Associate Director\/Sr. Manager, Product Quality Leader
Novato, CA
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. Role OverviewThis individual will serve as a technical quality expert for one or more products during clinical development all the way through post-commercialization.\u00A0 The role is responsible for making technical quality-related decisions and serving as the single point of contact on the CMC (Chemistry, Manufacturing and Controls) team for all quality functions, risks and issues associated with the assigned products. As a core member of the CMC team, the PQL provides efficient and effective quality leadership of CMC-related strategic activities and drives associated quality decisions.Key Responsibilities As the single point of contact within a CMC Team for all product quality topics, participate fully in CMC team meetings, and other relevant technical forums, providing technical quality expertise to influence global strategies and ensure robust implementation plans for product/program changes for all stages of the product life cycle (Pre-IND through post-Launch lifecycle management) Partner with CMC Team and the Quality organization to identify, develop and prioritize long-term product strategies/initiatives enabling the clinical to commercial transition, new product introductions and tech transfers; accountable for creation of the product-specific Quality strategy Lead the cross-functional Quality Partner Team (QPT) supporting Quality-related CMC deliverables; accountable for managing the QPT deliverables in alignment with CMC execution plans, including timelines and scope. Responsible for timely and clear communication of all relevant information to and from the QPT to the CMC Team and functional managers Own and manage the product quality risk register to ensure identification, resolution, mitigation and/or escalation of product quality issues and risks to CMC team and/or Senior Management Responsible for developing a phase appropriate product specification as part of product control strategy creation; collaborate with CMC Lead to establish a phase appropriate Quality Target Product Profile (QTPP) and ensure the right quality characteristics are implemented during product development. Lead efforts to develop product comparability assessments for commercial products, including sample selection and acceptance criteria identification needed to support process/site changes Interpret and apply applicable regulatory guidelines and directives (e.g., 21CFR, USP, EP. JP, and ICH) to product quality, staying abreast of changes and advising stakeholders appropriately Review and author regulatory submissions sections and provide input to ensure clarity and consistency of messaging across Quality owned sections Provide oversight and monitor CMC related Health Authority commitments and ensure timely completion. Provide routine updates and visibility of submission commitments to functional and senior management Support, or lead, efforts to identify, define, and mobilize initiatives to improve the efficiency and effectiveness of PQL operational processes Identify and lead cross portfolio initiatives or improvements that will reduce overall technical quality risks for the product portfolio, as required\u00A0Experience/EducationBA/BS in life sciences or related field required. Advanced degree desirable.12 years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industryExcellent interpersonal and communications skillExperience with influencing diverse stakeholders and driving accountability and decision-making in a highly matrixed, cross-functional environmentHighly capable of building strong, effective working teams; experience with developing relationships focused on best-practice sharing and collaborative problem solvingSkilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organizationResults oriented; effectively manages multiple projects efficientlyExcellent written and verbal skills; ability to communicate effectively with all levels of the organization; effective public speakerIn-depth understanding and application of cGMP principles, concepts, practices and standards; understanding of the international regulatory landscape preferredBroad range of knowledge and experience in Quality with biologic and chemical processes, drug development, analytical methodsPrior experience with Regulatory, Quality, Compliance or a combination of technical experience such as analytical development, manufacturing sciences and Quality/Regulatory\u00A0Other: Ability to travel up to 30% 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.
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