Senior Manager, GCP Process Excellence

Role Summary

Senior Manager, GCP Process Excellence serves as a process excellence Subject Matter Expert (SME) on process improvement, management and effectiveness. The role is responsible for the life-cycle management of controlled procedural documents (e.g., Standard Operating Procedures, Work Instructions) and managed documents (e.g., tools, guidelines) related to GCP and clinical trials. The role facilitates process development, review, approval, training and effectiveness checks, and ensures alignment with GCPs, regulations and laws. This role partners with Expertise Areas across Development to drive the consistent application of standards and promotes a culture of sustainable compliance, continuous improvement, and inspection readiness. The role leads and participates in initiatives aimed at innovation, quality, continuous process improvement and efficiency that align with organizational strategies and goals.

Responsibilities

• Process Strategy, Governance & Portfolio Leadership
  • Leads the development, periodic review, and continuous improvement of GCP and clinical trial-related processes across Clinical Development.
  • Owns the clinical process development portfolio, including prioritization, sequencing, and resourcing of initiatives in alignment with business strategy and risk.
  • Establishes and evolves process governance frameworks, standards, and best practices to ensure consistency and scalability.
• Cross-Functional Partnership & Influence
  • Drives or consults on the identification and implementation of process related change management needs
  • Drives maintenance of the Process Portal to ensure easy access to the end-to-end clinical trial-related process families
  • Partners with Process SMEs and Operational Effectiveness to implement process revisions identified in effectiveness checks
  • Partners with EAs to proactively identify learning gaps; seek out, identify, and drive process improvements with a focus on standardization
  • Drives process inspection readiness
  • Consulting on CAPAs/Quality Events related to clinical trial processes
• Additional support may include:
  • Represent Process Excellence by leading and/or participating in working groups and initiatives that drive the healthy conduct of clinical trials and helps the business scale for the future

Qualifications

• University Degree in Science and/or a relevant discipline.
• Minimum 8+ years experience with a biopharmaceutical company and/or CRO and a track record of success in global clinical development or related disciplines including:
• Extensive experience in activities related to process improvement; SOP development and review, role-based curriculum management
• Proven ability to design/evolve and implement GCP related processes (e.g., SOPs, Work Instructions) in a fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic business model
• Experience in global clinical study/site management
• Understanding of the processes required to operationally execute clinical trials to a high standard of excellence
• Strong knowledge of GCP, global regulatory and compliance requirements for clinical trials
• Knowledge of industry trends and best practices for process quality, efficiency, compliance, and effectiveness
• Knowledge of Process Mapping strategies and tools strongly preferred
• Knowledge of managing within EDMS and LMS systems
• Demonstrated ability to coach, motivate and influence high performing colleagues across areas to deliver
• Ability to execute work independently and with minimal supervision
• Ability to respond to change with agility, resilience, innovation, and optimism, seeking solutions based on creative problem solving, lessons learned and well-reasoned risk taking
• Detail oriented and possess technical expertise
• Strong communication (written, verbal, presentation) and analytical skills
• Alignment with Core Values: Fiercely Innovative, Open Culture, Purposeful Urgency, Passion for Excellence, Commitment to People

Additional Requirements

• Able to accommodate limited travel (may include international travel) according to business need (~10%).