Lead Quality Document Control & Compliance

Biovire, Inc.; Michigan; On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Paid Time Off

Job summary

Biovire, Inc. in Brighton, Michigan seeks a Quality Document Control Supervisor to lead the QDC function for pharmaceutical drug product and medical device manufacturing.

Reporting to the Senior Manager, Quality Systems, you will manage master batch records, SOPs, change controls, and audits, ensuring compliance with cGMP and 21 CFR. This hands-on leadership role requires strong organization and cross-functional collaboration.

Qualifications

• Minimum 2 years in pharmaceutical or regulated environment.
• Experience with a controlled document management system.
• Knowledge of cGMP, Good Documentation Practices, and applicable regulatory principles.
• Strong attention to detail and ability to organize and prioritize work.

Responsibilities

• Oversee day-to-day Quality Document Control function and team workflow.
• Develop and revise Master Batch Records and batch record revisions.
• Create, revise, and control SOPs, forms, protocols, and other controlled documents.
• Issue controlled copies of batch records and track issuance.
• Support audits and regulatory inspections.
• Generate QDC metrics for monthly reporting and management review.
• Maintain Good Documentation Practices across controlled records.
• Lead cross-functional quality initiatives and process improvements.

Skills

Leadership

Attention to detail

Organizational skills

Communication

Independent work

Education

Associate degree or equivalent combination of education and relevant work experience

Tools

Microsoft Word

Adobe Acrobat

PDF documents

Job description

Biovire, Inc. in Brighton, Michigan seeks a Quality Document Control Supervisor to lead the QDC function for pharmaceutical drug product and medical device manufacturing.

Reporting to the Senior Manager, Quality Systems, you will manage master batch records, SOPs, change controls, and audits, ensuring compliance with cGMP and 21 CFR. This hands-on leadership role requires strong organization and cross-functional collaboration.