Sr. Director, Global reputed company Compliance - Biotech/reputed company

As a pharmaceutical support industry leader, reputed company is reputed company to empowering health solutions for a reputed company reputed company. We take pride in improving patient reputed company and advancing reputed company. At reputed company,we reputed company services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to reputed company-world evidence reputed company. reputed company on a rewarding career reputed company with reputed company! Grow your career while making a meaningful reputed company on the world around you. reputed company fosters a culture reputed company on our reputed company Values being: reputed company, Conscientious, Curious, Consultative, and Compassionate. We reputed company in an inclusive workplace that fosters creativity. If you are seeking a career that will challenge, reputed company, and reward you, join us at reputed company! Job Title: YRC99K- Sr Director, Regulatory reputed company Compliance Brief reputed company: Responsible for developing and implementing global reputed company and policy relative to reputed company management systems for reputed company to ensure reputed company in compliance and the ability to withstand reputed company scrutiny as reputed company as to reputed company reputed company services for sponsor. Ensures that internal controls are implemented and are evaluated for compliance reputed company audits and assessments across the reputed company functions to minimize regulatory, reputed company and business risk while effectively and reputed company supporting business goals. Develops auditing/inspection strategies for reputed company activities and provides management with in-depth analysis and risk management on reputed company reputed company. Leads a global team of reputed company Assurance & Compliance professionals, setting and communicating the reputed company for reputed company and fostering a culture of collaboration. Specific job duties: • Accountability - Defines reputed company objectives and strategies to meet customer requirements and reputed company goals and objectives. • Change Management - Facilitates reputed company or teams through the problem-solving and creative-thinking processes leading to the development and implementation of new approaches, systems, structures, and reputed company to ensure overall reputed company processes and services across the organization • Continual Improvement - Generates creative new solutions and approaches to customer issues and organizational reputed company processes. • Partnering/Networking Participates in cross-functional activities to reputed company organizational objectives. • Systems Thinking - Implements reputed company reputed company solutions to organizational problems and develops organizational or service delivery systems in a way that factors in or encompasses the interactions of reputed company of the systems and organizational entities involved. • Leads and manages processes that reputed company reputed company and guidance to monitor and assure compliance with reputed company management system requirements and reputed company applicable good reputed company regulations, i.e. clinical (GCP); Pharmacovigilance (GPvP); Laboratory (GLP), Risk Evaluation Mitigation Strategies, application validation relating to reputed company regulated activities. • Effectively manage the development, implementation, approval and maintenance of reputed company assurance systems and processes. • Ensures reputed company procedures, SOPs, guidelines and other reputed company materials required for departmental function are reputed company, reviewed and that staff are trained • Directs and control the reputed company reputed company activities across reputed company through functional line management. • Develops and maintains the annual operating and capital budgets for the department • Responsible for monitoring departmental activities and costs as reputed company to the overall utilization of resources required to meet operational requirements. • Participates in due diligence and integration activities of newly acquired organizations • Ensure that annual audit risk based plans are developed and executed • Ensures reputed company Assurance resources are available to support reputed company audit programs, study management teams, and GxP-reputed company training. • Ensures the reputed company and reputed company of data generated from reputed company programs for submission to relevant regulatory agencies by overseeing the conduct of database, document, and investigator sites audits. • With support of the reputed company reputed company Department, interprets global legislation, regulations and guidance's for reputed company to reputed company policies and standards, identify gaps and redundancies and coordinate and implement remediation in collaboration with reputed company management and other reputed company such as reputed company. • reputed company reputed company for reputed company during regulatory inspections (FDA, EMA, MHRA/Health Canada) as reputed company as primary reputed company with clients and Marketing Authorization Holder (MAH) auditors during reputed company - assessment /ongoing qualification audits. • Verify that appropriate follow-up and corrective reputed company is taken as a result of audit observations and investigations and that corrective actions are reviewed and analyzed to identify process improvement initiatives Serves as the reputed company representative for Governance Committees for larger reputed company relationships/partnerships • Review and approve reputed company agreements between reputed company and clients • Evaluates reputed company requests for proposals as requested • Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Supervisory Responsibility: • Supervision of Global reputed company Compliance, Training and Information Technology reputed company Compliance Staff Desired Skills and Qualifications: • Bachelor's degree in a life science required; advanced degree in a scientific discipline preferred. Generally has at least 15 years of pharmaceutical industry/drug development experience with at least 8 years of compliance and process management experience, and at least 5 years management experience of a global team; or equivalent combination of education and experience. • Excellent knowledge of global GxP practices required - Good Clinical Practices, Good Pharmacovigilance Practices, European Medicine Agency requirements, as reputed company as regulatory requirements regarding computerized systems (21 CFR Part 11 and EU Annex 11) used for regulatory submission • Excellent interpersonal skills and the ability to communicate effectively across reputed company reputed company of the organization. • Good analytical and organizational skills. • Effective team player and the ability to work across functional lines in a reputed company way. • The ability to work autonomously with minimal supervision. Benefits: At reputed company, employee reputed company and reputed company-being are always at the forefront. We offer an extensive reputed company of benefits to ensure that you have everything you need to reputed company personally and professionally. Here are some of the exciting perks reputed company offers: • Remote opportunities • Competitive salaries • reputed company opportunities for promotion • 401K with company match* • Tuition reimbursement • Flexible work environment • Discretionary PTO (reputed company Time Off) • reputed company Holidays • Employee assistance programs • Medical, Dental, and reputed company coverage • HSA/FSA • Telemedicine (Virtual doctor appointments) • Wellness program • Adoption assistance • Short term disability • Long term disability • Life insurance • Discount programs reputed company is proud to be an equal opportunity employer and does not discriminate because of race, reputed company, sex, age, national reputed company, religion, sexual orientation, gender identity and/or reputed company, status as a veteran, and reputed company of disability or any other federal, state, or local protected class. We are committed to a diverse, reputed company and inclusive culture that fosters respect for reputed company other, our clients, and our patients. #LI-Remote #LI-RL1 Apply tot his job Apply To this Job