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:
