Product Owner jobs at Sanofi US

Scrum Master job responsibilities include: Facilitating Scrum ceremonies such as daily stand-ups, sprint planning, and retrospectives Identifying and removing obstacles hindering team progress Coaching teams on self-organization and Agile practices Communicating project status, risks, and issues to stakeholders Project Manager Technical Experience a Plus to have Promoting continuous improvement through feedback and retrospectives Desired Qualifications: Bachelor's degree in computer science, Business, or a related field 10+ years of experience as a Scrum Master Strong knowledge of Agile methodologies and Scrum framework Excellent communication and leadership skills Experience working with cross-functional teams in a fast-paced environment.

ABOUT THE ROLE The eCommerce Manager will be responsible for taking end-to-end operational and strategic ownership of our Direct-to-Consumer (“DTC”) sales across our digital storefronts included but not limited to Amazon (Seller/Vendor Central) and Shopify. YOUR GOAL Achieve or exceed quarterly sales and profitability targets across assigned digital storefronts Improve profitability year over year through pricing, cost and advertising optimizations Maintain 100% account health compliance on Amazon and 100% site uptime and functionality on Shopify Launch all new products on time and achieve minimum first-quarter sales targets per launch plan Improve listing conversion rates within the first six months through CRO testing and content enhancements YOUR KEY RESPONSIBILITIES Drive strategic sales growth across our digital storefronts by developing forecasts, managing budgets, and optimizing pricing, promotions and profitability across all stock keeping units (“SKUs”) Lead new product launches and competitive strategies, identifying market opportunities and executing rollout plans that align with revenue and margin goals Execute and optimize all eCommerce operations across Amazon and Shopify, including advanced advertising tactics, conversion rate testing, inventory forecasting and search visibility to maximize performance and sales growth Oversee site experience, reporting, and compliance across Amazon and Shopify, use performance data to optimize site merchandising, maintain account health and increase conversion through client review strategies Perform other reasonable duties as required to assist the department and the company in achieving its goals and objectives YOUR QUALIFICATIONS Minimum ten (10) years of hands-on experience managing and optimizing high-growth eCommerce operations, with expert-level proficiency in both Amazon Seller/Vendor Central and Shopify platforms Proven success as a high-impact individual contributor who has directly managed and scaled annual revenue exceeding eight figures in a DTC Expertise in advanced digital advertising across Amazon Ads (including delivery service partner (“DSP”)), Google Analytics, and paid social channels Advanced proficiency in Excel/Sheets for forecasting and profitability analysis YOUR SKILLS Exceptional analytical and quantitative skills Excellent organizational and project management and prioritization skills Exceptional communication and collaboration abilities. Strong attention to detail and commitment to quality control. Adaptability to shifting priorities and fast-paced timelines. Results-oriented with integrity and accountability Proficiency with Microsoft Office Suite (or equivalent tools)

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. You will make an impact: At eClinical Solutions, our goal is to empower life sciences organizations around the world to manage and analyze clinical data more efficiently through an AI-first approach. We are looking for a Product Owner who will play a key role in translating customer and business needs into actionable user stories that guide the development of the elluminate platform. You will be a champion of user value and data-driven design, working closely with product managers, engineers, UX designers, and clinical domain experts to shape high-impact product features. This role is ideal for someone who is detail-oriented, passionate about user experience, and thrives in a collaborative, fast-paced agile environment. Your day to day: Translate Strategy into Execution Partner with product managers and stakeholders to break down high-level product strategies into clear, detailed epics and user stories Serve as the voice of the customer in agile ceremonies, ensuring the team is always aligned on delivering business and user value Support creation of wireframes and prototypes to visualize workflows and improve user experience Collaborate with engineering and UX teams to refine requirements, review prototypes, and validate deliverables throughout the sprint cycle Facilitate Agile Collaboration Participate in all agile rituals, including sprint planning, backlog grooming, reviews, and daily standups Maintain a well-prioritized product backlog, ensuring clarity, consistency, and alignment with roadmap goals Collaborate cross-functionally with QA, documentation, services, and support teams to ensure successful product releases Contribute to Market & Domain Intelligence Research and document industry trends, competitive offerings, and evolving customer needs Stay informed on clinical trial standards, data workflows, and regulatory requirements Contribute to knowledge sharing across the organization through release notes, internal trainings, and support materials Education & Experience Bachelor's degree in a life sciences discipline, computer science, or related field, or equivalent work experience preferred 5+ years of experience in a product owner, business analyst, or clinical data role within life sciences technology or clinical trials preferred Hands-on experience with agile product development processes and tools (e.g., Jira, Confluence, ProductBoard) Prior experience working on a cloud-based SaaS platform strongly preferred Professional Skills Strong understanding of product development lifecycle and user-centered design principles Proven ability to write clear, concise user stories and acceptance criteria Excellent communication and interpersonal skills; comfortable presenting ideas and facilitating cross-team discussions Highly organized with strong attention to detail and the ability to manage multiple priorities Curious, analytical mindset with a passion for solving real-world problems in clinical research Technical & Domain Skills Familiarity with clinical trial workflows, EDC systems, and regulatory standards (e.g., CDISC, 21 CFR Part 11, IHC E6) is a plus Experience creating or reviewing clinical metadata and working with data visualization tools is desirable Working knowledge of agile methodologies and best practices for backlog management Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical is a winner of the 2023 Top Workplaces USA national award! We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience. See all the details here: ****************************************************** eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need. #LI-AB1 Pay Range US Pay Ranges $100,000-$120,000 USD

