IT Risk & Governance Control Analyst ensuring compliance in product development for local bank. Collaborating with multiple teams for risk assessment and documentation across the product lifecycle.
About the role
- Director role overseeing CAPA Strategy and Risk Management at Bristol Myers Squibb. Leading strategic oversight of CAPA processes and driving continuous improvement initiatives.
Responsibilities
- Provide vision and define the global CAPA strategy and governance model for Research & Development by establishing standard methods, templates, taxonomies, and escalation pathways for quality events, audits/inspections, and significant non-compliances.
- Design and implement a global CAPA governance framework aligned with regulatory expectations and internal quality standards.
- Ensure CAPA processes are risk-proportionate, timely, and effective, with robust root cause analysis, sustainability checks and support risk-signal detection.
- Oversee CAPA lifecycle management, including initiation, investigation, approval, implementation, and closure.
- Drive harmonization of CAPA processes across R&D functions and ensure integration with enterprise quality systems.
- Collaborate with RDQ Global Capability Center Lead, delivering strategic leadership in supervising CAPA oversight.
- Support inspection readiness, audits, and regulatory interactions related to CAPA, as needed
- Lead continuous improvement initiatives to enhance CAPA effectiveness and cycle times.
Requirements
- B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience
- Subject matter expertise in Drug Development standards, regulators, procedures and best practices.
- Minimum 10+ years of GxP CAPA Management experience in Quality, Clinical Development or Regulatory Compliance.
- Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance.
- Extensive experience in CAPA Management and Serious Breach reporting requirements.
- Very experienced in Nonclinical, Clinical and Pharmacovigilance processes.
- Good understanding of BMS’s therapeutic areas - ICN and HOCT.
- Demonstrated analytical and conceptual capability—including proficiency in utilizing data and ability to formulate clear business questions that can be answered with data.
- Proven track record of leading and managing cross-functional teams.
- Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution.
Benefits
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- Additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
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