Senior Director, Global Product Quality Lead, Cell Therapy

Company: Bristol-Myers Squibb Company
Location: Summit
Posted on: August 7, 2022

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.Location: Summit NJ, Seattle WA or Devens MACell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy, the growth potential of the science - and its ability to help patients - is incredible.Scope of the roleThe Senior Director, Cell Therapy Global Product Quality Lead (Sr. Dir. CT-GPQL) is accountable for delivering commercially robust and globally compliant quality strategies and outcomes that sustain the product supply chain throughout the product lifecycle. Manages product quality risk throughout the product lifecycle, including oversight of process and analytical lifecycle, control strategies, comparability, specifications, and stability. Monitors commercial operations through periodic reviews of process and method performance, including Annual Product Quality Reviews. Provides general support and leadership within the Global Product Quality organization. Authors designated sections of regulatory filings, reviews all sections for clarity, technical persuasiveness, consistency and completeness, and serves as a subject matter expert and strategist during health authority inspections. The scope of the role includes one or more cell therapy programs (clinical/commercial), encompassing the internal and external manufacturing and testing of cell banks, gene delivery materials, drug product intermediates, drug product, and finished labeled drug product.This role can be in Seattle, WA, Summit, NJ or Devens, MA and reports to the Head of Global Product Quality, Cell Therapies.Key responsibilities:The Senior Director, Cell Therapy Global Product Quality Lead will lead a team of Product Quality Leaders to:Partner across Global Product Quality, Analytical Sciences and Technology, CT Development, CT Operations, and CT Regulatory CMC to define and deliver product quality strategies that comply with internal and external quality standards and regulatory requirements.Provide global product quality oversight of assigned areas of responsibility and support manufacturing operations including developing and maintaining relationships with partner organizations.Supports the overall Quality plan based on Cell Therapy Development and Operations annual goals, critical projects, and/or life-cycle support for Product Team objectives, regulatory commitments, and process and product monitoring KPIs.Provide quality expertise in accordance with global regulatory requirements and internal policies in support of product characterization, product specifications, method validation, stability and comparability assessments for manufacturing and site changes.Drive timely and compliant completion of the Annual Product Quality Review ensuring coordination with leads of contributing.Perform Quality review of CMC sections of regulatory submissions and responses. May author CMC sections or responses to queries, as needed.Represent Quality in CMC meetings with global regulatory agencies and during regulatory inspections.Represent Quality on the CMC and GO-CT teams.Act as QA approver for product specifications and product labeling as needed.Provide supportive quality oversight and guidance during product launch to program teams.Provide strategic guidance and facilitate the timely implementation of manufacturing and testing changes. May own global changes and documentation management activities as required.Assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase.Influence industry and health authorities and ensure staff present at external conferencesIdentify and mentor future leadersThis role will partner with Analytical Sciences and Technology, Process and Analytical Development, Manufacturing Sciences and Technologies, Stability, Quality Assurance, Quality Control, GRS CMC to develop and execute product quality strategies.Professional experience and qualifications Master's or PhD degree in Biochemistry, Immunology, Molecular Biology, Chemistry, Biology or corresponding engineering discipline preferredAt least 12 years of experience in cell therapy, pharmaceutical and/or biotechnology fields in Manufacturing Operations or Quality rolesKnowledge and Skills: The Sr. Dir. CT-GPQL, in the nascent field of cell therapy, must be skilled in the development of quality strategies with little external guidance, ensuring product quality throughout the lifecycle. The Sr. Dir. CT-GPQL is a motivated, engaged, solutions-driven, strategic, and adaptable leader who supports the ED CTQ GPQ and the senior Cell Therapy Leadership Team, in the advancement of quality readiness. In particular, the Sr. Dir. CT-GPQL has:Expertise in GMP compliance, global regulations, and strong understanding of pharmaceutical product development lifecycle, with specific emphasis on gene delivery and cell therapy preferred.Experience authoring, reviewing, and representing Quality in support of both clinical and commercial regulatory submissions across multiple domestic and international jurisdictions.Demonstrated decision making and problem-solving capabilities relative to Quality, compliance, technical considerations, and regulatory requirementsDemonstrated Quality leadership through partnership in a matrixed organization is requiredWorking background in Biologics, Gene Delivery, or Cell Therapy ManufacturingDemonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment Experience implementing quality strategy and standardsDirect experience participating in interactions with global regulatory agencies and in the preparation of regulatory submissionsDemonstrated ability to develop technical and strategic leadership talent to meet current and future business needsStrategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end to end enterprise) and makes the best decisions for the wholeExcellent influence and negotiation experience and capability in a matrix environmentAble to interact with senior leaders from both Cell Therapy Development and Operations and GPS in this capacity and as such is seen as a highly regarded and a credible leader with the ability to act on behalf of the ED of CTQ to interface with stakeholders in a matrix environmentThe ability to anticipate and effectively influence future trends in the industry.Additional professional and personal requirements include:Strong organizational skills, ability to multitask and work in a dynamic, fast paced environment.Experience in leading change and a demonstrated ability to accomplish results and meet deadlines and commitments.Strong collaboration, delegation and interpersonal communications skills to enable sharing critical information with project team and senior leaders.Demonstrated analytical and logical skills with a focus on fact-based decision making.Ability to build strong, trusting relationships, lead large/complex teams, and work across divisions, diverse business backgrounds and culturesExcellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organizationTravel: This role requires about 10% travel.If you want to advance 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.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.Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Bristol-Myers Squibb Company, New York , Senior Director, Global Product Quality Lead, Cell Therapy, Executive , Summit, New York