Senior Manager, Ex Material Supplier Quality
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.
PURPOSE AND SCOPE OF POSITION:
This position provides quality oversight for material suppliers and vendors used to manufacture, package and test BMS clinical and commercial cell therapy products (“BMS CTDO”) in accordance with policies, standards, procedures, and international cGMP’s. The incumbent will be responsible for the approval 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. To the latter, the incumbent will also have additional responsibilities that include but are not limited to, providing quality support to internal BMS stakeholders and SMEs, reviewing/ approving product related GMP documents, authoring supplier quality system documents.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Thorough knowledge of cGMP in the pharma/Biotech industry as well as FDA, EU, and JP regulatory requirements, ICH guidelines.
- Knowledge of cell therapy manufacturing processes and testing is preferred.
- Good knowledge of sterile products manufacturing processes and testing. Knowledge of aseptic manufacturing processes
- Experience with performing/participating in risk assessment exercises.
- Experience in Supplier Quality oversight.
- 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 – e.g.
- -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.
- 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 in partnership with assigned 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 assigned activities.
- 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.
DUTIES AND 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 – e.g.
- Serves as the site single point of QA contact for suppliers for cell therapy program.
- Assists with supplier qualification activities of new and current suppliers in support of Clinical and Commercial Manufacturing activities.
- Initiate and Manager 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 Deviations, Complaint investigations and CAPAs; ensures properly documented per Celgene procedures.
- Evaluate and communicate supplier quality related changes, ensuring assessment per Celgene change control procedures and documented in a timely fashion.
- Collect APR-PQR related information and data per Celgene requirements.
- Participate in Celgene audits at suppliers, as needed. Travel could be up to 25%.
- Coordinate / Support the Supplier Quality Review Board to promote discussions surrounding Supplier Quality Vendor Changes and Supplier Issue, as well as the approval process for new suppliers.
- Measure supplier quality performance, periodically collect and share quality performance metrics. Identify potential trends, working closely with supplier to define possible areas for improvement and associated implementation plan.
- 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 Celgene 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.
WORKING CONDITIONS EDUCATION AND EXPERIENCE (As Applicable)
- Minimum B.S. education in science, engineering, or related fields. MS or additional certifications preferred.
- Minimum of 8 years in the pharmaceutical or related industry, with of 4-6 years of supplier quality management is required
- Equivalent combination of education and experience acceptable.
- Occasional travel required up to 25%
- The incumbent may be required to enter controlled areas supporting areas
WORKING CONDITIONS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
Around 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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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