Process Improvement Manager

MSI Pharma; United States; On-site; USD 80,000 - 120,000; Full time

Job summary

A leading global biotechnology company seeks a Process Improvement Manager to provide ongoing support to Clinical Development Operations. This role focuses on coordinating SOP management, ensuring process compliance, and driving continuous improvements in a regulated clinical environment. Ideal candidates will have experience in process management and a background in the biotech or pharmaceutical sectors. Strong communication and stakeholder coordination skills are essential. This is a contract position based in the United States.

Qualifications

• Proven experience in process management and continuous improvement.
• Familiar with coordination of SOPs and regulatory documentation.
• Experience within regulated pharmaceutical or biotech sectors is essential.

Responsibilities

• Maintain Clinical Development SOPs and documentation.
• Coordinate updates for process changes and regulatory updates.
• Ensure compliance and control of processes and documentation.

Skills

Process management and continuous improvement experience

Coordination of SOPs and procedural documentation

Experience in regulated pharma or biotech environments

Understanding of how regulatory changes impact processes

Exposure to Clinical Development Operations

CRO interface and procedural alignment experience

Strong stakeholder coordination and communication skills

Highly detail-oriented and organized

Comfortable supporting BAU operations

Confident working across global, cross-functional teams

Education

Degree in life sciences or related discipline preferred

Equivalent industry experience

Job description

Location: America Engagement Status: Contract (Ongoing)

We are partnered with a leading global biotechnology company who is looking for a Process Improvement Manager to provide BAU support to the Clinical Development Operations. This role focuses on process coordination, SOP management, and continuous improvement within a regulated clinical development environment.

Key Responsibilities

• Own and maintain Clinical Development SOPs and procedural documentation
• Coordinate documentation updates following process changes, CRO procedural updates, and new or updated regulations
• Ensure processes and documentation are controlled, compliant, and inspection ready
• Identify and support practical process improvements with process owners
• Coordinate training activities linked to procedure changes (not training design)
• Act as a key contact for CROs to ensure procedural and process alignment
• Support inspection and audit readiness activities with Quality and Clinical Ops

Requirements

Hard Skills

• Process management and continuous improvement experience
• Coordination of SOPs and procedural documentation
• Experience in regulated pharma or biotech environments
• Understanding of how regulatory changes impact processes
• Exposure to Clinical Development Operations
• CRO interface and procedural alignment experienceInspection/audit readiness exposure
• Quality or Quality System exposure

Soft Skills

• Strong stakeholder coordination and communication skills
• Highly detail‑oriented and organized
• Comfortable supporting BAU operations
• Practical, hands‑on approach
• Confident working across global, cross‑functional teams

Education

• Degree in life sciences or related discipline preferred
• Equivalent industry experience considered

This role is not clinical trial delivery, learning design, or large‑scale transformation.