Vice President, Global Quality Control Operations & Analytical Sciences - Jobs in Brunswick

Job Description

Vice President, Global Quality Control Operationsamp; Analytical Sciences page is loaded Vice President, Global Quality Control Operationsamp; Analytical Sciences Apply locations New Brunswick - NJ - US Princeton Pike - NJ EXMFG - Dublin Boudry Devens - MA - US time type Full time posted on Posted 3 Days Ago job requisition id R1568069 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: Position Summary Reporting to the Chief Quality Officer, the Vice President, Global Quality Control and Analytical Sciences defines and shapes the Quality Control strategy for the internal and external QC Network, ensuring a high level of cGMP compliance and the safety, efficacy, and quality of all Pharma, Bio and Sterile manufactured commercial and clinical products. L eads all aspects of end-to-end QC operations, testing, and compliance for raw materials, drug substance, and drug product. Accountable for ensuring ongoing clinical and commercial testing, as well as supporting new product introductions and life cycle management to enable advancement of the pipeline, globalization and company strategy. Accountable for the development, implementation, and ongoing support of QC business systems and activities. This individual will lead our network of internal and external QC laboratories globally, and collaborate with other teams at BMS (e.g., Product Development, Manufacturing Sciences and Technology, Digital/IT, QA, Manufacturing, and Regulatory organizations) to provide strategic direction and guidance on world-class end-to-end QC operations and programs. Key Responsibilities Leads the development, direction, and execution of the Quality Control Strategy for the Bio/Sterile and Pharma Organization. Provides leadership direction for a multi-functional group of quality professionals, aligned with Quality mindset and culture that recognizes market practices and regulatory trends to achieve a uniform Quality Control strategy, as well as other Senior Quality Leaders responsible to enable quality activities critical to compliance and network related projects. Responsible for safety, compliance, strategic planning, capacity and resource analysis, equipment utilization, and ensuring consistent and harmonized day-to-day operations of BMS QC cGMP Laboratories. Establishes and oversees testing program requirements for internal and external QC testing for Analytical Chemistry, Bioassay, and Microbiology functions in support of raw material, in-process, drug substance, and finished product for overall day to day testing operations. Assists in development and implementation of appropriate policies and standard operating procedures, digital systems, laboratory data collection and documentation systems and training of personnel to ensure cGMP compliance. Oversees QC laboratory investigations, change controls, deviations including resolution of Out of Specifications (OOS) and Out of Trends (OOT) observations, and CAPAs for relevant QC operations and ensure knowledge sharing across the QC laboratory network. Provides QC support as a subject matter expert for internal and external testing sites and product related inspections (e.g., Pre-Licensing Inspection (PLI) and periodic cGMP inspections). Supports lifecycle management, globalization and CMC deliverables including content authoring and review of Quality owned sections for INDs/IMPDs, BLAs/MAAs and Health Authority information requests and communications and ensure robust analytical control strategy and data package for supporting regulatory filings. Owns and drives optimization of laboratory processes and systems to improve organization effectiveness; drives compliance at both internal and external laboratories to meet and exceed all BMS standards and global regulatory requirements Champions innovation and optimization of Global Laboratory systems including development of technology and digital roadmaps and strategic growth. Establishes and manages QC budget and maintaining control of costs; Deploys Quality Risk Management Techniques for quality oversight and problem resolution to mitigate risk in conjunction with BMS Manufacturing/Supply management and Quality. Owns the resolution of quality and technical problems within the Pharma, Bio and Sterile organization in alignment with global standards, including Internal and External manufacturing, with support from the local sites. Supports audits and Health Authority inspections for the Pharma, Bio / Sterile sites as necessary, including the assistance in the generation of HA responses and CAPAs. Ensure that the all-critical and major issues, which may have an adverse effect on the quality of the product or represent a risk of supply are escalated as per standard procedures to management and are resolved within stated timelines. Owns and drives appropriate quality governance through performance of management reviews of quality KPI’s, metrics, process performance indicators and quality system signals and supply risks. Initiate corrective actions when necessary and perform follow-up on resulting measures, with support from the local Pharma, Bio and Sterile organizations. Support local Pharma, Bio, and Serile teams to ensure that GMP follow up actions for audit/inspection o bservations are tracked and actioned as per current QMS (Quality Management System). Coordinates and/or provides SME (Subject Matter Expert) input to for BMS Policies, Directives, SOPs related to quality compliance when required. Leads communication and develops effective strategiesamp; partnership with stakeholders from Manufacturing, SB amp;E, Supply Chain, Regulatory, Project Management, and Operations. Builds strong organizational capability for current and future needs. Recruit and develop global talent to sustain local and global competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning. Develop a high-performance culture within the Quality Control organization. Coaches, leads and mentors direct reports and builds a highly capable team through the attraction, training and development of the necessary skilled professionals to meet business needs. Supports deployment of operational excellence strategies within Quality Control Network Qualificationsamp; Experience Advanced degree in science of pharmaceutical related fields (Chem, Pham, Bio, Chem Eng) preferred. Proficiency in Quality Control and Analytical processes and regulations, e.g., cGMP/GDP regulations 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 pharmaceutical and/or biological manufacturing, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes.gt;15 years of experience managing Quality and Compliance organizations. 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. Has a proven record of accomplishment of delivering results, is action oriented and has worked directly with Compliance remediation activities as a result of regulatory actions. Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the overall business (end to end enterprise) and makes the best decisions for 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 GQ (Internal Sites) and interface with stakeholders in a highly matrixed 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. 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 advocate: appropriately evaluates tradeoffs to make bold decisions that are in the best interest of BMS and of our patients; understanding the bigger picture beyond own functional area, seeks to have an impact on organization wide performance; embrace complexity but strive for simplicity External mastery: constantly looks outside the organization to understand customer needs, competitors and global trends and uses the data to achieve a competitive advantage for BMS Change Activator: Relentlessly identifies and creates game-changing opportunities that lead to higher organization performance and influences others to do the same Courageous Innovator: stretches beyond the expected to succeed in a rapidly evolving, strategic and transformational environment Authentic Leadership: Demonstrates an honest and unbiased understanding of their own strengths, limitations, and values; lives up to their principles and conviction without being rigid or dogmatic; generates trust by maintaining the highest level of consistency between their words and their actions. Talent Developer; proactively develops talent for the long and short-term, both within and outside their team. 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. COVID-19 Information 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. 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 . Visit 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. Similar Jobs (1) Vice President, Corporate Quality locations 5 Locations time type Full time posted on Posted 3 Days Ago About Us Data Privacy Link W e’re creatinginnovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.