QC Release - Manager

Location:  Cork, Ireland Category: Manufacturing

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.

The Role

 

The Quality Control Release 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.

 

RESPONSIBILITIES

  • Lead the laboratory personnel responsible for testing and disposition of drug substance and drug product.
  • Develop and lead the QC team in areas of expertise, use of operational excellence tools, and high performance team behaviours.
  • Manage the QC Release team to ensure testing of Drug Substance and Drug Product to market.
  • Manage the QC Release team to ensure testing and compliance to our stability programs.
  • 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.
  • Maintain the laboratory in an inspection-ready state.
  • Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives
  • Participate in budget planning. Communicate capital equipment needs, facility needs, staffing needs; and contract service requirements.
  • Identify and conduct personnel training for quality control personnel, prepare performance appraisals and recruit staff.

 

EDUCATION

M.Sc. with at least 8 years of experience in a relevant functional area, or a B.Sc. with at least 10 years experience in a relevant functional area (at least 2 years in Quality Control).

  

CONTACTS

This position will interact with all other departments throughout the organization

 

MANAGER RESPONSIBILITY

3-4 Team Lead/Associate direct reports with their associated teams.



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.