Manager Clinical Quality Operations

Profile

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 CultureOur 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.BioMarinu2019s 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 BioMarinu2019s 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 patientsu2019 lives. Provide quality oversight of CDMO operations related to the manufacture and testing of products for use in GLP early phase GMP studies (toxicity studies through Phase 2). This role may include oversight activities related to internal early phase programs as needed. u2022 Drafting and review of quality agreements with CDMOs and CTOs as required. u2022 Auditing CDMOs to determine suitability to perform necessary operations to BioMarinu2019s quality standards. u2022 Review of GMP documentation from CDMOs and CTOs per a phase appropriate approach, including changes, deviations, batch records and test records.u2022 Support Implementation of a risk based CDMO oversight program through drafting and review of necessary SOPs, change records, and other supporting documentation. u2022 Performing batch release of BioMarin products and intermediates manufactured and CDMOs. Core Competencies Collaborative Leadership- Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment.u00A0High tolerance for ambiguity and able to create order from chaos.u00A0Builds credibility through solid relationships and solid track record of results. Ownership and Accountabilityu2013 Takes accountability for actions, drives results, and able to learn from mistakes. Delivers on promises, goals, and expectations. Makes quality decisions and resolves problems with minimal delay as appropriate. Asks u201Cwhat can I do to help?u201D Communication- Ability to communicate effectively up and down, at all levels of the organization, present complex and/or new ideas with clarity and simplicity.u00A0Ability to draft and deliver clear and concise procedures or business process documents. Planning - Excellent planning and prioritization skills with the ability to multitask and adapt.u00A0Able to synthesize large amounts of information.u00A0Able to deliver results despite shifting environment. Analytical Problem Solvingu2013 Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes.u00A0Innovative and effective in solution development, risk mitigation, and execution. Customer focus - Partners with customers, looks ahead to predict future customer needs. Manages expectations.Required Skills Minimumu00A04u00A0years of experience in a Quality/Compliance/Regulatory setting Sound knowledge of cGMPs and equivalent industry regulations Prior experience with technical oversight of Deviations and CAPAs Proficiency with computer systems u2013 Microsoft Office Suite Proficiency with database use for example Veeva or other QMS, Benchling or other ELN, LIMS, Oracle or other ERP preferred 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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