Senior Manager, In-Vitro Diagnostics Compliance

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t 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. You’ll 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: careers.bms.com/working-with-us.

Summary/Scope

Bristol Myers Squibb (BMS) is a global biopharmaceutical company engaged primarily in the discovery, development, and commercialization of novel therapies for the treatment of human diseases.

The Lab Planning and Execution group is part of the Translational Science (TS) team within Translational Medicine (TM). TS leads internal and external diagnostic research & development activities to support multiple disease areas of interest including hematological malignancies, inflammatory disease programs, neuroscience, cardiovascular, fibrosis, and solid tumor indications. The TS team integrates scientific and business insights of multiple functions to provide innovative solutions that will make precision medicine a reality for the patients and health care providers we serve.

This position reports to the Director, Lab Planning and Execution. The position is accountable to support execution of programs focused on the of design and development of investigational use only (IUO) biomarker assays which will be utilized to support BMS clinical trials. The position will also be accountable for the maintenance of the Design Control Quality Management System (QMS), coordinating Design Control trainings, and management of IVD material/component suppliers. The position will be required to work closely with cross-functional stakeholders including, but not limited to, members of TS, Precision Medicine, Quality Assurance, Regulatory Affairs, Program Management, and the TM CLIA Lab teams.

In addition, the position will also be accountable for the delivery of robust and compliant lab services across all TM labs in support of the BMS pipeline. This position, Sr. Manager, will support a select number of TS laboratory heads and scientists to ensure GCP compliance is met based on the intended use of each lab.

Roles and responsibilities include, but are not limited to, the following:

• Serves as a Design Control (21 CFR 820) and IVD development SME for IUO biomarker assay development programs and teams, providing independent and objective consultation in support of development activities, and in line with current best practices, policies, and procedures.
• Maintains Design Control QMS with alongside Device Quality & Combination Product and Lab Planning & Execution management; coordinates Design Control trainings for programs teams, manages document lifecycle activities within EDMS.
• Serves as a cross-functional core team member, representing Lab Planning & Execution and the TM CLIA Lab, on internal IUO biomarker assay development programs and associated clinical studies.
• Serves as vendor/supplier owner within Approved Supplier List and supports administrative, qualification, and monitoring activities for IVD material/component vendors/suppliers.
• Supports build out of new processes and workflows for TM CLIA Lab to ensure compliance to local and global regulations, requirements and standards.
• Serves as a GCP SME and liaison for TS teams and TM labs, providing independent and objective consultation in support of clinical trial activities and in line with current best practice; conducts regular internal diligence reviews to promote compliance, supports documentation of corrective actions and developing plans to prevent future errors and improve processes; supports preparation of reports for periodic reviews of key quality and performance indicators; ensures TM lab employees’ qualifications and job descriptions are maintained on the required basis; identifies and reports compliance issues to management with recommendation for resolution.
• Supports a state of audit/inspection readiness of TM labs; collaborating with TM scientists, TM CLIA Lab management, Quality Assurance, and Lab Planning & Execution on readiness activities to ensure labs are in an audit/inspection ready state.
• Supports pre-qualification visits, site initiation visits (SIV), and/or in-study monitoring visits (IMV) of the TM CLIA Lab led by IVD/diagnostic partners, internal stakeholders, or clinical trial monitors.
• May serves as a project manager to support TM CLIA Lab operational activities.
• Assure that BMS values are demonstrated in all aspects of individual actions and team interactions.

Skills/Knowledge Required:

• Bachelor’s degree in life sciences required; Master’s degree in life sciences, engineering or relevant field is preferred.
• At least 6 years of industry related experience in assay and IVD or CDx device development within pharmaceutical/biotech, IVD/medical device, or CRO.
• Strong knowledge and understanding of Design Control, product development, ISO13485, and CLSI standards.
• Experience with various technologies and platforms for IVDs and LDTs (e.g., PCR, NGS, IHC/pathology, Flow Cytometry, Mass Spectrometry).
• Experience with QMS, document management, and operating within an EDMS.
• Experience leading diagnostic development projects, protocols or studies.
• Experience in oversight and contracting with third-party vendors, CROs, and central laboratories.
• Knowledge of CLIA and CAP lab requirements.
• Knowledge of global quality standards and regulations (ICH, GCP, GLP, and GDP).
• Understanding of clinical development process.
• Demonstrates strong communication, cross-functional collaboration, skills, and a cross-cultural awareness.
• Strong organizational, analytical, and planning skills.
• Ability to work at a high level both independently, and within cross-functional teams, in a fast-paced environment with attention to detail and delivering high quality results.

Skills/Knowledge Desired:

• Experience in authoring procedural documentation, plans, protocols, and reports for regulated laboratory/site environments and/or associated with Design Control.
• Knowledge of global medical device and IVD regulations.
• Experience in Design of Experiments (DoE) and associated statistical analyses.
• Experience in implementation of IUO biomarker assays within early or late phase clinical studies.
• Knowledge of data management processes to support IVD development and/or clinical studies.
• Understanding of clinical study design, efficacy endpoints, biomarker testing and CDx co-development process.
• Knowledge of CAPA, investigations, RCA, deviations, and nonconformance.
• Experience in CLIA lab operations, reagent qualification and monitoring, and Laboratory Information Management System (LIMS).
• Ability to educate and train team members on Design Control, IVD product development, and DoE concepts.
• Experience using various tools, software, and applications for project management, knowledge management, data visualization and/or statistical analysis, or generative AI.

#LI-ONSITE

If you come across a role that intrigues you but doesn’t 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.