Remote Life Sciences SOPs & Process Lead

BIP US; New York (NY); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Disability insurance

HSA and FSAs

401k matching

Paid parental leave

PTO 20 days

Sick days 7

Remote/hybrid work environment support

Job summary

BIP US Consulting is seeking a seasoned Process & Procedures Lead to support a global Life Sciences client, strengthening its procedural framework amid rapid international growth and evolving regulatory demands. You will design, map, and author SOPs/WIs, translating complex processes into compliant documentation for operational efficiency and inspection readiness.

You will lead cross-functional discussions, engage SMEs and business leaders, manage document workflows, and ensure timely delivery

Qualifications

• Minimum 5-10 years in an external client facing role as a Consultant or other relevant experience.
• 5-10 years of experience documenting and updating business processes and procedures, with a focus on authoring SOPs and WIs in Global Pharma/Biotech.
• Document Management system experience, ideally in Veeva.
• Knowledge of GCP regulations and compliance requirements.
• Industry or consulting experience in Global Pharma/Biotech.
• Ability to discuss complex information with diverse stakeholders.
• Experience in controlled procedural documents, process design and improvements.
• Ability to translate complex processes into lean processes.
• Strong leadership, organizational, and project management skills.
• Bachelor’s degree in engineering, business, or related field; MBA preferred.

Responsibilities

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

Skills

Leadership

Project management

Process design

Lean writing

Documentation

Veeva

GCP knowledge

Stakeholder management

Education

Bachelor’s degree in engineering or business

MBA or advanced degree preferred

Tools

Veeva

Document Management System

Job description

BIP US Consulting is seeking a seasoned Process & Procedures Lead to support a global Life Sciences client, strengthening its procedural framework amid rapid international growth and evolving regulatory demands. You will design, map, and author SOPs/WIs, translating complex processes into compliant documentation for operational efficiency and inspection readiness.

You will lead cross-functional discussions, engage SMEs and business leaders, manage document workflows, and ensure timely delivery