Inspection Readiness Lead, Fill FinishLocation Cork, Ireland Apply
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 Drug Product Inspection Readiness lead will lead the inspection readiness within operations. The lead will be committed to team development, continuous improvement and compliance. A high level of initiative, influencing, coaching and questioning skills are key role requirements, as well as excellent organisational skills. The role presents a great opportunity for a candidate with experience in Quality to transition to Manufacturing, or conversely someone in a manufacturing position to transition to a role with more of a quality focus. During the initial stages of the project, the lead will support the team with operational readiness activities before moving into routine operational support. This facility will contain a state-of-the-art flexible line using isolator technology for filling of vials and syringes and the facility will support both clinical and commercial filling for the majority of the BioMarin biologics product portfolio.
BioMarin has a high-performing, team based organisation, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements. The Inspection Readiness Lead reports to the Drug Product Operations Manager and will lead the inspection readiness within operations.
Main areas of responsibility:
- Provide guidance on compliance and regulations and build competency within the manufacturing team.
- Develop and maintain an internal compliance programme within Manufacturing.
- Lead in the implementation of compliance elements of manufacturing goals.
- Lead preparation for regulatory and corporate audits;
- Anticipate questions and focus areas related to ICH and Annex 1 guidelines.
- Interrogate systems and processes to confirm areas of strength and identify potential issues and planning responses
- Foster high expectations and unrelenting persistence towards continued audit success
- Generate responses to audit findings
- Lead and participate in self-inspections and compliance walk-throughs of manufacturing.
- Demonstrate a strong task focus. Use data analysis to identify problem areas and drive implementation of improvements and initiatives.
- Foster a quality focused environment through inspection readiness coaching support.
- Liaise with global support team to share learnings and implement improvements at a company wide scale.
- Responsible for reporting, monitoring and improving compliance metrics for the operations team.
- Demonstrate a quality focused approach to decisions in manufacturing. Consider site wide impact and solutions to issues/decisions.
- Use risk assessment and problem-solving tools to contribute to quality / compliance-related investigations / continuous improvements initiatives
- Lead & influence manufacturing colleagues to achieve deliverables, including but not limited to:
- Report, monitor and improve compliance metrics within operations
- Effective documentation lifecycle management
- Create a permanent audit readiness state and a zero-late mindset
- Implementation of projects and initiatives to improve compliance metrics and audit preparedness
- Develop effective working relationships with key stakeholders including Operations, Maintenance and Quality.
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.