Director GCP Compliance - CRO Services

United Biosource Corporation

4h•Remote

About The Position

As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle - from clinical trial support to real-world evidence generation. Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values of Respect, Accountability, Innovation, Quality, Integrity, and Collaboration. We believe in an inclusive workplace that fosters creativity. If you are seeking a career that will challenge, inspire, and reward you, join us at UBC! The Director of GCP Compliance develops the strategy for, and directs the overall management of the Clinical QC, Controlled Document/Training, and Continuous Improvement teams within Global Quality Compliance. Additionally, the Director GCP Compliance is responsible for the strategy to ensure that all 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.

Requirements

Deep expertise in Computer System Validation (CSV) using both waterfall and agile methodologies.
Strong working knowledge of clinical research regulations related 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 within 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, oversight, 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.
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 continuous 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 management solutions:
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 achieve explicit delivery dates and milestones

Responsibilities

Computer System Validation (CSV) expertise: Deep expertise in both waterfall and agile CSV methodologies, strong working knowledge of clinical research regulations related 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 within 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, oversight, 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 capacity (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 Continuous Improvement Administrator and related CAPA Analysts to develop effective working practices for the execution and administration of a corporate continuous 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 oversight for the corporate UBC training program. Responsible for managing employee training files and related documentation for the UBC organization including the establishment of role based training matrices.
Lead a team that supports regulatory inspections related to both UBC's overall GCP/GVP compliance across all service areas as well as supporting the regulatory inspections of clients.
Establish the vision and implement the strategy for GCP/GVP Compliance within UBC to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP Guidelines, and UBC'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 continuous improvement of risk-based practices and approaches related to building quality within clinical research activities.
Leads the team of internal GCP experts within the Quality & Regulatory function that guide operations delivery work instructions to ensure compliance as well as providing input into functional requirements related to GCP to the product development teams.
Engages as a thought leader in industry groups as to be UBC's voice and an advocate for our clients as GCP guidance & regulations continue to evolve.
Oversee required annual company-wide GCP training.
Reviews inspection activities and results for developing lessons learned.
Responsible for ongoing identification of opportunities to further develop and improve GCP Inspection Management strategy, processes, tools, and templates.