Qualified Person (QP)Location Cork, Ireland
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The Qualified Person (QP) is responsible for fulfilling QP responsibilities in relation to batch release of commercial (product for sale or supply in the EU or for export) and clinical product, in accordance with the requirements of EC/2001/83, EC2001/20 and Annex 16 and 13 requirements, as applicable.
The Qualified Person (QP) is responsible for fulfilling QP responsibilities in relation to batch release of Products that are Manufactured at BioMarin facilities and/or Contract Manufacturing Organizations.
The Qualified Person (QP) is responsible for ensuring that, prior to the certification of any given batch of formulated bulk drug substance, drug product and finished goods, each batch has been manufactured and tested in accordance with the requirements of its Marketing Authorization or Product Specification file and the principles of current Good Manufacturing Practice (cGMP) prior to final release of the batch.
The QP is responsible for the Quality oversight of contract manufacturers, testing and for leading, monitoring and supporting the quality performance of quality systems according to GMP standards.
The QP will take part in Material Review Boards, CMO Quality Reviews, Supply planning and Product Governance Meetings.
The QP will partner with departments across BioMarin and with CMO’s providing Quality Oversight of CMO’s.
- QP Qualification, M.Sc. with at least 8 years of experience, or a B.S. with at least 10 years’ experience in an EU licensed facility in a relevant functional area. QP Qualification, M.Sc. with at least 8 years of experience, or a B.S. with at least 10 years’ experience in an EU licensed facility in a relevant functional area.
- 8+ years’ experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in Quality Assurance, Batch Release and Compliance.
- Maintain knowledge up-to-date with respect to the current Good Manufacturing Practices (cGMP), technologies and quality systems for the products they certify.
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Understanding and familiarity with European regulatory requirements, guidelines, and expectations.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.