Qualified Person — cGMP Compliance & Batch Release Lead

Tandem Project Management Ltd.; Waterford; On-site; EUR 95,000 - 135,000; Full time

Job summary

A Qualified Person is required on site in Waterford for a biopharmaceutical company. The role ensures that manufacturing and release comply with EU cGMP directives and regulatory guidance, preserving product quality and safety.

You will certify licensed product, manage batch disposition for timely release, support investigations, and contribute to cross-functional teams while maintaining independence in quality decisions.

Qualifications

• Advanced degree in a relevant field (MSc or equivalent).
• 8+ years in cGMP with experience as Qualified Person.
• Proven leadership with at least 2 years of management responsibility.
• Biologics manufacturing experience desirable.
• Sterile manufacturing or clinical trials regulation experience desirable.
• Strong training/mentoring experience.
• Excellent oral and written communication skills.
• Strong problem solving, risk assessment and impact analysis abilities.

Responsibilities

• Ensure licensed product is certified and released by the QP on the MIA in accordance with EU directives.
• Manage the batch disposition process to ensure timely release.
• Maintain compliance of batch disposition with site practices and regulatory requirements.
• Support investigations and ensure deviations are closed prior to release.
• Participate in cross-functional teams as Quality/QP representative.
• Provide QP support on quality issues as needed.
• Engage in internal committees and provide guidance to other departments.
• Ensure independence of QP decisions on quality matters.

Skills

Leadership

Regulatory knowledge

Quality assurance

Communication

Problem solving

Education

MSc or equivalent

Job description

A Qualified Person is required on site in Waterford for a biopharmaceutical company. The role ensures that manufacturing and release comply with EU cGMP directives and regulatory guidance, preserving product quality and safety.

You will certify licensed product, manage batch disposition for timely release, support investigations, and contribute to cross-functional teams while maintaining independence in quality decisions.