Mgr - Mfg Compliance & Op

Overview Jubilant HollisterStier Spokane is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click here. If you’d like more information on your EEO rights under the law, please click here. Job Description Join a Leader in Pharmaceutical Manufacturing — And 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 lifechanging medicines around the world. 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. For the Builders, Innovators, and Doers — This Is Your Place If you are someone who thrives on solving complex problems, improving systems, and building real solutions , you’ll feel at home here. At Jubilant HollisterStier, your ideas matter — and your impact is felt globally. Why builders choose us: Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide. Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well-being shouldn’t have a waiting period. A career you can grow: We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity. A culture of improvement: We value people who thrive on continuous improvement, innovation, and hands on contribution. A stable industry leader: Backed by Jubilant Pharma, we pair long term stability with forward looking innovation. If you want to build something meaningful with a team that values your drive, skills, and ideas — you belong here. Job Description: The Manufacturing, Manufacturing Compliance & Operations role 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. The position integrates compliance activities (deviations, CAPA, change control, and documentation) with proactive manufacturing support to enable safe, reliable, and efficient production. A. 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 B. Compliance Oversight & Execution Own and oversee deviations, CAPAs, change controls, training compliance, and documentation 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 C. 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 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 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 F. 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 G. 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 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 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 Interpretation of cGMP regulations. Subject to practices/well defined policy, management reviews results after the fact. Provides analysis, diagnosis or production tasks which noticeably impact end results Location: Spokane, WA — Full-Time Onsite Shift: Monday-Friday |7:00AM-4:00PM Compensation & Benefits That Start on Day One — Because Your Well Being Matters 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: Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA) Life & AD&D Insurance Short-Term & Long-Term Disability Insurance Employee Assistance Program EEO notice Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If you require assistance applying for a position, contact: View email address on click.appcast.io 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. COMPANY : Jubilant HollisterStier Spokane #J-18808-Ljbffr