QC Team Lead

Location:  Cork, Ireland Category: Quality

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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.

SUMMARY DESCRIPTION

BioMarin has a high-performing, team based organization, 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 excellent organizational skills.

 

RESPONSIBILITIES

The QC Lead reports to the QC Manager and is responsible for leading a team to meet deliverables these include testing of samples 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 BioMarin needs.

The main areas of responsibility of this role are as follows:
 

 

 

 

  • Lead a QC team to ensure consistent delivery to customers and provide technical expertise for all aspects of testing and out of specification investigations.
  • Responsible for leading development discussions with individuals within the team in areas of professional 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 performance management of the team.
  • Coach and develop individuals within the team.
  • Collaboration with QC Leads and Associates to ensure the overall running of the QC Laboratory.
  • Develop and maintain internal and external relationships and ensure customer satisfaction through effective communications.
  • Review and approve documentation such as standard operating procedures, training modules, protocols, reports and Trackwise documents.
  • Ensure the team is compliant to GxP, safety and environmental standards.
  • Conduct and document out-of-specification/out-of-trend result investigations.
  • Participate and or 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 QC and site operations.

Experience

  • Solid experience of environmental monitoring, clean utilities, microbial ID, plate reading, bioburden, endotoxin, verifications, growth promotion and in-process testing.
  • Previous people management experience.
  • Demonstrated experience of developing and leading teams.
  • Knowledge and experience of Sterile filling processes and equipment including aseptic processing.

 

Note:     This description is not intended to be all-inclusive or a limitation of the duties of the position.  It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

 



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.