Senior Manager Quality, EM&S Gen Med North America (Pharmaceutical Quality)

Location: Framingham, Massachusetts; hybrid. US and Puerto Rico residents only. The role includes 25–30% domestic and international travel.

Salary: $90,000–$130,000 per year.

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, contract laboratories, and other subcontractors.
• Manage quality-system activities involving complaints, deviations, change controls, non-conformities, investigations, and product release or disposition.
• Lead or participate in contractor audits and manage resulting CAPAs in accordance with cGMPs, hirify.global directives, and regulatory filings.
• Develop and negotiate subcontractor Quality Agreements and provide quality guidance on compliance issues.
• Support product launches, subcontractor onboarding and offboarding, validation reviews, and manufacturing continuity initiatives.
• Collaborate with quality, supply chain, MSAT, regulatory, legal, technical, analytical, and international affiliate teams to resolve complex quality risks.

Requirements

• Bachelor’s degree in a science field.
• At least 3 years of experience in pharmaceutical operations or quality operations within a regulated industry.
• Significant knowledge of pharmaceutical quality assurance, cGMPs, regulatory requirements, product complaints, and quality systems.
• Experience with third-party manufacturing quality and regulatory functions, audits, investigations, CAPAs, and quality agreements.
• Knowledge of drug-product manufacturing across oral dosage forms, semi-solids, liquids, injectables, lyophilized products, and medical drug/device combinations.
• Project management, communication, teamwork, negotiation, and stakeholder-management skills; openness to 25–30% domestic and international travel.

Nice to have

• Co-op or internship experience.
• Knowledge of French for communication with headquarters.

Culture & Benefits

• Supportive, future-focused environment centered on medicines, vaccines, and scientific innovation.
• Opportunities for promotion, lateral moves, international development, and cross-functional experience.
• Healthcare, prevention, wellness, and other employee benefits.
• At least 14 weeks of gender-neutral parental leave.
• Workplace focused on inclusion, growth, and continuous improvement.