Sr. Manager, Supplier Quality Engineer

Company: Bristol Myers Squibb
Location: Bothell
Posted on: January 12, 2021

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.Sr. Manager, Supplier Quality EngineerJob SummaryThis position is responsible to ensure that engineering and manufacturing processes are performed correctly using the right tooling, materials and processes at BMS's material suppliers and vendors used to manufacture, package and test BMS clinical and commercial cell therapy products in accordance with BMS policies, standards, procedures and international cGMP's from a quality perspective. This position is responsible to ensure that suppliers are capable of meeting BMS's quality standards. The incumbent will be responsible for the selection activities related to various suppliers including raw material, consumable, external labs, transportation suppliers, etc. used for the manufacture, package 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, authoring supplier quality system documents.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 in English a must.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. If you want to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.BMSCARTAround the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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.

Keywords: Bristol Myers Squibb, Seattle , Sr. Manager, Supplier Quality Engineer, Executive , Bothell, Washington