Senior Group Risk Specialist – Enterprise Risk
TD
Associate Director, R&D Quality Governance
Bristol Myers Squibb
full-time
Posted on:
Location Type: Hybrid
Location: New Brunswick • New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $163,850 - $198,543 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Support the implementation of an effective R&D Quality Risk Governance framework in alignment with Enterprise Risk Management principles.
- Facilitate the roll-up of relevant R&D risks and insights for reporting to Global Quality Councils, Enterprise Risk Committees, and relevant Drug Development Governance forums and assure alignment with regulatory requirements, industry standards, and best practices.
- Partner with Quality Council Co-Chairs, to support continuous assessment, evaluation, and communication of strategic / quality / operational risks within R&D.
- Support the GCP serious non-compliance management process, including management of Serious Breaches.
- Conduct comprehensive data analysis and interrogation of data to derive meaningful, actionable insights that support data-driven decision-making at Global GxP Quality Councils.
- Support CAPA management by facilitating root cause investigations, review and approval of CAPA plans.
- Partner with Global Quality to ensure quality metrics are aligned with organizational goals, regulatory requirements, and support development of tools and reports to drive inspection readiness.
- Partner with Global Quality to provide insights on quality, compliance and operational risks to products in clinical trials and post marketing.
- Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to the business and Health Authorities, as needed.
- Champion a Quality Mindset and ensure compliance with key ICH guidelines (e.g. E8, E6, E9, Q9) and other relevant regulatory requirements.
- Other Drive continuous improvement initiatives to enhance quality processes and systems. Develop and deliver training programs to enhance quality awareness and competencies across the organization. Provide leadership, guidance, development and coaching for management of significant quality issues. Establish strong partnerships with business stakeholders. External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers. Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation. Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level. Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline. Lead and/or contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department. Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to indirect reports/peers within the organization. May influence the external environment through interactions with regulators, trade associations, or professional societies. Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.
Requirements
- B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience
- Minimum 10+ years QA experience or relevant experience in quality management, Drug Development, GCP, GVP, GLP and regulatory compliance.
- Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance.
- Very experienced in Quality Council Management.
- In-depth knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management.
- Understanding of BMS’s therapeutic areas – HOCT and ICN.
- Extensive experience in regulatory inspection preparation, management, and related follow-up.
- Demonstrated analytical and conceptual capability—including proficiency in utilizing data and ability to formulate clear business questions that can be answered with data.
- Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution.
Benefits
- Medical, pharmacy, dental and vision care.
- Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
- Financial well-being resources and a 401(K).
- Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
- Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
- Parental, caregiver, bereavement, and military leave.
- Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
- Other perks like tuition reimbursement and a recognition program.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality AssuranceRisk ManagementData AnalysisCAPA ManagementRegulatory ComplianceClinical ResearchQuality MetricsRisk AssessmentRisk EvaluationRegulatory Inspection Preparation
Soft skills
LeadershipCommunicationProblem-SolvingCoachingCollaborationContinuous ImprovementStrategic ThinkingMentoringGuidancePartnership Building
