Operations Manager – Global External Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee daily operations at one or more Contract Manufacturing Organizations (CMOs).

• Implement production strategies with CMOs to ensure a continuous supply of clinical and commercial products.

• Coordinate meeting schedules with CMOs and cross-functional team members.

• Identify supply chain limitations and negotiate solutions with CMOs.

• Manage operational escalations and communications within the process team and GEO site.

• Collaborate with cross-functional teams to guarantee a steady product supply.

• Conduct root cause analysis and execute corrective actions.

• Oversee material movement between CMO facilities in collaboration with internal partners.

• Visit CMO locations to observe production activities and enhance understanding of manufacturing processes and systems.

• Maintain visual metrics and dashboards to monitor GEO business performance.

• Facilitate assessments of process modifications, change requests, and deviations.

• Ensure effective communication between CMOs, BioMarin manufacturing, and other departments.

• Lead or engage in technology transfers, product launches, and validation initiatives.

• Assist in developing formal systems and procedures for selecting CMOs.

• Implement control systems while adhering to budget constraints and minimizing costs of goods.

• Verify CMO compliance with cGMPs in collaboration with Corporate Compliance and Quality departments.

• Support CMO contracts and negotiations alongside procurement and EPM teams.

• Represent designated products, CMOs, and GEO Operations in pertinent meetings.

• Establish GEO processes and project templates for Operational Readiness Planning (ORP) management as necessary.

• Conduct operational gap analyses for new CMOs and spearhead mitigation plans.

• Ensure the seamless transition of operations from PPQ/launch to commercial process teams.

• Lead site exit initiatives as required.

⛳️ Requirements

• A minimum of 5 years of leadership experience in Operations, Supply Chain, or Quality.

• Bachelor’s degree in life sciences, business, or supply chain management.

• Strong understanding of processes and unit operations.

• Proven ability to lead and manage cross-functional, multidisciplinary teams.

• Capable of guiding and supporting cross-functional teams in addressing immediate challenges while achieving long-term performance goals.

• Demonstrated effective decision-making skills.

• High levels of initiative, influence, coaching, and organizational capabilities.

• Experience in managing operations within a regulated GXP environment.

• Strong experience in stakeholder and relationship management.

• Familiarity with CAPA, FMEA, and RCA tools in a highly regulated manufacturing context is preferred.

• Exceptional organizational, written, verbal communication skills, and commercial acumen.

• Experience in supply planning or inventory management is advantageous.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Retirement savings plan with company matching.

• Opportunities for professional development and career advancement.

• Flexible work arrangements to promote work-life balance.