Laboratory Compliance Manager Translational Medicine
Laboratory Compliance Manager Translational Medicine
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1 Vacancy
Job Description
Working with Us
Challenging. Meaningful. Lifechanging. 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 highachieving 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: degree in life sciences with a minimum of 5 years of clinical lab operations quality and/or compliance; experience in pharma biotech CRO or medical device preferred. MS in relevant life sciences field preferred. Previous lab supervisor experience preferred.
Strong knowledge in CLIA/CAP lab requirements and/or ISO13485 Quality Management System Regulation (QMSR).
Knowledge of global quality standards and regulations (GCP GLP GDP and ICH GCP) and ALCOA principles.
Knowledge in various diagnostics technologies and platforms (e.g. PCR NGS IHC/pathology Flow Cytometry Mass Spectrometry Imaging etc..
Experience in diagnostic lab operations biomarker assay verification/validation material qualification and monitoring of quality controls.
Experience with preparation and readiness for audit/inspections lab/site qualifications and/or monitoring visits performed internally by Quality Assurance teams and/or externally by health authorities diagnostics partners or monitoring personnel.
Experience in using Quality Management Systems Document Control systems and quality/compliance improvement tools and techniques.
Effective use of Microsoft Office suite SharePoint and Adobe Acrobat.
Demonstrates strong communication skills crossfunctional collaboration skills and a crosscultural awareness.
Demonstrates strong organizational analytical planning decisionmaking skills.
Ability to work at a high level both independently and within crossfunctional teams.
Ability to work in a fastpaced environment with attention to detail and delivering high quality results.
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 group is part of the Translational Sciences (TS) team with 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 . He/she is accountable for the delivery of robust and compliant lab services across all TM labs including the TM CLIA Laboratory in support of the BMS pipeline. This position Manager will support various TS laboratory heads and scientists to ensure GCP compliance is met based on the intended use of each lab. The employee will also be required to work with crossfunctional stakeholders to ensure compliance and audit/inspection readiness of for the TM CLIA Laboratory.
Roles and responsibilities include but are not limited to the following:
- Serves as a GCP Subject Matter Expert for TS teams and TM labs providing independent and objective consultation in support of clinical trial activities and in line with current best practice.
- Ensures that record keeping is complete and records are maintained appropriately by lab staff; includes ensuring the requisite standards are applied based on the intended use of the lab.
- Conducts regular internal diligence reviews to promote compliance in the labs.
- Responsible for documenting corrective actions and developing plans to prevent future errors and improve processes.
- Prepares reports for periodic reviews of key quality and performance indicators across the TM labs.
- Ensures that TM lab employees qualifications and job descriptions are maintained on the required basis.
- Strives to continuously improve lab quality and productivity simultaneously.
- May manage the Training Curricula for the organization; optimize assignment of the appropriate training to the appropriate individuals; provide metrics on compliance and identifies ways to improve adherence to training plans.
- Identifies and reports compliance issues to management with recommendation for resolution.
- As required run reports and conduct data analysis to support monitoring of key compliance performance indicators; support developing and reporting to management utilizing technical knowledge and laboratory experience; support preparation of compliance data for the monthly and/or quarterly presentations.
- Ensures compliance with CLIA/CAP laboratory licensing/permitting accreditation regulatory standards and policies by providing leadership and guidance to staff to ensure that policies processes and procedures are established current and adhered to by all laboratory staff.
- Leads and maintains Out of State clinical lab licensing and permitting for CLIA lab.
- Ensures and maintains a state of audit/inspection readiness; performs compliance walkthroughs with CLIA management and supervisors TM lab staff Quality Assurance and Lab Operations as part of audit/inspection readiness activities to ensure labs are in an audit/inspection ready state.
- Leads the implementation and improvement of the internal and external audit/inspection process for CLIA lab; coordinate front room/ back room activities; support generation of audit/inspection responses and observation resolution through CAPA.
- Drive lab and site compliance to regulatory enterprise and global requirements through building positive crossfunctional relationships to meet unified business objectives.
- May support CLIA supervisors with oversight of proficiency testing programs and external assessments; competency assessments; LIMS and procedural training; and other compliance associated processes.
- Support maintenance of CLIA lab QMS and document management.
- Assure that BMS values are demonstrated in all aspects of individual actions and team interactions.
Skills/Knowledge Required:
- Bachelors degree in in life sciences Masters degree in relevant life sciences field preferred.
- A minimum of 5 years of clinical lab operations quality and/or compliance experience required; experience in pharma biotech CRO or medical device preferred.
- Strong knowledge in CLIA/CAP lab requirements and/or ISO13485 Quality Management System Regulation (QMSR).
- Knowledge of global quality standards and regulations (GCP GLP GDP and ICH GCP); knowledge of ALCOA principles.
- Knowledge in various diagnostic technologies and platforms (e.g. PCR NGS IHC/pathology Flow Cytometry Mass Spectrometry Imaging etc..
- Experience in diagnostic lab operations biomarker assay verification/validation material qualification and monitoring of quality controls.
- Experience with preparation and readiness for audit/inspections/qualification visits performed internally by Quality Assurance teams and/or externally by health authorities diagnostics partners or monitoring personnel.
- Experience in using quality management systems document control systems and quality/compliance improvement tools and techniques.
- Effective use of Microsoft Office suite SharePoint and Adobe Acrobat.
- Demonstrates strong communication skills crossfunctional collaboration skills and a crosscultural awareness.
- Demonstrates strong organizational analytical planning decisionmaking skills.
- Ability to work at a high level both independently and within crossfunctional teams.
- Ability to work in a fastpaced environment with attention to detail and delivering high quality results.
Skills/Knowledge Desired:
- Experience in audit/inspection readiness timeline management mock inspections and interview preparation; conducting internal audits (selfinspection) serving in critical front room/ back room roles for external audits/inspections.
- Experience in CAPA investigations RCA deviations and nonconformance.
- Experience as a CLIA lab supervisor.
- Ability to use tools and information technology systems for project management (e.g. Smartsheets MS Project MS Teams MS Visio) data visualization and/or statistical analysis (e.g. Spotfire Tableau JMP) or generative AI (e.g. ChatGPT).
- Knowledge of Design Control 21 CFR 820 ISO13845 In Vitro Diagnostic Medical Device Regulation (IVDR) and New York State clinical laboratory requirements.
- Experience in leading Out of State clinical lab licensing and permitting.
- Experience in using a regulated LIMS.
- Knowledge in drug development diagnostic development companion diagnostics and/or translational development processes.
- Experience in working with diagnostics and biomarker assays being utilized for exploratory purposes and investigational use only.
- Experience in biospecimen lifecycle management data management activities and/or oversight and monitoring of laboratories for clinical studies.
If you come across a role that intrigues you but doesnt 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 Lifechanging 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.
Onsite Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100 of shifts onsite at your assigned facility. Sitebydesign 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 fieldbased and remotebydesign 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 . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Manager
Employment Type
Full-Time
