Quality Document Control Supervisor

Biovire • Brighton, MI

1d • Onsite

About The Position

Biovire is advancing toward commercialization with a focus on innovation, operational excellence, and scalable GMP manufacturing. We are seeking a Quality Document Control Supervisor to lead and strengthen the document control activities that support pharmaceutical drug product and medical device manufacturing across our site. This is a hands-on Quality Systems leadership role with responsibility for controlled documentation, batch record issuance, document lifecycle management, archival and retention, and the day-to-day workflow of the Quality Document Control function. The role offers an opportunity to strengthen critical quality systems and processes as Biovire continues building the capabilities needed for commercial manufacturing.

Requirements

• Associate degree or equivalent combination of education and relevant work experience.
• Minimum of 2 years of experience in the pharmaceutical industry or a similar regulated environment.
• Minimum of 2 years of experience working with a controlled document management system.
• Knowledge of cGMP, Good Documentation Practices, and applicable regulatory principles, including 21 CFR Parts 11, 210, 211 and 820 and relevant ICH guidance.
• Strong attention to detail and demonstrated ability to identify and correct documentation and formatting errors.
• Strong organizational skills with the ability to manage multiple priorities and deadlines in a fast-paced environment.
• Strong written and verbal communication and interpersonal skills.
• Ability to work independently, exercise sound judgment, and collaborate effectively across functions.
• Proficiency with Microsoft Office applications, particularly Microsoft Word, and experience working with Adobe Acrobat and PDF documents.
• Demonstrated integrity and commitment to high quality, ethical, and compliance standards.

Nice To Haves

• Experience with paper-based document control systems.
• Experience implementing or transitioning to an electronic Quality Management System (eQMS).
• Previous experience leading or coordinating document control activities, workflows, or teams.
• Experience supporting regulatory or customer inspections and audits.

Responsibilities

• Oversee the day-to-day Quality Document Control function, team workflow, priorities, and deliverables.
• Oversee and support the development and generation of Master Batch Records and process required batch record revisions.
• Manage the development, creation, revision, routing, and control of Standard Operating Procedures (SOPs), forms, protocols, and other controlled documents.
• Issue controlled execution copies of batch records for Manufacturing and maintain appropriate controls and tracking of the issuance process.
• Partner with Process Engineering and other functions to develop documentation supporting new products and processes.
• Maintain controlled-document issuance records, logs, master files, and associated documentation.
• Oversee the controlled-document periodic review program.
• Generate and manage change controls and drive required document changes through completion.
• Oversee archival and record-retention processes for controlled documentation.
• Provide document control support during regulatory, customer, and other audits.
• Generate QDC metrics for monthly reporting and management review.
• Maintain documentation quality standards and Good Documentation Practices across controlled records.
• Participate in project teams and cross-functional Quality initiatives.
• Identify opportunities to strengthen, standardize, and improve document control processes and workflow.
• Ensure activities are performed in accordance with applicable safety requirements, cGMPs, SOPs, and regulatory expectations.

Benefits

• Company-sponsored medical, dental, vision, and life insurance.
• Paid Time Off supporting work-life balance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree