Senior Manager QA Operations - External Quality

Profile

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. 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 DESCRIPTIONThe QA Operations Senior Manager is responsible for leading a team that provides quality oversight of all make, assess and release manufacturing related operations including batch review, deviations/CAPA oversight, batch release and preparation for QP certification. It is expected that the incumbent will lead QA Technical Managers/Associates/Specialists in a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. The position requires thorough knowledge and experience with EU & FDA GMP regulations as well as developed managerial, organizational, and project management skills. The QA Operations Senior Manager will build strong cross functional partnerships with Global External Operations and will have Quality to Quality relationships with Contract Manufacturing Organization (CMO) sites, to ensure effective communications and oversight of CMO operations. 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.RESPONSIBILITIESPeople Leader, with a team of ~10 people, in US and Ireland all working to make quality product for patients. The responsibilities in the role include the following:• Provide Quality expertise and leadership to the QA group with regard CMO Make, Assess, Release and CMO oversight.• Drive implementation of a science and risk-based Quality Culture throughout Global External Operations.• Lead the preparation and facilitation of CMO Oversight, CMO Quality meetings and CMO scorecards.• Review of SOPs, master batch records, or any other documentation to assure successful manufacture of product.• Oversee activities related to core operations including CMO Manufacturing Assessments, Deviations, Change Control sand CAPA systems.• Ensure QTA maintenance and compliance with CMO’s.• Participate in the Operations daily management meeting and coordinate all related cross-functional activities.• Lead, manage and develop a team of QA professionals.This position will interact with other departments throughout the organization. This position will partner with and influence within Quality (QP’s, Quality Process Managers), Operations, Regulatory Affairs, Compliance, Technical Development, Finance, MSAT, and other departments as required. 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. PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. 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.

Company info

BioMarin Pharmaceutical Inc.
Website : http://www.biomarin.com