Senior GCP Process & Procedures Lead — Global Life Sciences

BIP US; New Jersey; Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Remote/hybrid work environment support

401k matching

PTO 20 days

Discretionary bonus

Employee assistance program

Job summary

BIP US is seeking a seasoned Process & Procedures Lead to strengthen procedural frameworks for a global Life Sciences client. You will translate complex processes into clear SOPs/WIs, engage SMEs and leaders across functions, and drive compliance, efficiency, and inspection readiness.

This high-impact role requires 5–10 years in pharma, strong writing and project management skills, and the ability to lead cross-functional initiatives in a dynamic global environment.

Qualifications

• 5–10 years in an external client-facing Consultant role or equivalent.
• 5–10 years documenting and updating business processes and procedures (SOPs/WIs) in Global Pharma/Biotech.
• Experience with a Document Management system, ideally Veeva.
• Knowledge of GCP regulations and compliance requirements.
• Industry experience in Global Pharma/Biotech.
• Ability to discuss complex information with diverse stakeholders.
• Experience in controlled procedural document principles and process improvements.
• Ability to translate complex processes into lean, clear processes.
• Strong leadership, organizational and project management skills.
• Bachelor’s degree; MBA or advanced degree preferred.

Responsibilities

• Lead cross-functional conversations with SMEs and business leaders globally to design and optimize SOPs/WIs.
• Assess impact of procedural updates on existing processes and ensure alignment with compliance.
• Identify stakeholders for content development, reviews, and approvals; manage timelines.
• Map processes with scope, boundaries, inputs, outputs, steps, sequences, and visuals.
• Author clear, compliant procedural documentation per internal standards.
• Maintain project schedules, identify risks, and escalate with mitigation plans.
• Address procedural gaps related to deviations, CAPAs, and inspection readiness.
• Collaborate with Quality Managers to align content with Lean Writing Principles.
• Coordinate document workflows and approvals within DMS and with business stakeholders.

Skills

Client-facing experience

Process documentation

Project leadership

GCP knowledge

Document management (Veeva)

Pharma/Biotech domain

Cross-functional collaboration

Bachelor's degree

MBA preferred

Education

Bachelor's degree in engineering or business

MBA or advanced degree preferred

Tools

Veeva

Job description

BIP US is seeking a seasoned Process & Procedures Lead to strengthen procedural frameworks for a global Life Sciences client. You will translate complex processes into clear SOPs/WIs, engage SMEs and leaders across functions, and drive compliance, efficiency, and inspection readiness.

This high-impact role requires 5–10 years in pharma, strong writing and project management skills, and the ability to lead cross-functional initiatives in a dynamic global environment.