Senior Manager Quality, EM&S; Gen Med North America

Location: Framingham, Massachusetts, United States; hybrid. Open to domestic and international travel for 25–30% of the time.

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines for patients worldwide.

What you will do

• Provide quality and regulatory oversight for third-party manufacturers, suppliers, and contract laboratories.
• Ensure compliance with cGMPs, hirify.global Quality Directives, quality management systems, and regulatory filings.
• Lead or participate in subcontractor audits and manage resulting CAPAs, deviations, investigations, and change controls.
• Develop and negotiate subcontractor Quality Agreements and advise external partners on quality requirements.
• Support product launches, subcontractor onboarding and offboarding, validation reviews, and product complaint resolution.
• Identify and resolve quality issues affecting regulatory compliance, product supply continuity, and product disposition.

Requirements

• Bachelor’s degree in a science field.
• At least 3 years of experience in pharmaceutical or quality operations applying cGMPs in a regulated industry; co-op or internship experience may be considered.
• Technical knowledge of pharmaceutical quality assurance, GMPs, regulatory requirements, product complaints, and manufacturing processes.
• Experience with quality and regulatory functions for third-party manufacturing is preferred.
• Strong communication, teamwork, negotiation, project management, and problem-solving skills.
• Knowledge of French is preferred for communication with headquarters.

Culture & Benefits

• Supportive, future-focused environment centered on science, medicine, and vaccine delivery.
• Opportunities for promotion, lateral moves, international development, and cross-functional roles.
• Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Rewards and benefits package based on contribution and demonstrated experience.