Key Responsibilities
The position holder is responsible and accountable for the tasks given below (non-exhaustive list):
Quality oversight of the activities and services provided by suppliers:
Serves as a single point of QA contact for indirect suppliers supporting CT manufacturing sites.
Assists with supplier qualification activities of new and current suppliers in support of Clinical and Commercial Manufacturing activities.
Initiate and Manage Supplier Quality risk assessments.
Create / negotiate and maintain Supplier Quality Agreements.
Work closely with the suppliers and involve SMEs to ensure proper and timely resolution of SCARs, Deviations, Complaint investigations and CAPAs; ensures properly documented per BMS procedures.
Evaluate and communicate supplier quality related changes, ensuring assessment per BMS change control procedures and documented in a timely fashion.
Participate in BMS audits at suppliers, as needed. Travel could be up to 10%.
Coordinate / Support Supplier Quality Vendor Changes and Supplier Issue, as well as the approval process for new suppliers.
Collect supplier quality documentation necessary to support regulatory submissions.
Hold appropriate periodic quality meetings with supplier representatives, as needed.
Hold or actively participate in joint periodic meetings with stakeholders.
Initiate and assess Change control, complaints, deviations/OOS and CAPA management in electronic system - e.g. support and quality guidance to record owners, follow up until completion, owner role as appropriate, closure in a timely manner.
Partner with stakeholders to assess overall supplier performance, including identifying product-specific quality and compliance risks and develop mitigation plans based on a risk-based approach.
Provide timely support and necessary information to QA colleagues and Quality/Supply Chain Management as required.
Act as representation for Quality Operations as required, escalate critical issues to Management as appropriate.
Author necessary quality system documents; review and update procedures for BMS Quality Management System per process ownerships.
In partnership with the CoEx sponsor, define and execute the shortand longterm strategy for the assigned Center of Excellence, ensuring alignment with global supplier quality objectives.
Serve as the CoEx subject matter expert, driving initiatives, continuous improvement, KPI performance, and accountability for effective adoption of CoEx processes across the enterprise.
Create detailed plans of the CoEx activities using Project Management tools.
Support Health Authority inspections and audits of the site, act as QA representative (SME) for functional area relevant topics.
Participate as QA representative to internal work streams, projects and improvement initiatives.
Qualifications & Experience
BS or MS or equivalent education in science, or related fields.
Minimum 3-5 years of experience in a pharmaceutical/biopharmaceutical environment including previous QA experience e28093 e.g. QA compliance role, Supplier Quality oversight
Thorough knowledge of cGMP in the pharma/Biotech industry as well as FDA, EU, and JP regulatory requirements, ICH guidelines.
Experience in Supplier Quality oversight.
Knowledge of cell therapy manufacturing processes and testing is a plus.
Good knowledge of sterile products manufacturing processes and testing. Knowledge of aseptic manufacturing processes
Experience with performing/participating in risk assessment exercises.
Thorough knowledge of and competence in core quality processes - including change control, deviations/OOS, CAPA management, investigations, APR-PQR.
Excellent investigational and QA problem solving skills e28093 able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy; able to recognize and group technical/scientific attributes and drive science based decisions in most technical areas and to a deeper level in the specific job function; and must have strong authorship and be able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.
Analytical mindset e28093 able to assess vendors quality core processes to ensure compliance with relevant guidelines and procedures; able to identify acceptable mitigation actions; able to recognize quality risks and develop contingency plans; able to assess, establish and implement new quality processes both internally and in partnership with assigned vendors. Able to author resulting procedures and tools; and able to recognize patterns in reported data and communicate strategic solutions to stake holders cross-functionally.
Quality performance / continuous improvement oriented e28093 able to create and maintain meaningful metrics for assigned activities; able to recognize trends in product data and results; and able to assess and recommend improvement measures to processes; able to drive implementation accordingly.
Good understanding of batch disposition principles, aligned with QP concept and associated duties including liaison with Health Authorities.
Skilled in planning and organizing, building relationships, innovation management and resource allocation.
Ability to make independent and objective decisions and to work under minimal supervision with cross functional teams and partners worldwide.
Team spirit. Action-oriented and customer-focused.
Negotiation and persuasion skills.
Good knowledge of most common office software.
Good verbal and written communication skills in English.
Travel: This position requires up to 10% of travel
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If you come across a role that intrigues you but doesne28099t 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.
Devens - MA - US: $105,330 - $127,638
Madison - Giralda - NJ - US: $98,440 - $119,284
New Brunswick - NJ - US: $98,440 - $119,284
Princeton - NJ - US: $98,440 - $119,284
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 employeee28099s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.a0
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit
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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.
e2808bWork-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 e2809cTransforming patientse28099 lives through sciencee284a2 e2809d, 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.
