applicableregulations, site procedures, quality standards, and current industry expectations.
- Lead and participate in cross-functional teams to address complex quality issues, improveoperational 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- -TimeShift: Monday-Wednesday E/O Thursday | 6:00AM-6:00PM
Compensation & Benefits That Start on Day One - Because Your Well Being Matters Hiring Wage: $83,300-$119,000 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 PotentialIf you're seeking a dynamic and rewarding career, we welcome your application today. Apply online:
Careers - Jubilant HollisterStier
