Job 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 \u2013 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\u2019s 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\u2019s 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\u2019 lives.SUMMARY DESCRIPTION (Technical Manager, QA Operations Novato)The QA Operations Manager is responsible for providing quality oversight of \u201CMake/Assess/Release\u201D activities \u00A0related to Novato operations including document review/approval, deviations/CAPA review and approval and facility oversight. It is expected that the candidate will operate 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 FDA GMP and EU regulations as well as developed managerial, organizational, and project management skills. The QA Operations Manager will build strong cross functional partnerships with Novato Operations groups to ensure effective communications and oversight of Novato operations.RESPONSIBILITIES Quality oversight of Material Operations within the Novato Warehouses (21 Pimentel and 79 Digital) including Weighing/Kitting operations. This position will also have quality oversight of the facilities associated with the Novato Warehouses (21 Pimentel and 79 Digital) including the Weighing/Kitting area(s). Providing quality oversight of deviations, CRs and Veeva workflows for Material Operations and Weighing/Kitting operations. Quality oversight for issues impacting warehouse operations. Performing Self Inspections for the Warehouse areas in support of Inspection Readiness efforts. Inspection support during area tours for regulatory audits. Training and coaching personnel within area of responsibility on deviations, CRs and Veeva workflows. Strategizing with area owners regarding QMS records to ensure timely approvals and appropriate resources are available for record execution.SKILLS Understanding and familiarity with\u00A0cGxPs, Health Authority Regulations, Quality\u00A0Systems,\u00A0and technical\u00A0expertise\u00A0in Make/Assess/Release operations and processes. Effective communication skills\u00A0 Proven organizational skills to coordinate cross functional\u00A0support for compliance issues.\u00A0\u00A0 Ability to speak, present data, and defend approaches in front of audiences and inspectors.\u00A0 Ability to\u00A0comprehend\u00A0technical information related to equipment, facilities, processes, and regulatory expectations.\u00A0 Experience participating in regulatory inspections. Presenting/defending differing subjects in audits or regulatory inspections.\u00A0 Understanding and familiarity with\u00A0FDA, European and international regulatory requirements, guidelines, and recommendations for quality systems. Experience in report/technical\u00A0writing with proficient organizational, spelling, grammar, and typing skills\u00A0required.EDUCATION\u00A0BA\u00A0or\u00A0BS\u00A0degree (physical or biological science preferred but not\u00A0required). Equivalent experience may be considered.\u00A0EXPERIENCE5 \u00A0years\u2019 experience\u00A0in pharmaceutical or related industry, with demonstrated knowledge or\u00A0proficiency\u00A0working within Quality Systems.\u00A0MANAGER RESPONSIBILITY\u00A0Individual contributor.\u00A0PLEASE 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.\u00A0
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