Company Navitus About Us Navitus - Putting People First in Pharmacy - Navitus was founded as an alternative to traditional pharmacy benefit manager (PBM) models. We are committed to removing cost from the drug supply chain to make medications more affordable for the people who need them. At Navitus, our team members work in an environment that celebrates diversity, fosters creativity and encourages growth. We welcome new ideas and share a passion for excellent service to our customers and each other._____________________________________________________________________________________________________________________________________________________________________________________________________________. Current associates must use SSO login option at ************************************ to be considered for internal opportunities. Pay Range USD $105,271.00 - USD $131,588.00 /Yr. STAR Bonus % (At Risk Maximum) 5.00 - Salaried Non-Management except pharmacists Work Schedule Description (e.g. M-F 8am to 5pm) M-F 8am to 5pm, CT Remote Work Notification ATTENTION: Navitus is unable to offer remote work to residents of Alaska, Hawaii, Maine, Mississippi, New Hampshire, New Mexico, North Dakota, Rhode Island, South Carolina, South Dakota, West Virginia, and Wyoming. Overview Navitus Health Solutions is seeking a Sr. Product Owner, IT to join our team! We are seeking an enthusiastic, driven person to collaborate and facilitate value delivery. As a Product Owner you will play a critical role in partnering with Business Leads and the Portfolio to define, prioritize, and drive the development of product enhancements and large strategic initiatives. The Product Owner will work closely with a cross functional team to ensure that the value delivery aligns with the overall business objectives and meets customer needs. Is this you? Find out more below! Responsibilities How do I make an impact on my team? • Deep focus on execution, follow-through, accountability, and results• Work closely with Business Leads on Product Vision and Strategy that aligns with overall company goals and strategy. • Create user stories, features and other documentation to communicate business/technical needs to the development team.• Work closely with the team to agree on the completion of accepted stories to ensure they meet the definition of done and meet quality standards.• Work with the development team, participate in PI Planning, Sprint Planning, Daily Stand-up, and Sprint Reviews. • Provide leadership, clarification, and subject matter expertise. • Responsible for continuously refining and maintaining the team backlog with updates from Business Leads, the Portfolio, and the team. • Lead, develop and mentor other Product Owners.• Other duties as assigned Qualifications What our team expects from you? • Bachelor's degree in business or information systems, or other relevant technical field of study, or equivalent work experience required.• Product Owner, Product Manager, or Scrum Master certification required. POPM or SPC certification preferred. • 7+ years of experience as a Business Analyst, Product Owner, Product Manager, or Scrum Master required.• 3+ years working on large scale corporate initiatives that span multiple product teams required.• Understanding of agile at scale philosophies or methodologies required.• Experience with ALM tools such as Jira, VersionOne, Rally, Azure DevOps required.• Experience working in Healthcare or PBM preferred.• Experience in a scaling agile preferred.• Agile Transformation preferred.• Participate in, adhere to, and support compliance program objectives • The ability to consistently interact cooperatively and respectfully with other employees What can you expect from Navitus? Top of the industry benefits for Health, Dental, and Vision insurance 20 days paid time off 4 weeks paid parental leave 9 paid holidays 401K company match of up to 5% - No vesting requirement Adoption Assistance Program Flexible Spending Account Educational Assistance Plan and Professional Membership assistance Referral Bonus Program - up to $750! #LI-Remote Location : Address Remote Location : Country US

