Senior Quality Specialist General Medicine (Pharmaceutical Quality)

Location: Framingham, Massachusetts, United States. This is a full-time onsite VIE assignment. The program is available to citizens of the European Economic Area aged 18–28, and candidates cannot apply for an assignment in their own country of citizenship.

Company

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

What you will do

• Ensure quality and regulatory compliance for products manufactured by external subcontractors in line with cGMPs and hirify.global quality directives.
• Manage quality systems covering complaints, deviations, change controls, non-conformities, production, testing, and product release or disposition.
• Support quality and regulatory strategy, crisis management, and implementation of corrective action plans.
• Conduct and participate in contractor audits and manage resulting CAPAs within the External Manufacturing North America audit program.
• Manage projects including new product launches and subcontractor or product onboarding and offboarding.
• Develop and negotiate subcontractor Quality Agreements and provide quality guidance to external partners.

Requirements

• 1–3 years of experience in pharmaceutical operations or quality operations in a regulated industry, applying cGMPs.
• Experience in third-party manufacturing quality or regulatory functions, or relevant site experience.
• Bachelor’s degree in science or a related field.
• Knowledge of pharmaceutical quality assurance, product complaints, GMPs, regulatory requirements, and drug product manufacturing across oral, semi-solid, liquid, injectable, lyophilized, and medical drug/device combination products.
• Strong communication, teamwork, negotiation, interpersonal, and project management skills.
• Fluent English, written and verbal, is required; applications must be submitted in English.

Culture & Benefits

• Work within a global manufacturing and supply network supporting medicines and vaccines.
• Collaborate with multidisciplinary teams across quality, supply chain, manufacturing science and technology, regulatory, and external manufacturing organizations.
• Participate in the iMove international development program for European youth, with assignments across global hirify.global functions and locations.
• Work with AI, robotics, digital technologies, and next-generation automation in biopharmaceutical manufacturing and supply.