Operations Manager – Global External Operations

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Job Description:

  • Manage day-to-day activities at one or more Contract Manufacturing Organizations (CMOs)
  • Execute production plans with CMOs to deliver uninterrupted clinical and commercial product supply
  • Manage CMO meeting schedules with cross-functional colleagues
  • Identify supply constraints and negotiate or resolve issues with CMOs
  • Manage operational escalations and communications within the process team/GEO site
  • Collaborate with cross-functional teams to ensure uninterrupted product supply
  • Perform root cause analysis and implement corrective actions
  • Manage material movement between CMO sites with internal partners
  • Attend CMO sites to monitor production campaigns and develop knowledge of manufacturing processes and systems
  • Maintain visual metrics/dashboards overseeing GEO business
  • Coordinate evaluations of process changes, change requests, and deviations
  • Facilitate communications between CMOs, BioMarin manufacturing, and other departments
  • Lead or participate in technology transfers, product launches, and validation activities
  • Contribute to formal systems and procedures for CMO selection
  • Implement control systems within budget and reduce cost of goods
  • Ensure CMO compliance with cGMPs with Corporate Compliance and Quality departments
  • Support CMO contracts and negotiations with procurement and EPM teams
  • Represent assigned products, CMOs, and GEO Operations at relevant meetings
  • Establish GEO processes and project templates for ORP management as required
  • Conduct operational gap analyses for new CMOs and lead mitigation plans
  • Ensure transition of operations from PPQ/launch into commercial process teams
  • Lead site exit projects as required

Requirements:

  • Minimum requirement of 5 years leadership experience in Operations, Supply Chain or Quality
  • BS/BA degree in life sciences, business, or supply chain management
  • Excellent understanding of processes/unit operations
  • Demonstrated ability to lead/manage cross-functional, multi-disciplinary teams
  • Ability to guide and support cross-functional teams in resolving short-term issues and achieving sustained long-term performance
  • Proven effective decision-making ability
  • High initiative, influencing, coaching, and organizational skills
  • Experience working and managing in a regulated GXP environment
  • Strong stakeholder and relationship management experience
  • Experience with CAPA, FMEA, and RCA tools in a highly regulated manufacturing environment desired
  • Excellent organizational, written, verbal communication, and commercial acumen
  • Experience in supply planning or inventory management

Benefits:

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