Qualified Person

HRM Search Partners; Limerick; On-site; EUR 120,000 - 170,000; Full time

Job summary

HRM Search Partners is seeking an experienced Qualified Person to oversee batch certification and regulatory authorization at our next-generation biopharma manufacturing site. You will collaborate with multiple departments, supervise technical QA activities, and provide mentorship to QA teams to ensure cGMP compliance and robust quality governance.

The role requires a licensed QP, a Level 7 degree or higher in science or engineering, and at least 6 years in biopharma, with travel 0-10% and

Qualifications

• Licensed QP approved by a member state.
• Level 7 degree or higher in Science/Engineering or related field.
• Minimum 6 years of relevant biopharmaceutical experience.
• Strong knowledge of cGMP, FDA, data integrity, and quality risk management.

Responsibilities

• Executes final batch certification and release decisions for drug substance and drug product.
• Reviews and approves change controls, deviations, investigations, investigations, stability reports and validation packages.
• Provides quality governance, mentors QA teams, maintains Annex 16 competency, and enforces site safety policies.
• Oversees GMP compliance, key quality programs, and the Site Self-Inspection audit program.
• Issues QP declarations and ensures compliance with renewed regulatory authorisations.

Skills

Independent work

Project management

Technical documentation

Influence without authority

Executive presentations

Education

Licensed QP approved by a member state

Level 7 degree or higher in Science/Engineering or related field

Job description

The position plays a pivotal role in ensuring the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. This position is responsible for implementing and executing batch approval and regulatory authorisation for the site. The Qualified Person will collaborate with various departments to support the technical agenda and serve as a technical mentor for the site quality assurance teams.

Responsibilities

• Batch Certification: Executes final certification and batch release decisions for drug substance and drug product in compliance with regulations and authorisations (IND, CTAS, BLA, MAAs).
• Quality & Validation Approval: Reviews and approves change controls, deviations, investigations, complaints, stability reports, and validation packages (IQ/OQ/PQ, equipment, computer systems, utilities).
• Technical Leadership & Oversight: Provides quality governance, mentors QA teams, maintains Annex 16 competency, and enforces site safety policies.
• Quality Monitoring: Oversees GMP compliance, key quality programs, and the Site Self-Inspection audit program.
• Regulatory Support: Issues QP declarations and ensures compliance with renewed regulatory authorisations.

Experience & Qualifications

• Licensing & Education: Licensed QP approved by a member state; Level 7 degree or higher in Science, Engineering, or a related field.
• Work Experience: Minimum 6 years of relevant experience in a biopharmaceutical environment.
• Regulatory Expertise: Strong working knowledge of cGMP, FDA, Data Integrity, and Quality Risk Management.
• Core Competencies: Proven ability to work independently, manage multiple concurrent projects, write technical documentation, influence without authority, and present to senior leadership.
• Working Conditions: Willingness to travel (0-10%) and be on call as needed.