Sr. Specialist Manufacturing (Biotech)

Location: US - Rhode Island - West Greenwich; onsite manufacturing role

Annual salary: USD 137,263.10–185,708.90

Company

hirify.global is a biotechnology company that researches, manufactures, and delivers medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead major deviation investigations from initiation through closure as the technical owner for complex, high-impact, and regulatory-significant cases.
• Conduct in-field fact-finding, coach investigation teams, and drive science- and risk-based outcomes.
• Provide subject matter expertise through mentoring, knowledge sharing, and advanced investigation methodologies.
• Partner with manufacturing, engineering, process development, quality control, supply chain, regulatory affairs, and quality organizations on critical quality issues.
• Represent the organization during internal audits, regulatory inspections, and health authority interactions.
• Lead continuous improvement initiatives involving quality systems, data analytics, AI-enabled investigation tools, and digital solutions.

Requirements

• High school diploma/GED with 12 years of Quality and/or Manufacturing experience, or an associate’s degree with 10 years, bachelor’s degree with 6 years, master’s degree with 4 years, or doctorate degree with 2 years of relevant experience.
• Expertise in deviation management, root cause investigations, CAPA strategy, and quality system processes in a GMP-regulated environment.
• Experience presenting and defending investigation records and quality decisions during audits and regulatory inspections.
• Ability to lead complex cross-functional projects, balance priorities, and deliver within established timelines.
• Strong written, verbal, and presentation skills, with the ability to influence stakeholders without formal authority.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual discretionary bonus and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.
• Flexible work models where applicable; the role’s work location is specified above.