QC Team Lead
Description
Who We Are
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our Culture
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
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.
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our Culture
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
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.
QC Team Lead - Shanbally, Ringaskiddy, Cork
Day role - Monday to Friday
Closing Date 3rd May 2024
"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 to meet QC metrics and commitments. Together with the QC Manager, this role is responsible for ensuring the area architecture and vision is in place to meet the needs of BioMarin.
This role sits in the QC In-Process and Raw Material group. Part of the QC In-Process and Raw Material team operates on a 4 shift 24/7 basis. This role is a days (Mon-Friday) role but will have direct report who operate on 4 cycle shift. This is a face paced team with a high volume of work to be completed in tight timelines.
Role Responsibilities
Responsibilities including but are not limited to the following:
- Lead a high performing QC team to ensure consistent delivery to customers and provide technical expertise and decision making for all aspects of testing and out of specification investigations.
- 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/managers to ensure the overall running of the QC Laboratory
- Develop and maintain positive internal and external relationships across the site.
- Redline, Author, Draft, Review and Approve documents such as standard operating procedures, protocols, reports etc.
- Ensure the team is compliant to GXP and safety and environmental standards
- Conduct and document out of specification / out of trend result investigations and deviations in the quality management system.
- 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
- Other duties as assigned.
Education Required
- Bachelor of Sciences degree, or higher, in a technical discipline (chemical or biological sciences, physical, engineering) is minimally required.
Experience Required
- Team leadership and people management experience is strongly preferred, Ideally 3+ years of experience.
- 5 + years of experience in pharma or biopharma industry at a minimum.
- Good project management skills
- Experience in presenting to senior management
- Lead from front attitude
- Thorough knowledge of regulatory guidelines and directives for QC in pharmaceuticals.
- Data orientated with good risk management understanding
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.