Location: Remote - Thousand Oaks, CA

Employment Type: Contingent Worker (Contract, W2)

Contract Length: 12 months (possible extension)

Compensation: $60 / $80 per hour (based on experience)

Summary of the Role

Join a big biopharma leader as a Process Documentation Management expert, delivering quality leadership on key internal process change initiatives. This role ensures clear quality requirements, timely completion, and compliance in all process documentation activities. Leverage your expertise to partner cross-functionally and steward strong documentation practices supporting organizational goals.

Key Responsibilities

• Set strategy for R&D controlled document management at the project or program level to enable R&D objectives
• Ensure compliance with the company's document hierarchy and standards for R&D
• Oversee and provide quality input for developing clinical trial processes and standards
• Adapt and implement technical and digital solutions to advance compliance and user adoption
• Lead and ensure controlled documents meet regulatory and company obligations, including content controls
• Partner with Quality functions for aligned advice on documentation practices and quality
• Identify, prioritize, and resolve gaps in the Quality Management System related to document management
• Support inspection readiness and planned deviation management as needed

Required Experience & Skills

• Significant experience in Quality Management, Document Management, Compliance, or related areas in the pharmaceutical/biotech industry
• Strong document and process management background
• Expertise in change management initiatives
• Experience with clinical trials and knowledge of ICH GCP standards

Preferred Qualifications

• Bachelor’s degree in an appropriate field or advanced degree
• Proven record in pharmaceutical or biotech Quality Management, Document Management, or Compliance
• Experience in document and process management systems
• Expertise in change management initiatives
• Clinical trial experience and/or knowledge of ICH GCP

Top 3 Must Have Skills

1. Quality Management, Document Management, or Compliance experience in pharma/biotech

2. Document and process management expertise

3. Change management capabilities

Day-to-Day Responsibilities

• Develop and implement strategies for document management for R&D projects and programs
• Collaborate with global process owners and Quality teams to develop compliant documentation
• Oversee controlled document development, standards adherence, and regulatory compliance
• Drive adoption of new technical solutions for documentation
• Identify and resolve documentation or compliance gaps

Basic Qualifications

• Doctorate degree and 2 years of R&D or Quality experience
• Master’s degree and 6 years of R&D or Quality experience
• Bachelor’s degree and 8 years of R&D or Quality experience
• Associate degree and 10 years of R&D or Quality experience
• High school diploma / GED and 12 years of R&D or Quality experience
• And 2 years of leadership experience leading teams, projects, programs or advising the allocation of resources

This posting is for Contingent Worker, not an FTE