Inspection Readiness Lead (TEMPORARY)Location 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 Inspection Readiness Lead reports to the Manufacturing Manager and will lead the inspection readiness team within manufacturing. The lead will be committed to team development, continuous improvement and compliance. A high level of initiative, influencing 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.
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 a team in the implementation of compliance elements of manufacturing goals.
- Lead preparation for regulatory and corporate audits;
- Anticipate questions and focus areas
- 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.
- 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 manufacturing 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 the inspection readiness team and influence manufacturing colleagues to achieve deliverables, including but not limited to:
- Report, monitor and improve compliance metrics within MFG
- 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 the manufacturing leadership team and quality.
- Talent management – hire, performance manage and coach individuals within the team. Develop a highly engaged, high performing team.
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.