Sr. Manager, Digital Products QA

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.

PURPOSE AND SCOPE OF POSITION:

Reporting to the Director, Device and Combination Product QA, the Sr. Manager, Digital Products QA is responsible for providing technical quality and compliance oversight to the BMS pipeline of Diagnostics and Digital Health products currently in development. This role will have QA responsibility over digital health software development and commercialization activities, ensuring compliance to governing regulations for Software as a Medical Device and delivering a high level of product quality. The product portfolio includes digital applications, wearables and digital solutions within the medical device space.

This position is an individual contributor role, providing customer-focused, cross-functional support to Research and Early Development and Product Development. This position will work with internal and external partners including software developers, testers, project managers, and commercial teams to deliver on project milestones.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

• Strong understanding of global GCP, cGMP and GDP standards and regulations with a focus on quality system and quality engineering principles for digital products and devices (e.g. software as a medical device).
• Expert knowledge of the regulatory and compliance requirements for design controls and combination products (21 CFR Part 4, 21 CFR Part 820, ISO 13485 and ISO 14971, IEC 62304, 93/42/EEC).
• Awareness of pharmaceutical and biologic regulations and standards including 21 CFR Part 210, 21 CFR part 600, 2010/83/EC and relevant ICH guidelines.
• Knowledge of Risk Management and statistical analysis tools (e.g. Risk Analysis, FMEA, FTA, etc.)
• Cross-functional experience within the Healthcare space with device and pharmaceutical/biopharmaceutical experience preferred.
• Oversight of the device quality requirements as it relates to device design inputs and design outputs; verification / validation testing, delivery, and eventual post-market support to ensure delivery of device milestones.
• Provide input into the assessment of technologies as part of the long-range device plans, and products and services aligned with establish global connected digital health solutions for our products.
• Develop internal and external stakeholder relationships to gather input into device product or platform projects.

DUTIES AND RESPONSIBILITIES

• Provide guidance to the organization on quality compliance implications of digital health technologies in the healthcare space.
• Assist in the identification and delivery of software solutions for smart devices and digital health projects through feasibility, development, qualification, launch, and post-market life cycle phases of device development.
• Primary areas of focus will include assisting with the project plan, user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, development oversight and design outputs. The role includes extensive collaboration with internal and external partners.
• Participate in various areas of software device development (e.g. design control, change control, device regulatory strategy, etc.) and have software technical knowledge to assist in the identification and assessment of new/emerging technologies.
• Remain current with the changing landscape of regulations in the global digital device space as it relates to Health Authority regulations and requirements (e.g. FDA pre-cert program).
• Evaluates compliance risks and develops risk mitigation strategies for digital health products as well as the business
• Supports health authority submissions and/or communications
• Manages supplier quality activities, i.e. supplier evaluations, audits, and corrective actions
• Ensure compliance to GCP, cGMPs, GDPs, QSRs, ISO, IEC, and Global Health Authority Requirements (e.g.21CFR, MDR) as well as applicable BMS policies and standards
• Support inspection readiness at BMS and provide back/front-room support, as-needed, during third-party inspections.
• Supports investigations and serves as technical quality SME for quality events related to digital technologies.
• May require up to 15% globally.

EDUCATION AND EXPERIENCE

College or University degree required; advanced degree preferred. Technical degree focus areas are strongly preferred including engineering or software development (software, electrical, biomedical and/or systems). Minimum 8 years relevant work experience, specifically in the regulated healthcare space (pharmaceutics, biologics or medical devices). Minimum 2 years of leadership experience.

WORKING CONDITIONS: (US Only)

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10%of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

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.