Senior Manager, In-Vitro Diagnostics Compliance - Princeton, NJ
Senior Manager, In-Vitro Diagnostics Compliance - Princeton, NJ
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Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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.
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:
Bachelors degree in life sciences required; Masters 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.
Required Experience:
Senior Manager
Employment Type
Full Time