COMPANY BACKGROUND We are the fourth largest full service laboratory in the United States, primarily a clinical testing laboratory servicing physician offices with concentrations in the focused markets of esoteric testing, molecular diagnostics, anatomical pathology, women's health and correctional health care. Our oncology lab is one of the premier hematopathology laboratories in the country and its GenPath Women's Health is a national presence in Women's Health testing. The genetics laboratory, GeneDx, is typically recognized as the leading laboratory for testing of rare genetic diseases; having been the first commercial laboratory to utilize next generation sequencing technologies to answer meaningful clinical questions in cardiology, neurology and ophthalmology, among other clinical areas. GeneDx has once again earned its leading position with XomeDx, whole exome sequencing test. We are constantly looking for new technologies and new methodologies that will help the company grow. People are the most valued asset driving advances in technology and diagnostic methodologies. POSITION SUMMARY We are currently recruiting for a Digital Product Owner based out of its corporate headquarters in Elmwood Park, NJ. Additionally, the manager will work closely with the CIO, key stakeholders, the PMO, and IT leaders on prioritizing IT programs and projects to ensure alignment with the general goals and objectives for the company. PRINCIPAL JOB DUTIES Duties may include but are not necessarily limited to the following: * Represents the business community * Ensures value delivery * Acts as a voice of the customer * Drives definition and design for new functionality, which includes writing user stories, breaking down large stories, and specifying acceptance criteria * Providing vision and direction to the Agile development team and stakeholders throughout the project and create requirements * Ensure that the team always has an adequate amount of prior prepared tasks to work on * Plan, prioritize and groom product feature backlog * Execute plan and prioritization of development for the product, while exercising release planning * Define product vision, roadmap and growth opportunities * Assess value, develop cases, and prioritize stories, epics and themes to ensure work focuses on those with maximum value that are aligned with product strategy * Provide backlog management, iteration planning, and elaboration of the user stories * Work closely with Product Management and Business Stakeholders to create and maintain a product backlog according to business value or return on investment * Lead the planning product release plans and set expectation for delivery of new functionalities * Provide an active role in mitigating impediments impacting successful team completion of Release/Sprint Goals * Research and analyze similar products, the users, and the roadmap for the product * Other duties as assigned EDUCATION BS degree in computer science, business, management information systems, or related field EXPERIENCE AND REQUIRED SKILLS * 5-7 years with product ownership or product management in agile/waterfall software development. Healthcare industry a plus. Strong design-centered thinking. * Ability to connect with all stakeholders and deliver expected results * Outstanding communication, presentation and leadership skills * Excellent organizational and time management skills * Sharp analytical and problem-solving skills * Creative thinker with a vision and ability to improve user experience through effective functionality and UI design * Working experience with roadmaps and deployments of production applications, including in-house applications and public facing websites. * Strong communication and presentation skills (oral and written) to shape messages to the appropriate level of audience * Advanced skills preparing and presenting product roadmap * Ability to understand complex business flows

