Quality Director, Drug Substance, External Manufacturing

Working with Us Challenging. Meaningful. Life-changing. Those aren’t 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. You’ll 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. Bristol Myers Squibb Ireland Bristol Myers Squibb is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases in areas including oncology, haematology, immunology, cardiovascular and neuroscience. Our employees work every day to transform patients’ lives through science. Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units. Many of the global business services, including the European Treasury Centre, Market Supply Operations and Commercial Operations have a presence in Ireland. Ireland is also home to External manufacturing’s global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO’s) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network. Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus. For more information about Bristol Myers Squibb, visit us at BMS.com/ie The Role Bristol Myers Squibb is looking to recruit a permanent Quality Director, Drug Substance, External Manufacturing to join our ExM team in Dublin or Boudry. The Drug Substance Quality Operations Director, External Manufacturing Quality, provides Quality Leadership to ExM Bio/Sterile across all Biologic Drug Substance CMOs. The incumbent leads a global team with compliance and quality oversight responsibility across the external DS network. Builds relationships with contract manufacturers through the Virtual Plant Team governances and proactively manage and improve CMO Quality performance through risk-based oversight and periodic reviews. This leader also leads strategic compliance projects and initiatives at CMOs to ensure a high level of cGMP compliance and the safety, efficacy and quality of externally manufactured commercial Bio&Sterile drug products. Implements effective CMO trending processes to ensure proactive signal detection. Ensures regulatory compliance at CMO operations & embeds regulatory surveillance. Drives significant impact to current and future business performance though building a functionally excellent infrastructure (knowledge, processes and systems) to handle complex quality and compliance responsibilities. Works closely with the Business and MS&T leads to drive strategic change and value. This position will requires ~25% travel Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs Key Duties and Responsibilities: Leads a global team with compliance and quality oversight responsibility across the external drug substance CMO network Supports Strategic Partnership initiatives Deploys Quality Risk Management Techniques for quality oversight and problem resolution for CMOs to mitigate unacceptable risk in conjunction with BMS Manufacturing/Supply management and Quality. Leads the development of risk registers for Bio/Sterile Ensures CMOs & BMS are inspection ready (including PAI). Supports audits and Health Authority inspection for the CMOs as necessary, including the assistance in the generation of HA responses and CAPAs. Assure appropriate quality governance through performance management reviews of quality KPI’s, metrics, process performance indicators and quality system signals and EXM CMO supply risks. Initiate corrective actions when necessary and perform follow-up on resulting measures. Provide support for authoring and review of CMC filings Ensure that GMP follow up actions for audit/inspection observations are tracked and actioned as per current QMS – and implements trending processes Leads Compliance projects and initiatives for the External Manufacturing Bio/Sterile and broader Quality Organization. Builds strong organizational capability for current and future needs. Supports deployment of operational excellence strategies within EXMQ and drives continuous improvement efforts in key Quality and Compliance processes Provides oversight and resourcing where applicable within the ExMQ organization for projects (transfers, launches, due-diligence, other) – providing support where needed to ensure compliance with the QMS, and to facilitate issues escalation and resolution. Supports Digital and Automation strategies at CMOs Leads communication and develops effective strategies & partnership with stakeholders from MS&T, OpEx, Supply Chain, Regulatory, Project Management, and Operations. Coordinates and/or provides SME input to for BMS Policies, Directives, SOPs related to quality compliance when required. Ensures all aspects of Quality Management of Biologic External Supplier/CMO is carried out according to the standards defined and is regularly reported and assessed for adequacy of performance. Qualifications, Knowledge and Skills Required: Advanced degree in science of pharmaceutical related fields (Chem, Pham, Bio, Chem Eng) preferred. >15 years of experience managing Quality and Regulatory/Compliance organizations. Mastery of Quality compliance processes and regulations, e.g., cGMP/GDP regulations for External Manufacturing QA. Direct experience with Global health authorities and managing inspections A thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality investigations. Thorough understanding of technical areas related to biological and pharmaceutical manufacturing, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes. Ability to assess the right balance between business targets and scientific and quality decisions. Able to understand the business implications regarding quality positions and decisions. Ability to enforce quality decisions at external manufacturers Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization. Excellent influencing and negotiating experience and capabilities in a matrix environment. Must be able to interact with senior leaders 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 Exec Dir ExM Quality and interface with stakeholders in a matrix environment. Uses judgment to make sound decisions based on information gathered and analyzed. Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures. Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness. Has a proven track record of delivering results and is action oriented. Adapts to changing work environments, work priorities and organizational needs. Plans and organizes tasks and work responsibilities to achieve objectives. Sets priorities. Schedules activities. Enterprise Mindset Understands the big picture, beyond their own functional area. Leads within the broader internal and external network, and seeks to have impact on organization-wide performance. Embraces complexity, but strives for simplicity. Change Agility Translates the case for change into actionable plans for the organization. Demonstrates smart risk-taking and personal resilience when implementing change. Enables others to navigate change with confidence and in sustainable ways. Talent Developer Coaches and mentors team and proficiency in talent development What’s important to us Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases: Passion: Our dedication to learning and excellence helps us to deliver exceptional results. Innovation: We pursue disruptive and bold solutions for patients. Urgency: We move together with speed and quality because patients are waiting. Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments. Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues. Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential. We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve. Why you should apply You will help patients in their fight against serious diseases You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. You’ll get a competitive salary and a great benefits package BMSBL
LI-Hybrid If you come across a role that intrigues you but doesn’t 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 perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.