Operations Manager – Global External Operations

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: