Job Summary

Senior Program Manager – Cleaning Cross-contamination program

Function Purpose

The Senior Program Manager supports the Program Lead in the planning, coordination, and execution of a global Program on Cross-Contamination across Synthetics Drug Substance and Drug Product operations.

The role is responsible for bringing structure, visibility, and execution discipline to a complex, cross-functional and global program, translating program objectives and technical requirements into clear plans, deliverables, milestones, ownership, dependencies, risks, and implementation actions.

The ideal candidate combines strong program management capabilities with sufficient technical understanding of pharmaceutical manufacturing processes, preferably Cleaning Validation, to effectively connect technical discussions with program execution.

Key Responsibilities

• Program planning and governance: Establish and maintain the overall program structure, governance, roadmap, deliverables, milestones, decision points, and reporting mechanisms.
• Integrated planning: Develop and maintain an integrated program plan across workstreams, ensuring alignment of activities, timelines, dependencies, deliverables, and site deployment activities.
• Project and program scheduling: Set up, maintain, update, and report integrated schedules, including key milestones, dependencies, critical paths, priorities, and progress against plan.
• Cross-workstream coordination: Connect activities across technical, quality, compliance, data, training, communication, and site implementation workstreams, proactively identifying interdependencies and potential gaps.
• Global and site coordination: Ensure effective coordination and information flow between global teams and manufacturing sites, supporting consistent deployment of the defined approach while maintaining clear ownership of site implementation activities.
• Risk and issue management: Identify, document, and track program risks, issues, dependencies, decisions, and mitigation actions, ensuring timely escalation to the Program Lead and governance teams when required.
• Action and decision management: Maintain visibility of key actions, owners, due dates, decisions, and open points, and actively drive follow-up to support timely completion.
• Stakeholder management: Coordinate across a complex global matrix organization involving multiple functions, technical SMEs, manufacturing sites, and senior stakeholders, ensuring alignment on priorities, responsibilities, timelines, and expectations.
• Governance and leadership communication: Prepare concise, high-quality program updates, dashboards, governance materials, decision inputs, and executive-level communications.
• Change and deployment support: Coordinate communication, training, guidance, workshops, and other change-management activities required to support consistent adoption of the global approach.

• Program execution: Proactively identify barriers to execution and work with workstream leads and stakeholders to develop practical solutions, maintain momentum, and ensure delivery against program commitments.

Skill Requirements

• Strong senior-level program/project management experience in complex, global, cross-functional environments, preferably within pharmaceutical manufacturing, MSAT, Quality, Technical Operations, or Supply Chain.
• Demonstrated ability to manage programs with multiple parallel workstreams, global and site-level activities, complex dependencies, and senior stakeholder interfaces.
• Strong capability in developing and managing integrated program plans, milestones, critical paths, dependencies, actions, risks, issues, and decision logs.
• Ability to translate technical and business requirements into structured, actionable execution plans.
• Experience operating within a regulated pharmaceutical or life-sciences environment, with an understanding of GMP and Quality/Regulatory interfaces.
• Strong stakeholder management skills and demonstrated ability to influence and drive execution without direct authority in a global matrix organization.
• Ability to facilitate cross-functional discussions, clarify ownership and accountabilities, and drive teams toward decisions and closure.
• Strong communication skills, including preparation of executive-level updates, governance materials, dashboards, and decision documents.
• Ability to work effectively with technical SMEs while maintaining an overall program perspective and connecting technical decisions to implementation timelines and dependencies.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities in a fast-moving and evolving program.

Other Requirements

• Experience or working knowledge of Cleaning Validation in pharmaceutical manufacturing, including cleaning processes, validation lifecycle, risk assessment, and implementation within a GMP environment.
• Experience in contamination control, cross-contamination risk management, or related pharmaceutical manufacturing processes.
• Familiarity with risk management and implementation of new Quality/Regulatory requirements across manufacturing organizations would be an advantage.
• Experience supporting global deployment of new procedures, technical standards, guidance documents, or compliance requirements across multiple manufacturing sites.
• Experience working across Small Molecule Drug Substance and/or Drug Product manufacturing.
• Experience with program management and reporting tools such as Microsoft Project and other enterprise project/portfolio management platforms.

Prior experience working in a J&J FPX project environment is preferred