Senior Manager Corporate Quality Compliance (Biotech)

Location: United States - Remote; approximately 50% domestic and international travel required.

Annual salary: USD 138,264.40–187,063.60

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Coordinate and lead or participate in global quality compliance audits covering corporate quality systems, sites, contract facilities, affiliates, service providers, suppliers, partners, and wholesalers.
• Assess regulatory compliance, identify significant risks, and support annual audit planning and audit metrics.
• Evaluate compliance status and action plans, and provide technical and organizational leadership to resolve site and multi-site issues.
• Support domestic and international regulatory authority inspections and serve as a subject matter expert on regulated requirements and inspection commitments.
• Represent Global Quality Compliance on cross-functional teams and align company standards with regulations and regulatory expectations.
• Own or perform quality assurance approval for quality incidents, deviations, CAPAs, change controls, and other DQMS quality event records.

Requirements

• Doctorate degree with 2 years of auditor experience, master’s degree with 6 years, bachelor’s degree with 8 years, associate’s degree with 10 years, or high school diploma/GED with 12 years of auditor experience.
• At least 2 years of direct people management or leadership experience leading teams, projects, programs, or resource allocation.
• Experience with aseptic processing, drug product, drug substance, combination products, and data integrity.
• Knowledge of international regulations and standards, with experience supporting regulated quality systems and inspections.
• Certified Quality Auditor certification or equivalent preferred.
• Must be based in the United States; approximately 50% international and domestic travel is required.

Culture & Benefits

• Collaborative, innovative, and science-based work environment focused on serving patients.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time-off plans, career development opportunities, and flexible work models where possible.