Sr. Specialist Manufacturing (Biotechnology)

Location: West Greenwich, Rhode Island, United States

Company

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

What you will do

• Lead the site’s most complex, high-impact, and regulatory-significant major deviation investigations from initiation through closure.
• Direct in-field investigation activities, coach investigation teams, and ensure rigorous fact-finding and science- and risk-based outcomes.
• Serve as a subject matter expert by mentoring colleagues, sharing knowledge, and applying 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, emerging technologies, and AI-enabled investigation tools.

Requirements

• High school diploma/GED and 12 years of Quality and/or Manufacturing experience; or an associate degree and 10 years; bachelor’s degree and 6 years; master’s degree and 4 years; or doctorate degree and 2 years.
• Expertise in deviation management systems, root cause investigations, CAPA strategy, and quality system processes in a GMP-regulated environment.
• Experience serving as a technical representative during internal audits and regulatory inspections.
• Ability to lead complex cross-functional projects, balance multiple priorities, and deliver within established timelines.
• Strong written, verbal, and presentation skills, with the ability to influence stakeholders and explain complex concepts clearly.
• Ability to build trusted partnerships and influence cross-functional teams 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.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time off and career development opportunities.
• Flexible work models where applicable to the role.

Hiring process

• Applications are accepted until a suitable candidate is selected.
• Reasonable accommodations are available during the application and interview process.