Manager Distribution Quality/ Deputy Responsible Person

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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. Manager Distribution Quality/ Deputy Responsible Person - ShanballyClosing date 27th January 2023External Quality:This position will be the regional representative for the BioMarin External Quality function. The scope of the responsibilities are defined primarily within External Quality Good Distribution Practice (GDP). This position will also include building external and internal quality relationships with key business stakeholders. Work closely with internal and external functions to ensure GDP activities are addressed to support those functions. Performs a wide variety of GDP activities to ensure compliance with applicable regulatory requirements. Develops, implements, and maintains systems, programs and processes to ensure compliance with global GDP regulations. Safeguarding product users against potential hazards arising from poor distribution practices Ensure conditions of the relevant BioMarin distribution license requirements are met. Ensuring that continuous GDP training programmes are implemented and maintained. Providing guidance to BioMarin Marketing Authorization Holders (MAHs) on their responsibilities including New Product Introduction, QMS, QTA, Serialisation requirements.Educational Qualifications: BA/BS from an accredited University/College 5 years of experience with biotechnology, pharmaceuticals or human healthcare industries.Preferred Qualifications: Advanced Degree preferred. Lean and/or Six Sigma certification from a recognized certifying body or global organization engaged in Lean Six Sigma. RP AccreditedSpecific Skills: 5 years experience in pharmaceutical Compliance, Engineering, Manufacturing, or Quality functions. Excellent interpersonal and communications skills required. Strong organizational and technical writing skills required. Computer literacy required, including Microsoft PowerPoint, Word, Excel. Demonstrates strong technical and analytical skills; provides assistance to solving training/employee issues. Results oriented; effectively manages a multitude of projects efficiently. Demonstrates excellent negotiation skills; develops effective and supportive relationships with the departments supported. Experience managing internal and external project stakeholders. Excellent written and verbal skills; ability to communicate effectively with all levels of the organization. Builds relationships with other sites to promote training, shares best practices, and solves shared problems. Demonstrates in-depth understanding and application of GDP principles, concepts, practices and standards in the US and internationally. Demonstrates substantial knowledge of industry best practices and trends. Positive, solution focused outlook on daily challenges. 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.

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