QC Process Monitoring - ManagerLocation 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 Quality Control Manager reports to the Head of QC, and is responsible for leading laboratory personnel. There are multiple functional teams within the QC department from IPC, EM, testing and disposition of drug substance and drug product and associated stability programs as well as support functions including equipment introduction/validation, training and compliance.
It is expected that the incumbent will lead in a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
The incumbent must possess technical expertise in the areas of responsibility and demonstrate technical and personnel leadership qualities. In addition, this role is responsible for providing strong leadership, co-ordination and alignment between the key functions of QA, QC, manufacturing, Supply Chain, and the JCMO Teams, to agree and deliver upon monthly commitment dates for batch release aligned with the Supply Plan and Quality Capacity. In addition, this role is responsible for providing strong leadership, co-ordination and alignment between the key functions of QA, QC, manufacturing, Supply Chain, and the JCMO Teams, to agree and deliver upon monthly commitment dates for batch release aligned with the Supply Plan and Quality Capacity.
- Lead the QC functional teams to operate in compliance to current standards at all times.
- Develop and lead the QC team in areas of expertise, use of operational excellence tools, and high performance team behaviours.
- Manage the QC Process Monitoring teams of QC In Process Control and QC Microbiology.
- Manage an equipment team to ensure appropriate equipment lifecycle, service programs and new equipment introductions.
- Provide technical expertise and leadership to the QC group ensuring samples are tested under cGMP within specified timelines.
- Provide oversight of out-of-specification/out-of-trend result investigations and documentation of same.
- Interface with other BioMarin departments (Regulatory Affairs, Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary.
- Participate as required in global project teams relating to QC and wider quality activities.
- Maintain the laboratory in an inspection-ready state.
- Participate in budget planning. Communicate capital equipment needs, facility needs, staffing needs; and contract service requirements.
- Negotiate and manage SLAs with key customers as required.
- Support budget preparation and monitoring, capacity planning, facility needs, demand planning, monitoring spend versus budget, latest estimate etc.
- Identify and conduct personnel training for quality control personnel, prepare performance appraisals and recruit staff.
- As required, act as designee for the Head of QC in their absence.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for process validation expectations.
- Previous experience in managing the performance of individual team members and that of the overall team
- Knowledge and experience of Lean Laboratories is preferable
M.Sc. with at least with at least 10 years of experience in a relevant functional area, and minimum of 5 years QC Laboratory Management experience
3-4 Team Lead/Associate direct reports with their associated teams.
This position will interact with all other departments throughout the organization
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.