Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management.
Partner with Drug Development to embed Quality by Design principles and identify study specific critical to quality (CtQ) data, processes and vendors and ensure adequate risk mitigation strategies have been implemented.
During trial conduct, provide feedback on risks to study specific critical to quality factors and adjust mitigation strategies when new or unanticipated issues arise.
Conduct quality assurance spot checks to ensure risk mitigation strategies are accurately translated into operational plans.
Assist in defining and establishing Acceptable Ranges/QTL and KRIs for CtQ data.
Provide quality and compliance consultation to clinical trials teams throughout study lifecycle.
Provide regulatory intelligence on current and upcoming regulations to ensure compliance with requirements.
Partner with stakeholders to manage significant quality issues/noncompliance and important protocol deviations for CtQ data, processes and vendors.
Ensure rapid communication and escalation of quality issues to the business and Health Authorities as needed.
Drive quality into the business through proactive quality support, mentoring and/or coaching.

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 8+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance.
Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance
Very experienced in Risk Based Quality Management principles.
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.
Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.

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) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, 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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

Quality Narrativerisk-based quality managementQuality by Design principlesquality assuranceAcceptable RangesKey Risk Indicatorsregulatory compliancerisk assessmentrisk analysisclinical research processes

Soft skills

problem-solvinganalytical capabilitycommunicationmentoringcoachingstakeholder managementproject managementfeedback provisionadaptabilityproactive communication