SOP Project Manager

We are seeking an experienced SOP Project Manager to support a biotech company’s Quality Assurance (QA) organization with SOP development, policy and procedure management, and inspection readiness activities.

• Project-manage the QA SOP, policy, and procedure development queue from initiation through review and completion.
• Coordinate and schedule meetings with cross-functional stakeholders and subject matter experts.
• Track document comments, action items, timelines, and approvals to keep projects moving forward.
• Stage and prepare documents for review by appropriate stakeholders.
• Work collaboratively with stakeholders and subject matter experts to resolve document comments and ensure alignment.
• Convert and reformat source materials, including bullet points and informal content, into complete, professionally structured SOPs and related controlled documents.
• Ensure documents are formatted consistently with established SOP/document format and standards.
• Support QA with document organization, workflow coordination, and other activities that contribute to inspection readiness.
• Identify potential delays or issues within the SOP development process and proactively drive resolution.
• Maintain clear project tracking and communication across multiple concurrent SOP and policy initiatives.

• Demonstrated GCP experience within a clinical research, biotech, pharmaceutical, or related environment.
• SOP, policy, or procedural writing experience, preferably as a medical writer, technical writer, quality documentation specialist, or in a comparable role.
• Strong project management and organizational skills, with the ability to manage multiple documents and stakeholders simultaneously.
• Experience coordinating document reviews, consolidating comments, and driving documents through review and approval workflows.
• Strong written and verbal communication skills.
• Ability to take relatively high-level or unstructured source material and transform it into clear, complete, professional SOPs.
• Strong attention to detail and ability to work independently in a remote environment.