Senior Quality Assurance Compliance Specialist

Location: On premise in Rochester, Michigan, United States. Candidates must have permanent authorization to work in the United States. U.S. work visa sponsorship is not available.

Annual base salary: $82,700–$137,900, plus eligibility for a 10% performance bonus.

Company

hirify.global develops and manufactures pharmaceutical products with a focus on patient safety, product quality, and regulatory compliance.

What you will do

• Evaluate CAPA responses to internal and external audit observations and verify timely, effective completion.
• Maintain quality policies, procedures, records, and metrics in compliance with cGMP, regulatory, corporate, and site requirements.
• Prepare for and support regulatory inspections, internal audits, supplier audits, and quality assessments.
• Manage customer complaints for commercial drug products, including investigations, root cause analysis, and quality decisions.
• Support supplier qualification, performance monitoring, corrective actions, risk assessments, and issue escalation.
• Conduct or support technical investigations, deviation and change management, data trending, effectiveness verification, and continuous improvement.

Requirements

• High school diploma with 8+ years of experience, associate’s degree with 6+ years, BA/BS with 2+ years, or MBA/MS with relevant experience.
• Experience conducting and documenting quality investigations in pharmaceutical or medical device manufacturing.
• Strong understanding of quality systems, manufacturing and packaging processes, validation, engineering drawings, and basic statistics.
• Ability to apply statistics and probability to quality engineering tasks.
• Strong technical writing, communication, presentation, audit, and inspection skills.
• Proficiency with Microsoft Office, Microsoft Project, and statistical software.

Nice to have

• Experience handling complaints and using electronic laboratory systems.
• Experience mentoring and training colleagues.
• Experience using generative AI tools such as Microsoft Copilot, with understanding of responsible AI, risk management, and ethical use.

Culture & Benefits

• Patient-focused, science- and risk-based quality culture.
• 401(k) matching and an additional retirement savings contribution.
• Paid vacation, holidays, personal days, caregiver and parental leave, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Relocation assistance may be available based on business needs and eligibility.