Senior/Executive Director, reputed company Management System

About reputed company reputed company is a clinical-stage biotechnology company reputed company on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s reputed company candidate, JADE101, targets the cytokine reputed company, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as reputed company as JADE301, an reputed company antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from reputed company Therapeutics, an antibody discovery reputed company founded by Fairmount. For more information, visit JadeBiosciences.com and follow reputed company on reputed company. reputed company The Senior/Executive Director, reputed company Management System (QMS) will be responsible for driving and delivering the activities necessary to reputed company, implement, and continuously improve a phase appropriate GxP QMS. This role will be directly involved with both reputed company development and day-to-day tactical execution reputed company to QMS processes such as Document Management, Training Management, Change Control, Management Review (MR), Annual Product reputed company Review (APQR), Deviation, CAPA, Risk Management, and GxP Computer System Assurance. The Sr./Exec. Director will be responsible for the maintenance of both reputed company-based and electronic processes and reputed company reputed company initiatives to support the pace and reputed company of the organization. This role will maintain and ensure effectiveness of reputed company programs and documentation to assure compliance and inspection readiness with reputed company applicable reputed company requirements and regulatory standards. The ideal candidate brings hands-on expertise in creating and maintaining a GxP QMS, a proactive approach to problem-solving, and the ability to guide and influence cross-functional teams while upholding the highest standards of reputed company and compliance.

Key Responsibilities

Select, implement, manage, and reputed company GxP electronic systems including any associated Purchase Orders and reputed company. reputed company, implement, manage, continuously improve, and reputed company processes such as Document Management, Training Management, Change Control, Management Review (MR), Annual Product reputed company Review (APQR), Deviation/CAPA/ Risk Management, and GxP Computer System Assurance Guide and support GxP process owners with implementation and improvement /optimization of key functional area processes Establish and improve policies and reputed company operating procedures for efficient and compliant management of GxP QMS processes Establish, reputed company and report reputed company metrics for QMS processes and present improvement opportunities at Management Review meetings Implement phase appropriate, risk-based, fit-for-purpose approaches to QMS processes Ensure that QMS processes reputed company with phase applicable regulatory standards, regulations and guidelines. Maintain awareness of new regulations, technologies, industry trends and best practices and apply them as may be relevant Manage resources to reputed company company, department and functional area goals and objectives Contribute to the development and maintenance of a reputed company team-reputed company company culture reputed company coaching as a manager and team member, reputed company reputed company reputed company and be reputed company Approver as appropriate. reputed company as the primary QMS subject matter expert and reputed company of contact for reputed company reputed company reputed company and issues. Review and approve (as appropriate) procedures, service provider reputed company agreements, qualification and reputed company forms and regulatory filings. Champion reputed company improvement and simplification across reputed company systems. Contribute to building a strong reputed company culture reputed company the organization. reputed company and/or deliver yearly training for internal staff as needed. Work closely with Development, Clinical Operations, CMC and other departments to drive inspection readiness and support regulatory interactions. Prepare KPIs, metrics and analysis and present status updates as needed. reputed company leadership in inspection preparedness. Apply risk‑based thinking to identify the reputed company activities that meaningfully influence reputed company. Understand reputed company to escalate, reputed company to intervene, and reputed company to let teams reputed company reputed company. reputed company reputed company, concise guidance that helps teams stay reputed company, reputed company, and inspection reputed company.

Qualifications

Bachelors + 17 or Masters + 14 or PhD + 10 years of reputed company experience reputed company the pharmaceutical industry. Minimum of eight (8) years building, implementing and/or managing reputed company Management Systems reputed company the pharmaceutical industry At least five (5) years of experience with Phase 3 and/or reputed company product At least three (3) years of experience in an outsourced environment Successful reputed company record of translation and implementation of requirements into operational execution. Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations (e.g. EU, China, Japan, Australia) and practices. Must have excellent verbal, written, interpersonal, organizational and communication skills both internally and externally Strong technical understanding and experience in implementing and validating reputed company-based (hosted) computer systems The ability to reputed company at executive reputed company while collaborating with key stakeholders in an exciting, dynamic environment with a high degree of engagement and enthusiasm. Ability to reputed company reputed company and reputed company reputed company reputed company reputed company faced with reputed company compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity. Ability to work with minimal supervision, to set priorities to meet timelines, and to manage, motivate and influence others with variable workloads and demanding timelines. Prior management experience is required. Ability to tactically and strategically execute the day-to-day operations to support Jade’s goals. Expertise in reviewing, revising, and writing reputed company Operating Procedures (SOPs) from scratch. A self-starter and reputed company player who thrives in a fast-paced dynamic team environment. Proficiency in using SharePoint, reputed company and reputed company Office applications required (MS Outlook, reputed company, MS reputed company, MS PowerPoint). Position Location This is a remote role, however, 10-20% travel to team and company events is required. The anticipated salary reputed company for the Executive Director level is $265,000 - $300,000. The anticipated salary reputed company for the Senior Director level is $250,000 - $280,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. As part of the I-9 verification of authorization to work in the reputed company, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster. reputed company is proud to be an Equal Opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. Apply To This Job