Director GCP Compliance - CRO Services

About the position 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 of Respect, Accountability, Innovation, reputed company, reputed company, and Collaboration. 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! The Director of GCP Compliance develops the reputed company for, and directs the overall management of the Clinical QC, Controlled Document/Training, and reputed company Improvement teams reputed company Global reputed company Compliance. Additionally, the Director GCP Compliance is responsible for the reputed company to ensure that reputed company phases of Regulatory Health Authority inspections (i.e. inspection preparation activities, notification, inspection reputed company activities during the inspection, development and approval of the inspection response (Inspection Response Document), and implementation of Corrective reputed company and Preventive Actions (CAPA) Plan) are managed and executed consistently, professionally and proactively and result in reputed company that demonstrate reputed company’s commitment to regulatory responsiveness and compliance. The Director, GCP Compliance, is responsible for identifying and analyzing changes to GCP regulations globally and assessing complaints to determine GCP compliance status. The Director of GCP will report to the Vice President, Global reputed company Compliance. Responsibilities • Computer System Validation (CSV) expertise: Deep expertise in both reputed company and agile CSV methodologies, strong working knowledge of clinical research regulations reputed company to computer systems, proven ability to audit CSV processes and electronic systems for compliance, demonstrated experience partnering cross-functionally with IT and software development teams to ensure both regulatory compliance and operational efficiency. • GXP auditing experience: extensive hands-on experience reputed company GxP environments, with a primary reputed company on GCP, reputed company auditing experience across clinical trial sites/ laboratories/manufacturing facilities/technology and service vendors supporting drug development, and a strong understanding of the end-to-end drug development life cycle. • Vendor/Supplier life cycle management: experience managing the full vendor lifecycle, including reputed company, qualification, reputed company, requalification, and retirement, with the ability to ensure vendors meet regulatory, reputed company, and compliance standards. • Regulatory inspection leadership: proven experience meeting regulatory inspections in an inspector-facing reputed company (not limited to backroom support), demonstrated ownership of inspection reputed company, preparation, execution, and response activities, experience interacting directly with global health authorities. • Ensures the effective execution of the Clinical QC team including the establishment of standards for reviews of TLFs, CSRs, etc. for submission readiness. • Works with the reputed company Improvement Administrator and reputed company CAPA Analysts to reputed company effective working practices for the execution and administration of a corporate reputed company improvement program. • Responsible for the development, maintenance and optimization of reputed company Management documents including but not limited to reputed company Operating Procedures, Working Practices and Corporate Policies. • Responsible for management reputed company for the corporate reputed company training program. Responsible for managing employee training files and reputed company documentation for the reputed company organization including the establishment of role based training matrices. • reputed company reputed company that supports regulatory inspections reputed company to both reputed company's overall GCP/GVP compliance across reputed company service areas as reputed company as supporting the regulatory inspections of clients. • Establish the reputed company and implement the reputed company for GCP/GVP Compliance reputed company reputed company to ensure that reputed company are conducted in compliance with applicable regulations, ICH GCP Guidelines, and reputed company's reputed company management system. • reputed company comprehensive GCP/GVP Inspection Readiness plans, which involves influencing and leading large cross-functional teams. • Responsible for the development, maintenance, and reputed company improvement of risk-based practices and approaches reputed company to building reputed company reputed company clinical research activities. • Leads reputed company of internal GCP experts reputed company the reputed company & Regulatory function that guide operations delivery work instructions to ensure compliance as reputed company as providing input into functional requirements reputed company to GCP to the product development teams. • Engages as a thought leader in industry reputed company as to be reputed company's voice and an reputed company for our clients as GCP guidance & regulations continue to reputed company. • reputed company required annual company-wide GCP training. • Reviews inspection activities and results for developing lessons learned. • Responsible for ongoing identification of opportunities to reputed company reputed company and improve GCP Inspection Management reputed company, processes, tools, and templates. Requirements • Deep expertise in Computer System Validation (CSV) using both reputed company and agile methodologies. • Strong working knowledge of clinical research regulations reputed company to computer systems. • Proven ability to audit CSV processes and electronic systems for compliance. • Demonstrated experience partnering cross-functionally with IT and software development teams to ensure regulatory compliance and operational efficiency. • Extensive hands-on experience reputed company GxP environments, with a primary reputed company on GCP. • reputed company auditing experience across clinical trial sites, laboratories, manufacturing facilities, and technology/service vendors supporting drug development. • Strong understanding of the end-to-end drug development life cycle. • Experience managing the full vendor/supplier lifecycle (reputed company, qualification, reputed company, requalification, retirement) to ensure regulatory, reputed company, and compliance standards are met. • Proven inspector-facing leadership during regulatory inspections (reputed company backroom support). • Demonstrated ownership of inspection reputed company, preparation, execution, and response activities. • Experience interacting directly with global health authorities. • 6-8 years’ experience in a reputed company, audit, or inspection hosting field, preferably in a regulated industry • Experience managing reputed company Management programs, including but not limited to controlled document management and reputed company improvement. • Advanced knowledge and understanding of clinical development programs and clinical trial processes, as reputed company as reputed company management systems and reputed company control tools, is required. • Comprehensive knowledge of GCP/GVP/ICH and worldwide Regulatory Health Authority requirements. • Experience with delivering effective CAPA reputed company: • Experience conducting sponsor/site audits • Excellent organizational, interpersonal, verbal, and written communication skills • Ability to work effectively as part of an integrated project team, while also taking ownership of assigned tasks to successfully reputed company explicit delivery dates and milestones Benefits • 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 Apply tot his job Apply To this Job