Manager - Mfg Compliance & Ops

Job Description

The Manufacturing, Manufacturing Compliance & Operations is responsible for ensuring robust GMP compliance across ABU manufacturing operations while actively supporting production teams to improve efficiency, effectiveness, and overall manufacturing performance. This role moves beyond traditional compliance oversight by serving as a strategic partner to Manufacturing Supervisors and Managers, providing real-time operational support, identifying process improvement opportunities, and driving solutions that enhance both compliance and productivity.

Manufacturing Support & Operational Partnership

• Act as a primary compliance and operations partner to Manufacturing Supervisors and Managers
• Provide floor-level support and real-time guidance during manufacturing operations
• Proactively identify and resolve issues that impact throughput, right-first-time execution, and schedule adherence
• Support execution of batches by assisting with decision-making, troubleshooting, and escalation
• Ensure compliance expectations are met while enabling practical, efficient execution of manufacturing activities

Compliance Oversight & Execution

• Own and oversee deviations, CAPAs, change controls, training compliance, and documentation for manufacturing
• Ensure all records and quality events are timely, accurate, and inspection-ready
• Perform and lead deviation investigations, including root cause analysis and effectiveness checks
• Drive closure of quality records with a focus on sustainable, operation-friendly solutions
• Maintain proficiency in TrackWise systems for deviations, CAPA, and change control

Process Improvement & Manufacturing Efficiency

• Identify, lead, and support continuous improvement initiatives across manufacturing
• Analyze trends in deviations, batch performance, and operational inefficiencies to implement proactive improvements
• Partner with Manufacturing, QA, MSAT, and support groups to simplify processes, eliminate waste, and improve cycle times
• Drive improvements in Right First Time (RFT), deviation reduction, and batch release timelines
• Translate compliance requirements into practical, streamlined manufacturing processes

Documentation & Training Leadership

• Oversee generation, review, and optimization of SOPs, batch records, and associated manufacturing documents
• Ensure documentation supports both compliance and operational efficiency
• Provide and coordinate cGMP, job task, and operational training for manufacturing personnel
• Coach staff on best practices for documentation, execution, and compliance behaviors

Leadership & Team Development

• Provide leadership, coaching, and performance management for assigned personnel
• Develop team capabilities beyond transactional compliance to include problem-solving and operational awareness
• Partner with management to establish performance expectations aligned with safety, quality, and productivity goals
• Support hiring, onboarding, and development of manufacturing and support staff

Cross-Functional Collaboration

• Work closely with Quality Assurance, Maintenance, Engineering, MSAT, and other support functions
• Ensure issues are addressed with balanced consideration of compliance, risk, and operational impact
• Drive alignment between departments to improve end-to-end manufacturing performance
• Participate in cross-functional forums to address systemic challenges and improvement opportunities

Performance Monitoring & Reporting

• Support development and reporting of manufacturing performance metrics (e.g., deviations, RFT, cycle time, CAPA effectiveness)
• Analyze data to identify trends and recommend actionable improvements
• Contribute to production monitoring, cost awareness, and resource optimization efforts

Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, Manufacturing or related field required
• Bachelor's degree preferred or 5+ years industry/related experience in lieu of degree
• Manufacturing leadership 3+ years required
• Demonstrated experience in both: GMP compliance systems (deviations, CAPA, change control) AND Direct manufacturing support or operations
• LSS Certification desired
• Pharma Manufacturing or related Supervisory/Management experience desired
• Microsoft Word and Excel required, PowerPoint desired
• Strong knowledge of cGMP regulations (21 CFR Part 210/211) required
• Proficiency in quality systems (TrackWise or equivalent) required
• Data analysis and problem-solving in a manufacturing environment required
• Ability to translate compliance requirements into practical execution required
• Ability to influence without authority across functions required
• Strong decision-making in real-time operational settings required
• Effective communication with both shop floor and leadership required
• Continuous improvement mindset with bias toward action required

Other Physical Requirements

• Exposure to allergens
• Working in aseptic areas
• Prolonged sitting and standing

Location

Spokane, WA — Full-Time Onsite

Shift

Monday-Friday | 7:00AM-4:00PM

Compensation & Benefits

Hiring Wage: $102,100.00– $163,300.00, 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

Our Promise

Caring, Sharing, Growing

We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society.