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 The Engineering Quality (EQ) Director reports to the Executive Director, Quality Science and Technology (QSAT) and is accountable for building and leading a high performing team comprised of process and system based technical experts in Device, Combination Product, Packaging, Drug Substance and Assets.\u00A0 This role is instrumental in maturing BioMarin\u2019s device and combination product life-cycle management within Quality as well as in collaboration with MSAT, Technical Development and Regulatory. The incumbent will be responsible to establish strategic partnership with stakeholders within and outside of Technical Operations (TOPs) to implement technical process support models, identify synergies and efficiencies as well as define/enhance roles and responsibilities. The position is also responsible for mentoring and developing the EQ team and handle cost center duties related to budget.In this role the candidate is expected to show and have advanced knowledge and experience in the following competencies: Decision Making, Strategic Thinking, Problem Solving, and Metrics Reporting Influence and Collaboration Agility and Proactivity Leadership and People ManagementDemonstrated technical and quality experience, at minimum, in the following areas: Device and combination products Drug development or manufacturing Understanding and interpretation of device & combination products regulations and standards.\u00A0Key responsibilities include but are not limited to:Lead and develop a high performing team with strong technical leadership capabilities that can navigate and lead in a matrix organization and to provide guidance and quality oversight for device and combination products & device product lifecycle from development through commercialization to our quality & cross functional partners. Develop and maintain science and risk-based business processes that incorporates health authority requirements or expectations in support of BioMarin product portfolio throughout the product life cycle including development, validation, and commercialization. \u00A0Assure integration of asset, device, drug, method, and biologic regulations into the business process system.Understand and interpret regulatory requirements and standards such as 21 CFR, EudraLex and ISO. Provide guidance to senior management, quality partners and project teams on the interpretations as necessary.Develop and implement programs for building and/or enhancing technical expertise and critical thinking skills in Quality. Establish and maintain effective partnerships with key cross-functional stakeholders including, but not limited to, the following:Quality \u2013 Site, Global and across QSAT functionsMSATTechnical DevelopmentRegulatoryManufacturingSupply ChainEnsure the development and maintenance of EQ owned technical standards and policies.Represent QSAT with engineering & science lifecycle improvement initiatives.\u00A0 Maintain current knowledge of industry standards. Interacts with senior internal personnel and external partners on significant matters often requiring coordination across functions and facility locations.Interact with and have ability to influence decisions of across organizations at all levels of management. Requires high level of competence, confidence, credibility, and clear/concise communication skill.Serve as a strategic technical partner for developing strategic plans that will deliver efficient and synergistic opportunities, projects, and systems within and outside of TOPs. Establish and maintain capacity model & performance metrics for EQ and provide routine reporting. Maintain and manage cost center budget Lead initiatives and projects as necessary\u00A0EXPERIENCE 12 years of experience in medical device and/or combination product function within a medical device, biotech, or pharmaceutical company 5 years of prior management level experience with demonstrated ability to develop and mentor staff Strong collaboration skills and demonstrated ability to lead change and identify opportunities that have resulted in positive business outcomes Demonstrated organizational agility that demonstrates how to get results while strengthening internal and external relationships with minimal resources. Understanding of FDA, ISO and EU regulations related to device and combination product is required. Consistent demonstration of managerial courage to make timely decisions without complete data to ensure quality product to patients. Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization. Ability to influence diverse stakeholder and drive accountability and decision-making cross-functionally Ability to work effectively with stakeholders in various countries/regions Demonstrated ability to partner with other functional groups to achieve business objectives Results oriented; effectively manages multiple projects efficiently Excellent written and verbal skills; ability to communicate effectively with all levels of the organization; effective public speaker Builds strong, effective working teams; builds relationships to share best practices, and collaboratively solve problems In-depth understanding and application of cGMP principles, concepts, practices, and standards Prior experience with Regulatory, Quality, or a combination of technical experience such as technical development/manufacturing sciences and Quality/Regulatory in Device or Combination Product areas preferred. Ability to comprehend scientific/technical information related to equipment, processes, and regulatory expectations. Health Authority regulatory submissions and inspection experience is a plus but not required.\u00A0EDUCATIONB.S. degree (MS/PhD preferred) in a technical discipline (physical, engineering, chemical or biological sciences) is required. OTHER Ability to travel up to 30% \u00A0PLEASE NOTE:\u00A0Absent 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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