Quality Specialist

About the Role

An innovative clinical-stage pharmaceutical company focusing on treatments for rare and orphan diseases is recruiting a Quality Specialist. This full-time position, reporting directly to the VP of Quality, involves overseeing quality aspects of outsourced drug substance manufacturing located in Sligo. The role supports the company's mission to develop solutions meeting significant unmet medical needs within a collaborative and expanding environment.

Responsibilities

• Serve as the sponsor's Person in Plant (PiP) at specific drug substance manufacturing facilities.
• Review batch manufacturing documentation to verify adherence to approved product dossiers and regulatory standards.
• Provide quality supervision and performance evaluation for third-party manufacturing partners through periodic engagement and quality metrics tracking.
• Contribute to quality risk assessments related to product changes, deviations, and quality incidents.
• Assist in creating, assessing, and updating Standard Operating Procedures (SOPs).
• Support investigations of temperature deviations and take part in shipping lane risk assessments and validation tasks.
• Offer general quality and compliance assistance as directed by the Vice President of Quality.
• Develop and maintain positive relationships with internal teams and external manufacturers to uphold high-quality standards and compliance.

Requirements

• Bachelor's degree in Chemistry or relevant scientific fields preferred.
• At least three years of pharmaceutical industry experience.
• Familiarity with small molecule pharmaceutical products favored.
• Experience collaborating with contract manufacturing organizations (CMOs) is advantageous.
• Solid knowledge of EU GMP regulations and pharmaceutical quality standards.
• Proven capability to interpret regulatory requirements and apply sustainable quality practices.
• Understanding of reviewing pharmaceutical batch documentation.
• Exposure to small molecule synthetic manufacturing processes is beneficial.
• Knowledge of quality risk management and pharmaceutical investigation procedures is a plus.
• Excellent communication skills, both oral and written.
• Strong organizational capabilities to independently handle multiple priorities.
• Self-driven with a proactive mindset toward resolving problems.
• Detail-oriented with a strong dedication to quality standards.
• Proficient in Microsoft Office suite.

Additional Information

• Competitive salary range from €45,000 to €55,000 based on experience.
• Remote work within the Sligo region with a requirement to visit the manufacturing facility weekly.
• Opportunity to engage with global contract manufacturing operations and cross-functional teams.
• Supportive and collaborative workplace promoting professional growth.