Life Sciences Process & Procedures Lead — Remote

BIP US; New York (NY); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Disability Insurance

HSA and FSAs

401k Match

Bonus Potential

Referral Bonus

Paid Parental Leave

Job summary

BIP US is seeking a seasoned Process & Procedures Lead to strengthen procedural documentation for a Global Life Sciences client. You will collaborate with SMEs and business leaders across global functions to design, map, and author SOPs and WIs, ensuring compliance and inspection readiness.

You will translate complex processes into concise procedural content, manage timelines, and drive cross-functional alignment to meet regulatory expectations and client objectives.

Qualifications

• 5–10 years in an external client-facing consulting role
• 5–10 years documenting and updating business processes and procedures in Global Pharma/Biotech
• Experience with Document Management systems, ideally Veeva
• Knowledge of GCP regulations and compliance requirements
• Global Pharma/Biotech industry experience preferred

Responsibilities

• Assess impact of procedural updates on existing processes
• Engage SMEs and business leaders for content development and approvals
• Lead process mapping sessions and capture scope, inputs, outputs, steps
• Facilitate discussions to align scope and drive consensus on updates
• Translate cross-functional activities into procedural documentation and maps
• Author procedural documents to internal content standards
• Maintain project schedules and escalate risks with recommendations
• Address procedural gaps related to deviations, inspections, and CAPAs
• Collaborate with Quality Managers to ensure content aligns with standards
• Manage document workflows and coordinate approvals with stakeholders

Skills

Stakeholder engagement

Process mapping

Lean writing

Leadership

Project management

Education

Bachelor’s degree in engineering or business

MBA/equivalent advanced degree preferred

Tools

Veeva

Job description

BIP US is seeking a seasoned Process & Procedures Lead to strengthen procedural documentation for a Global Life Sciences client. You will collaborate with SMEs and business leaders across global functions to design, map, and author SOPs and WIs, ensuring compliance and inspection readiness.

You will translate complex processes into concise procedural content, manage timelines, and drive cross-functional alignment to meet regulatory expectations and client objectives.