QC Analytical Team LeadLocation Cork, Ireland Workstyle Open to Hybrid 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.
We are 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, as well as organisational skills.
The QC lead reports to the QC manager and is responsible for leading a team in order to meet deliverables. These include testing of samples in order to meet QC metrics, and release commitments. Together with the QC Manager, this role is responsible for ensuring the department architecture and vision is in place to meet the needs of Biomarin.
The role will cover Analytical testing for QC Release and Stability testing - including but not limited to the following:
- Lead a QC team to ensure consistent delivery to customers and provide technical expertise for all aspects of testing and out of specification investigations
- Provide technical expertise for out of specification investigations and all aspects of testing
- Coach and develop individuals within the team
- Responsible for leading development discussions with individuals within the team in areas of professionalism and personnel development
- Responsible for overall performance of the team in areas of technical delivery and inter-team and inter-department collaboration
- Responsible for the hiring and the performance management of the team
- Collaboration with QC leads to ensure the overall running of the QC Laboratory
- Develop and maintain both internal and external relationships
- Ensure customer satisfaction through effective communication
- Review and approve documents such as standard operating procedures, protocols, reports and track-wise documents
- Ensure the team is compliant to GXP and safety and environmental standards
- Conduct and document out of specification / out of trend result investigations
- Participate and ensure support for cross-functional teams
- Provide QC support for site plans, protocol executions and summary reports
- Develop and Demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
- Lead and implement initiatives that add value to the QC and site operations
- Bachelor of Sciences degree, or higher, in a technical discipline (chemical or biological sciences, physical, engineering) is required.
- Must have team leadership and people management experience
- Technical experience within at least one of the following areas: Separations / Plates / Bioassay
- Good project management skills
- Experience in presenting to senior management
- Lead from front attitude
- Thorough knowledge of regulatory guidelines and directives
- Data orientated with good risk management understanding
- Consultants / Contractors reporting to it on a project basis
- Achieving Excellence
- Courage / Challenge
- Develop Self & Others
- Technical Knowledge & Expertise
- Attention to Detail
- IT Applications
- Workload & Time Management
- Performance management
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.