Sr Project Manager, Global External Manufacturing
BioMarin Pharmaceutical Inc.
4 hours ago
Remote friendly (San Rafael, CA)
United States
Operations
Role Purpose
The Senior Project Manager drives disciplined, end-to-end project delivery across the GEO site portfolio and the global external manufacturing network, ensuring projects are planned, governed, and executed against approved scope, cost, and schedule in a highly regulated environment.
Key Accountabilities
Project & Portfolio Management
- Manage assigned projects through the full lifecycle, from intake and approval through execution, handover, and benefits realization.
- Establish and maintain project charters, RAID logs, decision logs, and governance artifacts for transparent, consistent, audit-ready oversight.
- Ensure project scope, prioritization, and objectives align with strategic, operational, compliance, and capacity requirements across GEO.
- Prepare and present concise, decision-focused project reviews for governance forums.
- Lead/support continuous improvement by identifying recurring execution pain points, inefficiencies, and failure modes; partner with stakeholders to improve processes and governance.
Project Planning & Schedule Ownership
- Independently build, maintain, and optimize integrated project schedules using digital project management tools (e.g., MS Project or equivalent), including logic ties, milestones, dependencies, and critical paths.
- Translate technical, quality, validation, and manufacturing inputs into execution-ready timelines (with SMEs).
- Analyze schedule health to identify slippage drivers, downstream impacts, compression opportunities, and mitigation strategies.
- Use schedule data to proactively surface risks, tradeoffs, and decision points.
External Manufacturing (CMO) Project Delivery
- Serve as the structured project interface with CMOs to align deliverables, timelines, resource needs, and approval pathways.
- Integrate CMO activities into end-to-end project schedules and manage external dependencies.
- Support technical transfer, validation, quality, engineering, and supply continuity initiatives.
- Ensure documentation, change control, and execution activities meet GMP expectations and are inspection-ready.
Integration & Decision Support
- Consolidate schedule, risk, and capacity data across projects to surface decision needs and escalation items.
- Explain what is happening and why (root causes, leading indicators, implications for scope/schedule/resources).
- Maintain decision logs and ensure actions, owners, and due dates are tracked and closed.
Resource, Risk & Dependency Management
- Balance resource demands with operational constraints; surface capacity conflicts and dependency risks for timely escalation.
- Maintain integrated views of critical paths, interdependencies, and mitigation actions across internal teams and CMOs.
- Enforce risk management and change control to protect approved scope, schedule, and compliance commitments.
Stakeholder Engagement & Digital
- Drive cross-functional alignment by setting clear expectations, resolving execution issues, and escalating delivery-threatening risks.
- Deliver concise, decision-focused project updates to the Head of Strategy and Business Operations and senior stakeholders.
- Support consistent application of governance forums, standards, and ways of working.
- Enable digital/data-enabled ways of working using PMO standards, dashboards, and analytics.
Qualifications
Education
- Bachelor’s degree in Engineering/Science, Business, or Information Systems (or equivalent experience).
- PMP certification preferred.
- Lean Six Sigma Green Belt or higher preferred.
Experience
- Minimum 5 years’ experience in project management or business process improvement within a GMP-regulated manufacturing environment.
- Proven experience independently building and managing complex project schedules with cross-functional and external dependencies.
- Experience delivering or supporting technical transfers, validations, engineering changes, or portfolio projects.
- Experience in external/contract manufacturing is an advantage.
Skills & Competencies
- Exceptional communication skills; tailor messages for technical teams, operational leaders, and senior executives while maintaining clarity.
- Strong organizational awareness; understands decision-making dynamics and works effectively in matrix environments.
- Ability to influence and mobilize cross-functional teams without direct authority.
- Skilled in conflict management and facilitating difficult conversations.
- Understanding of biopharma operations and compliance requirements.
- Financial/business acumen with disciplined governance oversight.
- Advanced digital literacy using modern project management, analytics, and AI-enabled tools to build/maintain integrated schedules, analyze risk, and produce decision-ready insights (e.g., MS Project, Power BI, or equivalent).