Requisition ID: 63705 Title: Clinical Product Manager - Global Endoscopy Division: Arthrex, Inc. (US01) Location: Remote Salary Range: Salary Minimum: $94,500 Salary Maximum: $170,000 This position is remote, with travel primarily to West Coast. The ideal candidate will be based in the Western US. Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Clinical Product Manager to manage and lead our initiatives within the Global Endoscopy portfolio. The successful candidate will build relationships with key customers and internal departments to help drive new product innovation and manage product lines. Excellent interpersonal and leadership skills along with a Bachelor's degree and five years of experience are essential for this position. The position is remote to be based in our West coast or Northeast regions and does require frequent travel. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better. Main Objective: The Clinical Product Manager will be responsible for overseeing and managing the Multi-specialty imaging solution - focusing on fluorescence and additional visualization modalities sales opportunities, performance, training, and other activities with the sales force, surgeons, and accounts within his/her respective region. In addition, candidate is expected to forge new relationships with bio science partners focused on advanced visualization. Essential Duties and Responsibilities: * Ensure all IR Managers are trained to a high standard on anatomy, procedures and fluorescence science. * Manage clinical studies/research papers related to fluorescence imaging. * Assist IR Managers, Capital Managers & representatives with evaluation and closing activities with key customers and reporting back to Imaging and Resection Managers as it relates to advanced visualization. * Training representatives on advanced visualization and fluorescence solutions and sales cycle as needed. * Assist Imaging and Resection Sales Management in implementing sales playbook and execution of strategy. * Lead interaction with General, Urology, GYN, ENT and Thoracic surgeons to expand brand awareness of the Synergy solutions. Assist Ortho surgeons in fluorescence imaging discovery. * Manage entire sales pipeline to monitor health of the business and maximize closure rate and success. * Communicate sales opportunities to the Director - Global Endoscopy, Imaging and Resection Sales Management and Product Management. * Communicating product attributes and shortcomings to product managers and recommending product line enhancements. * Collecting key competitive information and ensuring that knowledge drives both sales effectiveness and product development direction. * Coaching, teaching, and when necessary directing opportunities to via conference calls and in person visits on products/sales strategy/competitive info. * Engage current and identify new Key Opinion Leaders for Local, Regional, and national peer to peer interactions. * Lead the submittal of RFP and tender responses working with regional and agency sales managers. * Up to 60% Travel. Education and Experience: * Bachelors degree required; MBA preferred. * Five years medical device sales or product management experience required, preferably in laparoscopic surgery. * Experience in the field with Endoscopy insufflation and fluorescence in Sales/Marketing required. * Experience at C-Suite level negotiations required. Knowledge and Skill Requirements/Specialized Courses and/or Training: * Willing to travel up to 60 % to sales presentations, trials, evaluations, demos, tradeshows, and customer meetings. * Knowledge of advanced surgical video and integration. * Skilled in working with different functions and effectively coordinates their activities to achieve desired results. * Excellent listening skills, including the ability to identify and isolate customers concerns or objections, in addition to excellent written and oral communication skills. * Strong relationship building skills desired. Arthrex Benefits * Medical, Dental and Vision Insurance * Company-Provided Life Insurance * Voluntary Life Insurance * Flexible Spending Account (FSA) * Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) * Matching 401(k) Retirement Plan * Annual Bonus * Wellness Incentive Program * Gym Reimbursement Program * Tuition Reimbursement Program * Trip of a Lifetime * Paid Parental Leave * Paid Time Off * Volunteer PTO * Employee Assistance Provider (EAP) All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law. Making People Better at Arthrex Lorem ipsum dolor sit amet consectetur. Cras fringilla elementum odio velit. Job Details Date: Nov 16, 2025 Requisition ID: 63705 Salary Range: Job title: Clinical Product Manager - Global Endoscopy Arthrex Location: Remote, US, 34108 Nearest Major Market: Naples Job Segment: Clinic, Gastroenterology, Orthopedic, Product Manager, Healthcare, Operations, Marketing

Key Role Requirements: Certifications: CSPO, SAFe PO, CBAP, AAC, CPOA or equivalent certification Experience as a full-time business analyst or product owner and able to operate in both waterfall & agile environments with a sense of urgency. Ability to create standards, frameworks and processes for IT compliance group for both waterfall & agile projects as well as production support requests. Ability to ideate, identify, document, prioritize and groom requirements/user stories with acceptance criteria and documenting key decisions. Ability to perform some scrum duties, as needed

The Agile Product Owner role will groom the team's backlog, answers the team's questions about requirements, has discussions with stakeholders, and accepts content from the team. They will work with the team daily to make sure the content in the sprint sees completion.

The ideal candidate will have: Product management experience with maintaining and prioritizing a product backlog Data, reporting or analytics experience in a large enterprise Business process acumen and ability to map process to a technology solution Experience working as a member of a larger cross-functional Agile team. Design and implement features in collaboration with business partners and engineers using Agile / Scrum methodology Ability to define source to target mapping, functional specifications and other documentation

