Senior Manager Quality Assurance (Biotechnology)

Location: Juncos, Puerto Rico, 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 Major Deviations Lifecycle Team, including coaching, performance management, employee development, and resource planning.
• Provide strategic oversight of complex deviation investigations, root cause analyses, risk assessments, CAPAs, and effectiveness verification.
• Ensure deviations are initiated, investigated, approved, documented in the digital quality management system, and closed within required timelines.
• Partner with Quality Assurance, Quality Control, Manufacturing, Engineering, Supply Chain, Regulatory Affairs, Process Development, EHS, and Validation teams.
• Monitor deviation trends and quality metrics, identify systemic issues, and lead continuous improvement programs.
• Support audits and regulatory inspections while maintaining compliance with cGMP, data integrity expectations, FDA, EMA, and global quality standards.

Requirements

• Doctorate degree plus 2 years of quality support experience; or master’s degree plus 6 years; bachelor’s degree plus 8 years; associate’s degree plus 10 years; or high school diploma/GED plus 12 years.
• At least 2 years of direct people management or leadership experience involving teams, projects, programs, or resource allocation.
• Experience in quality assurance, quality systems, manufacturing, or compliance within pharmaceutical, biotechnology, or another regulated industry.
• Strong understanding of cGMP regulations and FDA, EMA, and global regulatory expectations.
• Strong analytical, problem-solving, decision-making, communication, organizational, and stakeholder-management skills.
• Role location: Juncos, Puerto Rico, United States.

Nice to have

• Educational background in life science and/or engineering.
• 8+ years of experience in quality assurance, quality systems, manufacturing, or compliance.
• Experience managing major deviations, investigations, CAPAs, regulatory interactions, inspection readiness, and regulatory audits.
• Knowledge of electronic quality systems, data-trending tools, deviation investigation methodologies, and quality risk management.
• 3+ years of leadership or people management experience in a fast-paced, highly regulated environment.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, and disability insurance for eligible employees and dependents.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time-off plans, work-life balance support, and career development opportunities.
• Flexible work models where applicable to the role.