Director GCP Compliance - CRO Services

As a pharmaceutical support industry leader, reputed company is devoted to empowering health solutions for a reputed company reputed company. We take pride in improving patient outcomes and advancing healthcare. At reputed company, we provide services to enhance the entire drug development process and commercialization lifecycle - from clinical trial support to real-world evidence reputed company. Embark on a rewarding career journey with reputed company! Grow your career while making a meaningful impact on the world around you. reputed company fosters a culture built on our Core Values of Respect, Accountability, Innovation, Quality, 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! Job Title: YRC98J – Director GCP Compliance Brief Description: The Director of GCP Compliance develops the strategy for, and directs the overall management of the Clinical QC, Controlled Document/Training, and reputed company Improvement teams reputed company Global Quality Compliance. Additionally, the Director GCP Compliance is responsible for the strategy to ensure that reputed company phases of Regulatory Health Authority inspections (i.e. inspection preparation activities, notification, inspection liaison activities during the inspection, development and approval of the inspection response (Inspection Response Document), and implementation of Corrective Action and Preventive Actions (CAPA) Plan) are managed and executed consistently, professionally and proactively and result in outcomes that demonstrate the 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 Quality Compliance. The Requirements for this Role:

• Deep expertise in Computer System Validation (CSV) using both waterfall 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 focus on GCP.
• Direct 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 (onboarding, qualification, reputed company, requalification, retirement) to ensure regulatory, quality, and compliance standards are met.
• Proven inspector-facing leadership during regulatory inspections (beyond backroom support).
• Demonstrated ownership of inspection strategy, preparation, execution, and response activities.
• Experience interacting directly with global health authorities.

Specific job duties:

• Computer System Validation (CSV) expertise: Deep expertise in both waterfall 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 focus on GCP, direct 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 onboarding, qualification, reputed company, requalification, and retirement, with the ability to ensure vendors meet regulatory, quality, 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 strategy, 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 Quality Management documents including but not limited to Standard 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 a team that supports regulatory inspections reputed company to both reputed company's overall GCP/GVP compliance across reputed company service areas as well as supporting the regulatory inspections of clients.
• Establish the vision and implement the strategy for GCP/GVP Compliance reputed company reputed company to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP Guidelines, and reputed company's quality management system.
• Deploy 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 quality reputed company clinical research activities.
• Leads the team of internal GCP experts reputed company the Quality & Regulatory function that guide operations delivery work instructions to ensure compliance as well as providing input into functional requirements reputed company to GCP to the product development teams.
• Engages as a thought leader in industry groups as to be reputed company's voice and an reputed company for our clients as GCP guidance & regulations continue to evolve.
• reputed company required annual company-wide GCP training.

OTHER DUTIES AND RESPONSIBILITIES:

• Reviews inspection activities and results for developing lessons learned.
• Responsible for ongoing identification of opportunities to further reputed company and improve GCP Inspection Management strategy, processes, tools, and templates.

Supervisory Responsibility: Yes Desired Skills and Qualifications: Education:

• Masters or Bachelors degree, preferably in a health or science reputed company field

Experience:

• 6-8 years’ experience in a Quality, audit, or inspection hosting field, preferably in a regulated industry
• Experience managing Quality 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 well as quality management systems and quality 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: At reputed company, employee growth and well-being are always at the forefront. We offer an extensive range 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:

• Competitive salaries
• Growth opportunities for promotion
• 401K with company match*

• Tuition reimbursement

• Flexible work environment
• Discretionary PTO (Paid Time Off)
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision 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, color, sex, age, national reputed company, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis 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 each other, our clients, and our patients. #LI-RL1 #LI-REMOTE Apply tot his job Apply To this Job