Sr. Manager, Supplier Quality Engineer

Working with Us
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 rich in diversity. 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:

This position is responsible to ensure that engineering and manufacturing processes are performed correctly using the right tooling, materials, and processes at BMSs material suppliers and vendors used to manufacture, package, and test BMS clinical and commercial cell therapy products following BMS policies, standards, procedures and international cGMPs from a quality perspective. This position is responsible to ensure that suppliers are capable of meeting BMSs quality standards. The incumbent will be responsible for the selection activities related to various suppliers including raw materials, consumables, external labs, transportation suppliers, etc. used for the manufacture, packaging, and testing of CAR-T products. The incumbent will also have additional responsibilities that include but are not limited to, providing quality support to BMS stakeholders and SMEs, reviewing/ approving product-related GMP documents, and authoring supplier quality system documents.

DUTIES AND RESPONSIBILITIES:

The position holder is responsible and accountable for the tasks given below (non-exhaustive list):

• Quality representative for projects related to supplier e.g.

  • second sourcing efforts, transfer to/from vendors, inter site transfers

• Partner with stakeholders to select suppliers, including raw material, consumable, external labs, transportation suppliers, etc. used for the manufacture, package and testing of CAR-T products.

  • Develop and submit supplier questionnaires to assess the quality and technical capabilities of the supplier.

  • Depending on the risk identified, technical diligence visit of the supplier can be performed in place or in addition to the questionnaire.

  • Participate in GMP/GDP audits at suppliers for high risk vendors.

  • Assists with qualification activities of new and current suppliers in support of Clinical and Commercial Manufacturing activities.

• Initiate and assess change control, deviations and CAPA management in electronic system for complex and/or multi-site vendor related events.

  • Work closely with the suppliers and involve SMEs to ensure proper and timely resolution of Deviations, Complaint investigations and CAPAs; ensures properly documented per BMS procedures.

  • Evaluate supplier quality related changes are implemented at the vendor per BMS change control procedures.

• Partner with stakeholders to identify high risk supplier, including identifying product-specific quality and compliance risks and develop mitigation plans that implementable across all sites.

  • Initiate and manage supplier risk assessments

  • Depending on the risk identified, technical diligence visit of the supplier will be required.

• Provide timely support and necessary information to QA colleagues and Quality/Supply Chain Management as required.

  • Participate quality meetings with supplier representatives, as requested.

  • Hold or actively participate in joint periodic meetings with stakeholders.

• 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.

• 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.

Required Competencies:

• Thorough knowledge of cGMP in the pharma, biotech and medical device industries as well as FDA, EU, and JP regulatory requirements, ICH guidelines.

• Good knowledge of cell therapy manufacturing processes and testing is required.

• Good knowledge of aseptic manufacturing processes and testing.

• Good knowledge of device manufacturing processes and testing.

• Experience with performing and participating in risk assessment exercises.

• Experience in Supplier Quality oversight.

• Experience in technical audits of manufacturers in the pharma, biotech and medical device industries.

• Thorough knowledge of and competence in core quality processes - including change control, deviations, OOS, CAPA management, and supplier complaints.

• Excellent investigational and QA problem solving skills e.g.

  • -Able to interpret problems and effectively prepare surrounding communication in a productive manner to supplier, 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.

  • 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 e.g.

  • 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 with vendors. Able to author resulting procedures and tools.

  • Able to recognize patterns in reported data and communicate strategic solutions to stake holders cross-functionally.

• Quality performance / continuous improvement oriented e.g.

  • Able to create and maintain meaningful metrics for critical vendors.

  • Able to recognize trends in product data and results.

  • 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 (Microsoft Office).

• Good verbal and written communication skills.

Education and Experience:

• BS or MS or equivalent education in Science, or related fields.

• Minimum 5-8 years of experience in a pharmaceutical/ biopharmaceutical/medical device environment including previous QA experience e.g. QA compliance role, Supplier Quality oversight

• Quality Certifications preferred.

#BMSCART, #Veteran, #LI-Hybrid

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, 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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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.

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