RDQ CTQA Inspection Lead

Job content

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Key Responsibilities and Major Duties

Inspection readiness and preparation

• Acts as CTQA Inspection Lead for high risk submissions, contributing to inspection readiness strategy and activities.
• Conducts assessments that determine risk of upcoming inspection to guide resourcing and readiness efforts.
• Ensures required business stakeholders and GQ are notified of anticipated and announced GCP inspections.
• Creates and maintains an inspection tool box to facilitate the coordination of worldwide Health Authority GCP inspections.
• Ensures strategic inspection preparation with all stakeholders focused on areas of highest impact through e.g. the conduct of mock inspection and preparation of story boards.
• Influences, anticipates and acts on trends and changes in the international regulatory environment and new developments internally and externally in the GCP area to adapt inspection readiness, as needed.
• Conducts pre-inspection visits and/or sponsor assessments, as needed.
• Leads/ to HA inspection dossier preparation and document compilation/QC.
• Engages GPO on inspection support.
• Ensures all GCP inspections are tracked and entered into QMS
  

Inspection management and follow-up

• Leads key regulatory agency inspections of high risk and impact to the company, including anticipating issues that may pose risk, and provides strategic input into SME(s) to be engaged and BMS position on inspection responses.
• Reviews and approves all documents and responses shared with inspectors to mitigate potential risks and ensures appropriate stakeholders are involved.
• Facilitates collection of responses to inspection findings, critically evaluates proposed CAPAs, and maintains oversight of health authority commitments.
• Influences the way inspections are conducted by the Health Authorities through being a constructive partner in improving future ways of working.
• Monitors the GCP landscape for new trends in inspection focus in partnership with PEARL, GROe and stakeholders.
• Identifies trends and ensures lessons learned from inspections to proactively prevent risks in future submissions.
• Reviews results/analyses of GCP inspections, including inspections of clinical investigator sites, vendors, and sponsor systems to assess regulatory compliance and, where appropriate, addresses issues with BMS management to assure proper follow-up and resolution.
  

Overall

• Maintains audit currency by conducting GCP audits, as assigned.
• Provide advice and counsel concerning GCP regulatory requirements.
• Collaborates with industry colleagues through benchmarking of regulatory activities to influence regulatory inspection approaches.
• Prioritizes and focuses on matters of significance.
• Maintains an in-depth knowledge of governmental regulations affecting GCP and development of medicines.
• Builds and maintains strong relationships and productive relationships with key stakeholders and GPO throughout BMS, across RDQ and with GCCCI.
• Influences on matters that affect quality and compliance in GCP activities.
• Provides mentoring for new RDQ-CTQA staff, as assigned.
• Represents RDQ-CTQA position during internal and external meetings.
• Act as an advisor and back-up to the Head of Clinical Trial Inspection Management
  

(Disclaimer The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.