Workstyle & Travel
- Hybrid working model; travel to external partners as required (10–20%).
The Senior Project Manager drives disciplined, end-to-end project delivery across the GEO site portfolio and the global external manufacturing network, ensuring projects are planned, governed, and executed against approved scope, cost, and schedule in a highly regulated environment.
Key Accountabilities
Project & Portfolio Management
- Manage assigned projects through the full lifecycle, from intake and approval through execution, handover, and benefits realization.
- Establish and maintain project charters, RAID logs, decision logs, and governance artifacts for transparent, consistent, audit-ready oversight.
- Ensure project scope, prioritization, and objectives align with strategic, operational, compliance, and capacity requirements across GEO.
- Prepare and present concise, decision-focused project reviews for governance forums.
- Lead/support continuous improvement by identifying recurring execution pain points, inefficiencies, and failure modes; partner with stakeholders to improve processes and governance.
Project Planning & Schedule Ownership
- Independently build, maintain, and optimize integrated project schedules using digital project management tools (e.g., MS Project or equivalent), including logic ties, milestones, dependencies, and critical paths.
- Translate technical, quality, validation, and manufacturing inputs into execution-ready timelines (with SMEs).
- Analyze schedule health to identify slippage drivers, downstream impacts, compression opportunities, and mitigation strategies.
- Use schedule data to proactively surface risks, tradeoffs, and decision points.
External Manufacturing (CMO) Project Delivery
- Serve as the structured project interface with CMOs to align deliverables, timelines, resource needs, and approval pathways.
- Integrate CMO activities into end-to-end project schedules and manage external dependencies.
- Support technical transfer, validation, quality, engineering, and supply continuity initiatives.
- Ensure documentation, change control, and execution activities meet GMP expectations and are inspection-ready.
Integration & Decision Support
- Consolidate schedule, risk, and capacity data across projects to surface decision needs and escalation items.
- Explain what is happening and why (root causes, leading indicators, implications for scope/schedule/resources).
- Maintain decision logs and ensure actions, owners, and due dates are tracked and closed.
Resource, Risk & Dependency Management
- Balance resource demands with operational constraints; surface capacity conflicts and dependency risks for timely escalation.
- Maintain integrated views of critical paths, interdependencies, and mitigation actions across internal teams and CMOs.
- Enforce risk management and change control to protect approved scope, schedule, and compliance commitments.
Stakeholder Engagement & Digital
- Drive cross-functional alignment by setting clear expectations, resolving execution issues, and escalating delivery-threatening risks.
- Deliver concise, decision-focused project updates to the Head of Strategy and Business Operations and senior stakeholders.
- Support consistent application of governance forums, standards, and ways of working.
- Enable digital/data-enabled ways of working using PMO standards, dashboards, and analytics.
Qualifications
Education
- Bachelor’s degree in Engineering/Science, Business, or Information Systems (or equivalent experience).
- PMP certification preferred.
- Lean Six Sigma Green Belt or higher preferred.
Experience
- Minimum 5 years’ experience in project management or business process improvement within a GMP-regulated manufacturing environment.
- Proven experience independently building and managing complex project schedules with cross-functional and external dependencies.
- Experience delivering or supporting technical transfers, validations, engineering changes, or portfolio projects.
- Experience in external/contract manufacturing is an advantage.
Skills & Competencies
- Exceptional communication skills; tailor messages for technical teams, operational leaders, and senior executives while maintaining clarity.
- Strong organizational awareness; understands decision-making dynamics and works effectively in matrix environments.
- Ability to influence and mobilize cross-functional teams without direct authority.
- Skilled in conflict management and facilitating difficult conversations.
- Understanding of biopharma operations and compliance requirements.
- Financial/business acumen with disciplined governance oversight.
- Advanced digital literacy using modern project management, analytics, and AI-enabled tools to build/maintain integrated schedules, analyze risk, and produce decision-ready insights (e.g., MS Project, Power BI, or equivalent).
Workstyle & Travel
- Hybrid working model; travel to external partners as required (10–20%).