Regional Clinical Compliance Lead

Working with Us
Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

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. Read more: role will support and enable corporate Global Development Operations GDO objectives through:

Design and execution of Compliance Assessments to support risk identification/management assuring GDO is inspection ready. Training/Communication including GCP consultation with the operational organization to ensure issues are managed and quality culture is embedded during trial delivery. Identification management and reporting of compliance gaps and systemic issues with proactive monitoring for signals and trends including notification and/or escalation of emerging and significant risks to relevant senior management and governance bodies as appropriate. Leading or facilitating assessment of business risk at the appropriate level including local/Country Regional Functional and Vendor/Supplier. Leading or supporting Continuous Improvement and Process Improvement activities. Supporting R&D Quality to deliver the GDO Audit Management Plan. Providing Clinical Trial Inspection Support for Sponsor and Site Inspections.

Responsibilities include:

• Support Regional Clinical Operations (RCO) Countries/Clusters local study teams and sites to assure Inspection and Audit Readiness at all times in partnership with RCO TDS Global Quality et al.
• Support RCO with CAPA management by driving Root Cause Analysis and CAPA development; follow-up regional/site-level CAPA delivery to closure.
• Inspection Support: Provide Inspection Management Training. Coordinate site and sponsor inspections by Health Authorities depending on the Inspection type and conduct Pre-inspection visits as needed.
• Support end-to-end Risk Management at appropriate level including local/Country Regional Functional and Vendor/Supplier.
• Provide oversight of Compliance Issue Management and act as primary contact for GCP & Regulatory Compliance questions.
• Lead Country/Cluster Compliance Forum in partnership with the clinical operation team(s) to share lessons learned key metrics (KPI/KRI) and build and sustain a Quality Culture escalating trends and significant issues to appropriate governance levels.
• Partnering with RCO to identify gaps/needs in training (Regional Country/Cluster Process Improvements) and provide/facilitate local training as needed.
• As the scope of Global Development Operations includes registrational and non registrational data generation (NRDG) RCC activities will span Phase I through IV studies including Investigator-Sponsored Research and Real World Data that context partner with NRDG teams to enhance GCP Compliance in partnership with Regional/Country Medical.
• Work with RCO and Global Quality to foster a regional cross- functional mindset of Quality Excellence Quality by Design and Inspection Readiness at all times.
• Design and execution of Compliance Assessments to support risk identification/management.
• Support Vendor oversight in alignment with RCO expectations.
• Oversight of local Procedural Document creation and maintenance; provide training on new and revised GCP compliance related SOPs/Regulations as appropriate.
• Work with other stakeholders such as Medical Legal or Regulatory Safety Business Insights and Analytics and Development to ensure Compliance concerns are aligned across the Region and Globally.

Knowledge Skills Abilities:

• At least 8 years of relevant industry experience in clinical trial operations and/or Good Clinical Practice is required.
• Significant global clinical trial expertise and a successful track record of leading through influence and working across complex global organizational matrices.
• Experience in matrix management and training is desirable with the ability to engage and influence others.
• Good communication skills with a proven ability to effectively engage and manage key internal stakeholders (in various functions and geographies) as well as external stakeholders (including Health Authorities).
• Good presentation and negotiation skills with the ability to resolve conflict in a constructive timely manner within a cross-functional team.
• Ability to manage multiple projects simultaneously to ensure timely execution of tasks. Attention to detail with excellent planning time management and organizational skills.
• Ability to drive and manage issue escalation.
• Have a strategic mindset to translate local/regional/process needs into effective process development.
• The candidate will demonstrate the ability to adopt a biopharma enterprise-wide and entrepreneurial mindset to act with speed accountability and integrity and to have fun along the way.
• Well versed in industry trends and emerging industry dynamics concerning clinical trial processes and data collection.
• Experience and/or knowledge of risk management in a regulated industry with a strong emphasis on GCP (Good Clinical Practice) Quality and Operations.
• Priority given to experience in GCP Quality and Operations.

Education/Experience/ Licenses/Certifications:

• A minimum of a bachelors degree (or equivalent degree) is required; a degree in a life science (or equivalent) is preferred.
• Travel: Up to 30% domestic and international travel may be required.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to gender identity race color religion sexual orientation national origin or disability.

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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