Sr Mgr Quality Compliance

Advanced Bio-Logic Solutions Corp•Thousand Oaks, CA

11h•$60 - $80•Remote

About The Position

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.

Requirements

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
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
Quality Management, Document Management, or Compliance experience in pharma/biotech
Document and process management expertise
Change management capabilities

Nice To Haves

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

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
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