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.
If you are interested in discussing this role, please reach out to Darragh by email: darragh.mccathy@hrmrecruit.com
