Director, QA Operations - External Quality

Location:  Cork, Ireland Category: Quality

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. Come join our team and make a meaningful impact on patients’ lives.

The Director of QA Operations is a highly motivated technically knowledgeable leader with proven abilities to direct quality assurance activities across multiple external business partners for Technical Operations (TOPS). The successful candidate will strengthen the Quality culture and ensure the manufactured product meets all company standards and government regulations. This leader will develop a high performing team and provides leadership and guidance to the organization. By providing strategic direction, setting clear expectations, goals and metrics, the leader is accountable for quality activities related to all phases of production generated at our Contract Manufacturing Sites. These products span different platforms including biologics, devices, gene therapies, oligonucleotides, and small molecules. The leader would champion continuous improvement to reduce variability in production and to maintain high quality product. 

This position requires a broad range of knowledge and experience with biologic processes, drug development, analytical testing methods, and understanding of the international regulatory landscape. Accountabilities include lot disposition decisions, master label approvals, and management of Quality Technical Agreements with external parties. The Director of QA Operations will build strong Quality to Quality relationships with Contract Manufacturing Organization (CMO) sites, to ensure effective communications and oversight of CMO operations. The incumbent is expected to work with upstream and downstream functions to resolve issues, improve relevant business processes and systems. 

 
The Director of QA Operations will report to the External Quality Site Head, and is responsible for, Contract Manufacturing Organization Quality Assurance, and QP Certification. This position will sit on the External Quality Leadership Team. 

Travel of 15-20% may be required. 

SCOPE 

People Leader, with a team of ~20 people, in multiple global locations and time zones, all working to make quality product for patients. 

The responsibilities in the role include the following: 

  • Direct QA Operations to provide quality oversight of Contract Manufacturing, and supporting operations including, but not limited to: 
  • Oversight of manufacturing and warehouse operations for adherence to GMP. 
  • Review of documentation from manufacturing, QC, including logs, batch records, test records, or other documentation. 
  • Review of SOPs, master batch records, or any other documentation to assure successful manufacture of product. 
  • Review and approval of quality system records including change requests, deviations, and CAPA as necessary. 
  • Review and Disposition of finished goods or other manufactured product. 

Provide strategic direction to the QA Operations department to ensure that QA specific corporate objectives are met, including improving internal processes and practices. 

Ensure manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations (additional a plus). 

QA representation during site health authority inspections, and business forums including MRB and site leadership teams. 

Ensure QA staff training and development. 

This position will interact with other departments throughout the organization.  This position will partner with and influence Quality, Regulatory Affairs, Compliance, Technical Development, Finance, MSAT, and other departments as required.  This position requires constant contact with Senior Management across the organization. 

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, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. 



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.