Lead Data BSA Enterprise Data and Analytics NIKE, Inc. does more than outfit the world's best athletes. It is a place to explore potential, obliterate boundaries and push out the edges of what can be. The company looks for people who can grow, think, dream and create. Its culture thrives by embracing diversity and rewarding imagination. The brand seeks achievers, leaders and visionaries. At Nike, its about each person bringing skills and passion to a challenging and constantly evolving game. Nike is a technology company. From our flagship website and five-star mobile apps to developing products, managing big data and providing leading edge engineering and systems support, our teams at NIKE Global Technology exist to revolutionize the future at the confluence of tech and sport. We invest and develop advances in technology and employ the most creative people in the world, and then give them the support to constantly innovate, iterate and serve consumers more directly and personally. Our teams are innovative, diverse, multidisciplinary and collaborative, taking technology into the future and bringing the world with it. Nikes Enterprise Data & Analytics organization is redefining how data is gathered, run, governed, and unlocked, making it Available, Consistent, and Trusted to drive Nikes business! The Transactional Data Products team needs a Lead Data Business Systems Analyst to deliver Inventory and Logistics Data Products. As a Lead Data Business Systems Analyst on the Transactional Data Products team, you will drive the ingestion and integration of sales and demand data, leveraged by Business Intelligence and Advanced Analytics teams to gain insights on Nikes successes and opportunities. You will propel analytics through robust data comprehension, data modeling, and cross-functional partnerships. A successful candidate in this diverse role, will have a potential focus ranging from: (1) data architecture design to direct business process evolution, (2) reverse engineering existing solutions to understand and evolve the process, (3) researching a critical source system/service to automate ingestion, and (4) educating teammates on your robust knowledge of business data requirements and data movement. This role will be vital in shaping the landscape by which analytics teams interact with and leverage data, as each release broadens available data sets and expands analytics self-serve capabilities. Experience in inventory and logistics systems is preferred. RESPONSIBILITIES We are seeking a high performing Lead Data BSA to play a key role in the development of transcational data products You will work with a variety of talented teammates including data engineers with a focus on the design and development of new solutions and capabilities for Nikes supply chain analytics and data platforms. The successful candidate is a problem solver with excellent business acumen, knowledge and understanding of enterprise data and analytics systems, with hands-on coding skills. Proven ability to sift through data, identify critical information, analyze, and develop solution options In this role, you will be responsible for designing innovative, high quality, cloud based analytics solutions and capabilities in support of the supply chain. Work directly with customers and team members to capture details of epic and story requirements, understand use cases, collect samples, and create tests; apply knowledge of Product and business drivers to enhance work

Responsibilities Drive the creation of new technical personalization capabilities to be developed and tested through scalable frameworks Lay the technical foundation to use state-of-the-art approaches to personalized user experiences Validate product and technology hypotheses in the space of personalization and relevance Understands the complexities of building ML and NLP products; has experience prototyping, iterating on, evaluating and scaling large-scale ML/NLP systems; can connect ML value propositions to actual user problems. Can visualize how a strong technology platform would enable personalization

Product owner for Loss Prevention exception-based reporting tool and retail back end systems. Working with solutions across the globe that aid our retail teams in finding and preventing fraud.

6 months (with probability of extension) Bridgewater, NJ (hybrid 50% minimum onsite) Context Experienced Scrum Master: Digital Risk & Compliance The Digital Risk & Compliance (DRC) function is currently in the middle of a change program to transform from a largely Quality Control focused approach to managing risk and compliance topics in Digital/IT to one that is based on empowering Digital/IT teams to be accountable for the risk management and compliance of their solutions through a combination of advisory capabilities, process changes, automation & self-service offerings. Mid-July we have released an MVP and are now refining our roadmap to deliver further iterations and increments in an Agile, Product-oriented approach. To do this successfully, we will need to build and mature an Agile approach that fits this type of complex organizational change effort. Requirements Scope of the Role · As part of the Strategy & Governance team in DRC, work closely with the Head of the team, a junior Scrum Master and an Agile Coach to define the Agile delivery approach and required tooling. · Serve as the Scrum Master across several product delivery teams (Scrum teams) to support the development of the next increments while maturing the approach and establishing the required ceremonies. · Work closely with the Product Owner and component owners to build a robust product backlog and appropriate practices to manage it across the different teams, including assisting the Product Owner to effectively collect customer feedback. · Support the upskilling of the internal, junior Scrum Master by working alongside her and coaching her. Required Experience & Skills · Advanced Scrum Master certification with 5+ years supporting scrum and scaled scrum teams to deliver complex products · Ideally Agile coaching experience · Experience beyond Software Agile projects, but including change initiatives like our Transformation program, combining operating model, process and tool/software components

