Senior Specialist – Complex Investigations (Biotechnology)

Location: Holly Springs, North Carolina, United States

Salary: $137,263.10–$185,708.90 annually

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines, including products produced at its advanced biologics drug substance manufacturing facility in North Carolina.

What you will do

• Lead the most critical and complex deviation investigations across the biologics drug substance manufacturing site.
• Investigate significant quality events, recurring deviations, product-impacting events, and systemic compliance issues with cross-functional teams.
• Apply Kepner-Tregoe, Quality Risk Management, 5-Why, Fishbone Analysis, and data-driven problem-solving methods.
• Drive CAPA development, assess action effectiveness, and identify recurring trends and site-wide improvement opportunities.
• Present investigation findings, risks, recommendations, and remediation activities to site leadership and governance teams.
• Support regulatory inspections and internal audits while improving investigation processes, metrics, tools, and standards.

Requirements

• Doctorate degree and 2 years of directly related experience; or a master’s degree and 4 years; bachelor’s degree and 6 years; associate’s degree and 10 years; or high school diploma/GED and 12 years.
• Extensive experience leading complex investigations in a regulated biotechnology or pharmaceutical environment.
• Strong knowledge of GMP regulations, quality systems, deviation management, CAPA systems, and regulatory expectations.
• Expertise in root cause analysis, quality risk management, data-driven decision-making, and technical writing.
• Ability to influence cross-functional teams and senior leadership, mentor investigators, and manage investigation metrics and closure.
• Preferred academic backgrounds include microbiology, biology, chemical engineering, biochemistry, or a related science or engineering discipline.

Nice to have

• Seven or more years of biotechnology or pharmaceutical industry experience with progressively increasing responsibility.
• Experience with Veeva QMS for investigations and CAPA management.
• Experience presenting as a subject-matter expert during regulatory inspections and internal audits.

Culture & Benefits

• Health, dental, vision, life, disability, and flexible spending benefits for employees and eligible dependents.
• Retirement and savings plan with company contributions, stock-based long-term incentives, and an annual bonus program.
• Paid time-off plans and twice-yearly company-wide shutdowns.
• Career development opportunities and flexible work models where applicable.