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 This position reports to the Director, Engineering Quality in Quality Sciences and Technology (QSAT) group and is responsible for setting the global Quality requirements and standards for each phase of the Device, Combination Product and Packaging Lifecycle.\u00A0 \u00A0This position partners with Technical Operations technical organizations such as MSAT, Technical Development, QSAT, Regulatory Affairs and Quality. This role will provide quality oversight for design control and risk management activities for combination products and medical devices.\u00A0 This individual will work closely with the Associate Director of Devices in QSAT as well as the device development teams, medical device suppliers and testing partners during the device design/development phases with supportive responsibilities throughout the device lifecycle. The incumbent will provide technical support in drug product packaging related activities and drug product process transfers.In addition, this role will provide oversight for the development, implementation, and continuous improvement of device, combination product and finished product packaging related quality processes and procedures and ensure compliance to the relevant standards and regulatory requirements.\u00A0 The finished product packaging consists of primary and secondary components and configurations suitable for patient use.\u00A0 In this role the candidate is expected have demonstrated technical and quality in device and combination products as well as understanding and interpreting device and combination product regulations and standards. \u00A0RESPONSIBILITIES: Lead Quality Engineering guidance and oversight for combination products and medical device during feasibility, all phases of design control, risk management, human factor/usability engineering, process development and verification/validation testing, as well as lifecycle management during design changes.Lead Quality review and approval of all technical documentation for design and development technical and risk management documentation, e.g., planning, design inputs/outputs, verification, traceability matrix, protocols, reports, risk assessments, testing, etc. through applying applicable company procedures and regulatory requirements.Provide input to process manufacturing design and design transfer to ensure compliant, robust product realization.Support teams and strategy for filing through authoring and/or reviewing sections of filing applicable to design control, risk management and specification and supporting responses to regulatory questions.Lead or support sustainable, continuous improvement to the device and combination product Quality Management System and best practices for device lifecycle processes by identifying areas for improvement and engaging in remediation.\u00A0This includes the implementation of new components of our quality management system & process to support our expanding portfolio. Function as the Quality representative on cross-function initiatives and device development programs.As the Quality partner to Process Development, collaborate to establish and sustain the DP/Packaging/Device/FG process business processes that incorporate industry best practices and are health authority compliant to conduct the development, validation, licensing, and commercialization of BioMarin\u2019s drug and combination products.\u00A0 Thorough partnering with Global MSAT, share knowledge gained through process performance trend analyses to increase the collective understanding of the validated process and feedback to Process Sciences for future programs.In partnership with TOPS Training, develop, and provide DP/Packaging/Combo-Products manufacturing system operations educational content and selected instructor led trainings.Serve in the Quality Partner Team (QPT) to support quality own CMC deliverables in the areas of device/combination products and packaging for at all product lifecycles Interact with and have ability to influence decisions of Device Design, Development, GSC, Manufacturing, Engineering, CMO Directors and Vice Presidents. Requires high level of competence, confidence, and credibility. Establish effective partnership with the following groups: MSAT including packaging development Technical Development Manufacturing Quality- Site quality, Global QA and all other QSAT functions Regulatory Interact with and have ability to influence decisions of R&D, PD, GSC, Manufacturing, Engineering, Supply Chain, QA/QC and CMO Directors and Vice Presidents. Requires a high level of competence, confidence, and credibility. Lead projects as assigned EXPERIENCE Minimum of 8 years of experience in medical device and/or combination product function within a medical device, biotech, or pharmaceutical company Experience in device and combination products is required.Experience in medical device design and development technical oversight and related risk assessment and management throughout the product lifecyclePrior 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.Working knowledge and application of device regulations, including 21 CFR 820, 2017/745 MDR, 21 CFR 21 Part 4, ISO 13485, ISO 14971, and ICH Q9, ISO 11608, ISO 62366, ISO 10993. \u00A0ISO 62304 is a plus.Working knowledge of process development and validation principlesExperience in hazard analysis and application of risk analysis tools such as FMEA, Fishbone, etc.Experience in Change Control and CAPA applicationsUnderstanding and experience with change control and Health Authority requirements highly desirable. Strong collaboration skills and demonstrated ability to lead change and identify opportunities that have resulted in positive business outcomesDemonstrated organizational agility that demonstrates how to get results while strengthening internal and external relationships.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-functionallyAbility to work effectively with stakeholders in various countries/regionsDemonstrated ability to partner with other functional groups to achieve business objectivesResults oriented; effectively manages multiple projects efficientlyExcellent written and verbal skills; ability to communicate effectively with all levels of the organization; effective public speakerBuilds strong, effective working teams; builds relationships to share best practices, and collaboratively solve problemsIn-depth understanding and application of cGMP principles, concepts, practices, and standardsPrior 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.\u00A0EDUCATION A minimum of B.S. degree in a technical discipline (physical, engineering, chemical or biological sciences) is required. OTHER: Ability to travel up to 30% \u00A0 SUPERVISOR RESPONSIBILITY:\u00A0Position is an individual contributor and has no direct reports. 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.