Citco is a global leader in fund services, corporate governance and related asset services with staff across 50 office locations worldwide. With more than $2 trillion in assets under administration, we deliver end-to-end solutions and exceptional service to meet our clients' needs. For more information about Citco, please visit ************* About the Team & Business Line: Proprietary software solutions and innovation are at the core of what differentiates Citco in the alternative investment space. Through our network of global development centers, Citco invests heavily in technology development, security, and infrastructure to ensure our clients continue to receive award-winning products that underpin our commitment to service excellence. As a core member of our IT Governance (IT-GOV) team, you will join a global organization that is transforming how we deliver value to our stakeholders. We are moving beyond traditional project delivery to embrace modern value stream thinking and flow-based delivery methods. This evolution requires experienced leaders who can drive organizational change while maintaining delivery excellence. Reporting to the IT Program Manager, you will play a pivotal role in evolving our delivery framework and cultivating a culture of continuous improvement. As an experienced agile leader, you will guide multiple teams across our technology landscape using modern value delivery practices, balancing strategic leadership with hands-on team facilitation. This role requires someone who can both shape and implement our future-state delivery vision while driving organizational agility and innovation. The ideal candidate brings extensive experience in complex, enterprise-level environments, demonstrating a strong track record of leading high-performing agile teams, excellence in stakeholder management, and deep understanding of value stream optimization. Your background should showcase exceptional adaptability, strategic thinking, and interpersonal skills, complemented by demonstrated expertise in leading large-scale agile transformations and driving measurable delivery improvements. This role offers the opportunity to shape how Citco delivers value while working with cutting-edge technologies in a dynamic, global environment. Your Role: As a Senior Scrum Master, you will focus on the following key areas: * Value Stream Leadership * Champion value-driven delivery practices across multiple teams * Design and implement value stream mapping and optimization strategies * Establish and monitor flow metrics (lead time, cycle time, flow efficiency) * Guide teams in WIP management and pull-based systems * Break down organizational silos and promote cross-team collaboration * Ceremony Facilitation & Team Enablement * Lead high-impact ceremonies across multiple teams (stand-ups, reviews, retrospectives) * Facilitate release planning and story mapping sessions * Guide sprint planning and backlog refinement activities * Support teams in defining their Definition of Done * Enable effective Scrum of Scrums coordination * Flow Optimization & Metrics Management * Implement and optimize flow-based delivery methods using Jira * Configure advanced Jira workflows aligned with value stream practices * Create and maintain comprehensive dashboards for: * Value stream visualization * Flow metrics (WIP, cycle time, lead time) * Impediment and dependency tracking * Team performance metrics * Portfolio-level progress * Guide teams in: * Queue management and flow optimization * Establish WIP limits and bottleneck resolution processes * Drive data-driven improvement initiatives through: * Automated metrics collection * Value-focused status reporting * Trend analysis and forecasting * Establish and maintain end-to-end visibility of work across the SDLC * Coaching & Mentorship * Mentor junior Scrum Masters and team members * Coach teams in agile principles and self-organization * Guide teams in establishing sustainable delivery practices * Promote knowledge sharing and cross-skilling * Foster a culture of continuous learning * Stakeholder Management * Work closely with Product/Platform Owners and business stakeholders * Manage senior leadership expectations and reporting * Facilitate cross-functional alignment and communication * Lead stakeholder alignment meetings * Manage cross-team dependencies and remove impediments * Drive organizational change initiatives * Technical Excellence * Support DevOps and CI/CD adoption * Promote quality-focused development practices * Enable automated testing implementation * Guide teams in technical debt management * Facilitate innovation and experimentation About You: * Leadership & Transformation Experience * 7+ years of IT delivery experience, with 5+ years in Scrum Master roles * Proven track record leading multiple agile teams in complex environments * Demonstrated experience implementing value stream management practices * Strong history of mentoring junior Scrum Masters and delivery teams * Experience driving organizational change and agile transformation * Financial services industry experience strongly preferred * Certifications & Education * Advanced Scrum Master certification required (PSM II, CSP-SM, or equivalent) * Scaled Agile certification required (SAFe SPC, LeSS Practitioner, or equivalent) * Value Stream Management certification preferred * Bachelor's degree in computer science, Information Systems, or related field * Continuous learning mindset with commitment to professional development * Technical Excellence * Expert-level proficiency in enterprise agile tools (Jira, Confluence, Portfolio Management) * Strong understanding of DevOps practices and CI/CD principles * Experience implementing flow metrics and value stream analytics * Knowledge of Cloud Service Providers * Proven ability to guide teams in technical practice improvement * Delivery Capabilities * Demonstrated success in implementing flow-based delivery methods * Experience with value stream mapping and optimization * Strong track record of removing organizational impediments * Expertise in scaled agile frameworks and practices * Proven ability to drive measurable delivery improvements * Essential Skills * Outstanding stakeholder management and communication abilities * Strong analytical and problem-solving capabilities * Excellence in coaching and mentoring * Proven negotiation and conflict resolution skills * Ability to influence without direct authority * Strategic thinking with practical execution focus * Professional Attributes & Additional Requirements * Natural leader with strong presence and credibility * Change agent with proven transformation experience * Results-oriented with focus on business outcomes * Collaborative approach to team and organizational development * Resilient and adaptable in fast-paced environments * Availability to travel occasionally to other Citco locations (10%) * Experience working in regulated environments * Strong understanding of risk management principles * Excellent written and verbal communication skills in English The ideal candidate will demonstrate both strategic vision and hands-on capability, with a proven track record of implementing value-driven delivery practices while maintaining strong stakeholder relationships at all organizational levels. Our Benefits Your well-being is of paramount importance and central to our success here at Citco. Citco offers a comprehensive and competitive total rewards package to support your career success and personal needs. Your base salary will be determined by several factors such as the role, experience, skillset, market conditions, etc. Furthermore, qualifying positions can participate in an annual discretionary bonus pool based on company profitability and individual contributions. Our comprehensive benefits package includes medical, dental, and vision coverage, short and long-term disability benefits, a retirement savings plan, tuition reimbursement, mental health and wellness support, parental leave, and more. Additional details about our total rewards package will be shared during the hiring process. At Citco, we take pride in fostering an inclusive culture by prioritizing the hiring of people from diverse backgrounds. Our culture is a source of pride and strength, fostering innovation, mutual respect, and collaboration. We warmly welcome and encourage applications from people with disabilities. If you require any accommodation to make our recruitment process more accessible for you, please let your recruiter know. As an equal opportunity employer, Citco adheres to making all employment and personnel decisions without discriminating based on race, color, creed, religion, sex, physical disability, mental disability, age, marital status, sexual orientation, citizenship status, national or ethnic origin, or any other protected status. We believe that an inclusive workforce not only enriches our company but also drives us towards greater success. Please note that this job description is not intended to be all-inclusive. Our employees may perform other job-related duties as needed to meet the ongoing needs of our organization.

