Mgr - Mfg Compliance & Op

Overview

Jubilant Hollister Stier LLC, Spokane’s largest manufacturing company, offers a full range of pharmaceutical and biopharmaceutical manufacturing services, supporting life‑changing medicines worldwide. The company is nationally recognized for producing sterile injectable vials and lyophilized products, and its allergy business leads the market in allergenic extracts.

• 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.
• A career you can grow:
  Opportunities for growth, promotion, and annual raises, with compensation reserved for high performance.
• A culture of improvement:
  We value continuous improvement, innovation, and hands‑on contribution.
• A stable industry leader:
  Supported by Jubilant Pharma, we combine stability with forward‑looking innovation.

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.

• 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 batch execution 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.
  • 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 Track Wise 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, 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…