Sr. Mgr External Quality (Pharmaceutical)

Location: Ireland – Dublin, hirify.global Dun Laoghaire

Salary: €91,082.60–€123,229.40 per year

Company

hirify.global is a biotechnology and pharmaceutical company developing and manufacturing medicines.

What you will do

• Provide quality oversight for the manufacturing, testing, release, and disposition of hirify.global products at contract manufacturing organizations and laboratories.
• Act as the main Quality contact for deviations, change controls, CAPAs, complaints, quality agreements, and batch disposition.
• Review production batch records, master batch records, and other cGMP documentation from contract manufacturers and laboratories.
• Manage contract manufacturers against quality agreements, hirify.global specifications, safety, regulatory, and contractual requirements.
• Support new product introduction, technology transfers, process performance qualification, regulatory filings, inspections, and notified body audits.
• Monitor quality metrics, identify and mitigate risks, maintain inspection readiness, and escalate roadblocks to management.

Requirements

• 10+ years of experience in the biotechnology or pharmaceutical industry.
• Significant Quality experience in aseptic manufacturing facilities.
• Ability to facilitate and influence senior stakeholders, negotiate strategic positions, and work effectively in a matrixed environment.
• Strong project management, problem-solving, analytical, collaboration, and communication skills.
• Experience leading cross-functional teams, driving issue resolution, and using DAI principles for decision-making.
• Familiarity with variation management; QP eligibility is desirable.

Nice to have

• Additional European languages.
• QP eligibility.
• Familiarity with basic project management tools.

Culture & Benefits

• Full-time employment under a specified purpose contract for 12 months.
• Cross-functional collaboration with Quality, Production, Regulatory, Logistics, Supply Chain, Analytical Science, and Process Development teams.
• Regular interaction with contract manufacturing and testing partners.