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Director, Regulatory Compliance
Location:
Boston, MA
Description:
Director, Regulatory Compliance page is loaded Director, Regulatory Compliance Apply locations Boston, MA time type Full time posted on Posted 3 Days Ago job requisition id REQ-21257 Job DescriptionGeneral Summary:The Director, Regulatory Compliance is responsible for ensuring that Global Regulatory Affairs (GRA) adheres to Vertex's compliance framework, and that GRA requirements are embedded within the Quality Framework. This role provides compliance oversight, guidance, and direction to all GRA relevant functions, key stakeholders and leadership teams. This role investigates departmental deviations, and oversees internal compliance reporting, metrics and prioritization of risk based deliverables.Key Duties and Responsibilities: Provides compliance oversight, guidance and direction to all relevant employees, key stakeholders and leadership teams in GRA Partners with cross-functional teams to collaborate, negotiate and drive fact- and risk-based decision making Supports the Quality System as pertains to GRA, and its applicable subsystems as assigned; oversees quality systems and compliance Leads deviation reporting, investigation, and development and closure of corrective actions and effectiveness checks Acts as the GRA Lead for regulatory agency, third-party and internal inspections. Oversees documentation requests and interactions between GRA and internal Quality groups, addresses findings and adheres to health authority response timelines Prioritizes and oversees any remedial measures as a result of a CAPA or other identified compliance issues Serves as the regulatory compliance representative on various cross-functional teams to identify and assess risks and develop solutions to mitigate risk Oversees the development of key quality metrics related to Regulatory Compliance, tracks and reports out these metrics to RALT Collaborates with GRA stakeholders to ensure compliance with policies and regulatory requirements As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.Knowledge and Skills: Advanced and contemporary knowledge and expertise in interpretation of regulations, guidelines, and precedents related to Quality Management Systems and global regulatory and development activities Demonstrated experience in a regulatory compliance role Results oriented; problem solving capabilities Exhibits strong organizational and project management skills necessary to perform complex tasks independently and work on multiple projects simultaneously Strong interpersonal and communication skills, and the ability to effectively influence others internally/externally including colleagues at all levels of the company, including but not limited to GRA, Manufacturing, Clinical, Quality Assurance, Legal, and Information Technology Experience with Health Authority inspections/audits and the development and implementation of compliance corrective action plansEducation and Experience: Bachelor's degree in a scientific or allied health field Typically requires 10 years of experience in relevant regulatory compliance work or the equivalent combination of education and experienceWe're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can -choose to work:1. -Hybrid -and work remotely up to two days per week; -or select2. -On-Site and -work 5 days per week with ad hoc flexibility. #LI-EE1 #LI-HybridCompany Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at XXXX@vrtx.com. Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases - cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia - and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com -or follow us on Facebook , Twitter/X , - LinkedIn , - YouTube -and - Instagram . The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives. -Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work. #J-18808-Ljbffr
Company:
Vertex Pharmaceuticals
Posted:
March 18 on TopUSAJobs
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More About this Listing: Director, Regulatory Compliance
Director, Regulatory Compliance is a Executive Director Job at Vertex Pharmaceuticals located in Boston MA. Find other listings like Director, Regulatory Compliance by searching Oodle for Executive Director Jobs.
Director, Regulatory Compliance is a Executive Director Job at Vertex Pharmaceuticals located in Boston MA. Find other listings like Director, Regulatory Compliance by searching Oodle for Executive Director Jobs.