SummaryJob Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health ™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. About the role: In this role you will partner with the product owner on projects, and the overall cross-functional team, to support the successful global launch of a key initiative for bdbiosciences.com. You will lead projects aimed at improving customer experience through the eBusiness channel including web, e-commerce, B2B, punchout and other digital channels. You will also support the team that leads multiple related but distinct projects, with members of marketing, IT, shared services (legal, regulatory, etc.), and external vendors to ensure seamless execution of all phases through launch. Key responsibilities include: Works with product owner and other functional leaders to ensure the appropriate core team resources and the external strategic partners are committed to the projects and supply to the expected levels. Develops detailed program/project execution plan, and manages implementation processes including financials, progress tracking, metrics, monitoring change control process, testing, release to production and on-time delivery within budget constraints. Provides overall communication and works with all areas affected by the program/project. Drives the team to project completion ensuring that we are creating best-in-class product and service experiences. Coordinates cross-team dependencies or participate in Scrum of Scrums, if applicable. Provides regular status updates, dashboards, and reports to leadership. Improves project workflows, documentation, and team productivity. Identifies opportunities for automation, process optimization, and better team coordination. Facilitates all scrum ceremonies: Daily Stand-ups, Sprint Planning, Sprint Review, and Sprint Retrospective. Ensures Scrum events are efficient, valuable and time-boxed. Facilitates coordinate and track UAT for major enhancements and projects. Builds a safe and trustful environment with an emphasis on problem-solving and psychological safety. About you: To succeed in this role, someone needs to be highly organized and skilled at managing complex projects across multiple teams, with strong communication and collaboration abilities. They should be comfortable working in an Agile environment as a Scrum Master, able to remove obstacles, keep projects on track, and ensure seamless execution. A focus on customer experience and digital solutions is essential, along with adaptability to handle competing priorities in a fast-paced global setting. Required education and experience Bachelor's degree in computer science, Engineering, Information Systems, or related field First or second level Scrum Master (CSM, ACSM, PSM I/II) or Certified Scrum Professional (CSP) At least 4 years of experience in technical project management, program management, or related technical roles Expert-level knowledge of JIRA and Confluence, with the ability to customize them based on project needs Experience working with Agile, Scrum, or Kanban methodologies. Experience with Agile traits and techniques: Lean design, accommodating changing requirements, iterations, loop feedback with customer involvement. Demonstrated consistent ability to lead cross-functional teams and deliver technical solutions while mitigating or removing hurdles / obstacles. Proven a track record of overcoming project crisis. Ability to lead cross-functional leadership in a global, fast-paced, matrix organization. Strong analytical and problem-solving skills. Preferred qualifications: Ecommerce experience highly preferred Technical knowledge preferred At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. --- Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of our health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA CA - Milpitas 155Additional LocationsWork Shift At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

