Senior Specialist, Lab Compliance (GLP & Bioanalysis)
Bristol Myers Squibb
This listing was originally posted on Bristol Myers Squibb's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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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.
Position Summary
The Senior Specialist, Lab Compliance (GLP & Bioanalysis) is accountable to support the broad GLP & Bioanalysis compliance activities to ensure regulations, standards, and requirements are met based on assay intended use within Bioanalysis. This role supports laboratories to ensure robust, compliant lab services and data integrity across internal and external CROs laboratories, including vendor qualification and performance monitoring. The position supports activities for audit readiness, global regulatory inspections, and continuous improvement initiatives, partnering cross-functionally to support the organization’s pipeline and business objectives. The position is to serve as a support and training resource for Bioanalysis organization and provide Quality Management System (QMS) role support within other applications and databases. This role will work with cross-functional stakeholders for various compliance and/or operational efforts in support of the BMS pipeline.
Key Responsibilities:
GLP & Bioanalysis Compliance SupportSupports broader compliance efforts across Bioanalysis to ensure the requisite GxP standards are applied based on the intended use within the internal and/or external lab.
Supports activities to maintain state of audit/inspection readiness of internal regulated Bioanalysis lab; may participate in laboratory walkthroughs, QC of associated documentation, and/or audits/inspections/site visits.
Support management of the GLP quality systems, best practices, and training programs.
Supports Bioanalysis vendor compliance management activities according to established processes.
Support Bioanalysis labs to ensure resolution of deviations, CAPAs, and change controls across internal and external labs, ensuring timely and effective corrective actions.
Provides document management support within Electronic Document Management System (EDMS).
Assure that BMS values are demonstrated in all aspects of individual actions and team interactions.
Qualifications & Experience
Bachelor’s Degree with 4+ years of lab compliance, bioanalysis, or industry experience OR Master’s Degree with 2+ years of lab compliance, bioanalysis, or industry experience
General knowledge in GLP and bioanalytical laboratory compliance and global quality standards and regulations, including GLP (OECD, ICH M10), GCP (ICH E6), GMP (21 CFR Parts 210/211), GDP (Good Documentation Practice), FDA Quality System Regulation (21 CFR Part 58)), IVDR (In Vitro Diagnostic Regulation) for EU compliance, Data Integrity principles (ALCOA+)
Experience in training team members in procedures, processes, tools, or applications in an effective manner.
Experience with vendor/CRO management, audit/inspection readiness, and regulatory submissions.
Experience with various biomarker assay technologies, systems, and platforms.
Understanding of compliance to various types and of procedural documents and completion of forms, logs, and templates within document hierarchy.
Familiarity with digital quality systems such as LIMS/ELN, eQMS, audit-management platforms, and data integrity tools.
Effective use of Microsoft Office suite, SharePoint, and Adobe Acrobat.
Demonstrates effective communication skills, cross-functional collaboration skills, and a cross-cultural awareness.
Demonstrates organizational, analytical, and planning skills.
Ability to work both independently and within cross-functional teams.
Ability to work in a fast-paced environment with attention to detail and delivering high quality results.
#LI-Hybrid
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.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
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.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
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.
Supporting People with Disabilities
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.
Candidate Rights
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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
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