Quality Document Control Lead—GMP & Compliance

Biovire, Inc.; Brighton Charter Township (MI); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Paid Time Off

Job summary

Biovire, Inc. seeks a Quality Document Control Supervisor to lead the QDC team onsite in Brighton, Michigan. You will manage controlled documents, issue Master Batch Records, revise procedures, and support regulatory audits while ensuring accurate, compliant documentation across manufacturing.

The role requires 2+ years in pharma, an associate degree, and strong attention to detail with MS Word and PDF tools. This is a hands-on leadership position within a growing GMP environment.

Qualifications

• Associate degree or equivalent with relevant work experience in pharma.
• Minimum of 2 years in pharmaceutical or regulated environment.
• Experience with controlled document management systems.
• Knowledge of cGMP, 21 CFR parts 11/210/211/820 and ICH guidance.
• Detail-oriented with strong organizational and communication skills.

Responsibilities

• Oversee day-to-day QDC function, team workflow, priorities, and deliverables.
• Develop and issue Master Batch Records and revisions.
• Create and control SOPs, forms, and protocols.
• Issue controlled copies of batch records and track issuance.
• Collaborate with Process Engineering to support new products.
• Maintain issuance records, logs, and master files.
• Oversee periodic review of controlled documents.
• Manage change controls and drive document changes to completion.
• Oversee archival and retention of controlled docs.
• Support audits by regulators, customers, and others.
• Generate QDC metrics for monthly management review.
• Maintain Good Documentation Practices across records.
• Participate in cross-functional quality initiatives.
• Identify opportunities to strengthen processes.
• Ensure activities meet safety, cGMP, SOPs and regulatory expectations.

Skills

Leadership

Organizational skills

Attention to detail

Written and verbal communication

Independence

Cross-functional collaboration

Education

Associate degree

Tools

Microsoft Word

Adobe Acrobat

Job description

Biovire, Inc. seeks a Quality Document Control Supervisor to lead the QDC team onsite in Brighton, Michigan. You will manage controlled documents, issue Master Batch Records, revise procedures, and support regulatory audits while ensuring accurate, compliant documentation across manufacturing.

The role requires 2+ years in pharma, an associate degree, and strong attention to detail with MS Word and PDF tools. This is a hands-on leadership position within a growing GMP environment.