We are seeking a Senior Technical Product Lead to drive product and project leadership within a drug product contract manufacturing organization (CMO). This role supports programs from initial facility fit assessment and technology transfer through client interaction, process improvements, validation, and commercial manufacturing. The Technical Product Lead will be part of the MS&T (Manufacturing Science & Technology) group, leading client interactions, internal project management, and technical and business process improvements. This position is fully on-site at our facility in Costa Mesa, CA. Key Responsibilities: New Product Introduction: Lead and contribute to proposal writing and review. Conduct facility fit assessments for new manufacturing programs, including risk assessments, failure mode analyses, and process impact evaluations. Oversee technology transfer activities between development and manufacturing. Translate process development reports into manufacturing batch records and SOPs. Provide hands-on manufacturing process training as part of technology transfer. Project Management: Develop and lead process improvement projects. Implement systems for improved GMP planning, scheduling, and execution. Oversee the lifecycle management of clinical and commercial programs. Develop and manage comprehensive project plans, sharing key deliverables with internal and external stakeholders. Serve as a primary client liaison, ensuring high-quality contract manufacturing services. Act as a technical interface between internal teams and client partners. Quality & Compliance: Support root cause investigations and CAPA (Corrective and Preventive Actions) implementation. Author and manage change control for internal and client-related projects. Drive operational excellence in collaboration with Manufacturing by identifying and implementing process improvements. Qualifications: Bachelor's Degree in Sciences or Engineering or equivalent experience. 8 years of experience supporting biotech or pharmaceutical manufacturing operations. Experience with aseptic operations and drug product manufacturing is required. 5 years of experience in project management within a biotech, pharmaceutical, or CMO setting. Strong understanding of GMP regulations and compliance within manufacturing facilities. Ability to analyze and improve manufacturing process data. Excellent written and verbal communication skills (technical writing ability required). Ability to work cross-functionally within internal and external teams to drive project success. Self-motivated, adaptable, and comfortable in a fast-paced contract manufacturing environment. Able to manage multiple projects simultaneously, ensuring on-time delivery and customer satisfaction.

The Senior Manager, Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for managing clinical and commercial product quality to ensure global supply for Otsuka's patients. **** + Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics manufacturing processes, ensuring GMP compliance for cell culture, bioprocessing, purification, and formulation activities. + Responsible for the day-to-day quality oversight of assigned GMP contract manufacturers. + Responsible for the OPDC GPQ batch record review and release activities of assigned products (API, Drug Product and Final Packaged/Labeled Investigational Medicinal Product) for use in clinical studies and commercial products. + Works collaboratively with GMP Suppliers, OPDC Technical Operations, QC and Clinical Supplies Operations, and other Otsuka Companies, Affiliates and Subsidiaries as applicable in releasing R&D products for use in clinical studies and commercial supply. + Reviews/approves deviations, investigations, CAPA plans and change controls per Otsuka Policies and Procedures. Dispositions quality system records to ensure their timely initiation, execution, and closure. + Provides quality oversight for QC-related activities that support OPDC R&D products; including LIMS data, method development & validation, method transfers and testing (release, stability). + Maintains KPIs/quality metrics to monitor performance and help drive continuous improvement activities. + Negotiates quality agreements for assigned GMP Suppliers and ensures they are established per Otsuka Policies and Procedures. + Participates in audits of GMP Suppliers to ensure compliance with local and global requirements as well as applicable regulatory requirements. + Works collaboratively with local and global Otsuka departments and GMP Suppliers in support of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams supporting research and development projects to assure that the goals set by the team as they relate to potential suppliers are consistent with global and local quality objectives and relevant governmental requirements. **Qualifications** Required + Bachelor's degree in Chemistry, Biology, Engineering or related Science. + Four years of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Products or Commercial Products. + Two to three years of quality experience in managing CMOs/CDMOs (or experience in internal/external auditing). + Proven experience with biologics GMP DS and DP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes.as well small molecule manufacturing. + Ability to handle interactions and resolve issues with internal customers and GMP suppliers in a tactful, professional, and effective manner. + Experience in using MS Office (Word, Excel, PowerPoint). + Experience in using TrackWise. + Excellent interpersonal and communication skills. + Technical Writing Experience: writing Investigations and performing root cause analysis. + Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections for NDAs and BLAs. + Analytical problem solving and decision-making skills. + Ability to identify gaps/risks and propose corrective and preventative actions. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Experience with quality oversight of controlled substances. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $131,153.00 - Maximum $196,075.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.