Product Management Director jobs at Astellas Pharma - 933 jobs

A pioneering biotechnology firm in Boston, MA, is seeking a Director of Vector Engineering to oversee the discovery strategy for novel lentiviral vectors. The ideal candidate will have over 8 years of experience in gene therapy R&D, strong leadership skills, and a proven track record in optimizing viral vectors. This dynamic role involves collaborating across teams and managing projects that have a tangible impact on patient outcomes, all within a supportive and innovative environment. #J-18808-Ljbffr

Mastronardi Produce pioneered the commercial greenhouse industry in North America, and we're now the leading greenhouse vegetable company on the continent. Our award-winning, flavorful produce is packed under the SUNSET brand and is available at leading grocery retailers across North America. Family owned for over 65 years, we pride ourselves on having the most flavorful products and the best people in the industry. We are constantly pushing boundaries to be a leader in fresh produce innovation. We seek individuals that demonstrate our PRIDE values (Passion, Respect, Innovation, Drive, Excellence) to help us fulfill our mission to inspire healthy living through WOW flavor experiences. Our corporate office in Livonia, Michigan is currently seeking a Director, Pricing and Strategy to join our team. In this role you will be collaborating with Procurement & Planning teams on short-term & long-term Sales Pricing Strategy. You will also be responsible for implementation & execution of Pricing Strategy with the Sales Team. Values: To perform the job successfully, the incumbent's behavior must be consistent with the PRIDE values expected of all Mastronardi Produce employees: be Passionate; have Respect; be Innovative; be Driven and strive for Excellence. Primary Responsibilities: Collaborating with Procurement & Planning team on short-term & long-term Sales Pricing Strategy Implementation & execution of Pricing Strategy with the Sales Team Periodic reviews of wins/losses/opportunities with Sales & Executive team Develop promotional strategy tailored to each retailer driven by market intel Implementation & execution of Promotional Strategy with Sales Team Tracking execution & reviewing with Sales Team & Retailers End-to-End Digital Marketing Strategy for retailers Understanding of short-term & long-term market impacts to retail pricing Attend customer meetings as needed Travel to Kingsville 1-2x/week Education, Background/Qualifications Required: Bachelor's degree or College degree in a related field preferred At least 5 years experience in a leadership capacity developing Pricing strategies and execution Digital Marketing and Sales planning experience Specific Knowledge, Skills and Abilities Required: Advanced Data Analytics: Proficiency in interpreting complex datasets using tools like SQL, Tableau, Power BI, and advanced Excel (Pivot Tables, VLOOKUPs, modeling). Familiarity and experience with syndicated data platforms such as Circana or Nielsen Market & Competitive Intelligence: Ability to conduct deep-dive research into competitor pricing, consumer behavior, and industry trends to identify differentiation opportunities. Digital Marketing Integration: Understanding how pricing impacts digital channels, including SEO, PPC, and e-commerce conversion rates. Strong customer, quality and continuous improvement focus Strong attention to detail with ability to respond and act as needed Strong analytical and problem-solving skills Working independently with minimal supervision Knowledge and understanding pricing and sales strategies Comprehensive knowledge of Digital marketing tactics and best practices Willingness to maintain confidentiality and protect proprietary information and company Willingness to work with a high degree of professionalism and personal Strong organizational, analytical and problem-solving need to be creative. Please note: Mastronardi Produce has accommodation processes and policies in place and provides accommodation for employees with disabilities. If you require a specific accommodation because of a disability or documented medical need, please contact the Human Resource office so that arrangements can be made for the appropriate accommodation to be put in place. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

The Biopharmaceutical Business Unit (BBU) bridges science and commercial, integrating corporate, portfolio, therapy areas and product strategies, providing strategic direction from early‑stage research through to commercialization. Cell therapy has the potential to change the treatment paradigm of autoimmune disease, offering a new modality that may provide deep and durable response in difficult to treat, chronic diseases. AstraZeneca is establishing a portfolio of cell therapy options to address multiple autoimmune and neurology diseases, in collaboration with the oncology and rare disease business units. Within the Global Respiratory & Immunology (R&I) Therapeutic Area, reporting to the Head of Cell Therapy, Immunology, you will help craft AZ's future portfolio by driving commercial activities for our launch into the Cell Therapy space across multiple autoimmune diseases. You will be expected to have a high level of collaboration with global functions (e.g. R&D, Business Insight / Analytics, Finance, Medical Affairs, Pricing & Market Access) and our local Marketing Companies, in particular in the US. Close collaboration with our global oncology and rare disease business units will also be key to success. In this role, you will evolve the global commercial strategy for immunology cell therapy, developing critical insights to drive our approach and defining the go‑to‑market model. You will collaborate closely with the US leadership team as well as the Global Immunology Cell Therapy Commercial and R&D colleagues to ensure fit‑for‑purpose solutions are proposed, that serve both the enterprise and the US marketing company. The successful candidate must be a very strong matrix operator, good communicator and well‑rounded commercial thinker, with a specific appetite for cross‑functional collaboration and entering yet‑to‑be established commercial markets. Clear strategic thinking with the ability to lead and demonstrate passion for the brands and future technology is required, given the desire of AZ to be a future leader in cell therapy across multiple diseases and settings. What you'll do: Develop and implement winning commercial strategies for the clinical stage cell therapy asset, working with the Head of Cell Immunology Cell Therapy to ensure robust and compelling positioning and competitive differentiation based on deep market insights Shape pre‑launch and launch plans, building clear, market‑defining programs that position the brand around unmet needs Collaborate with Commercial Leadership and engage with Regional and Country teams to ensure strategic alignment and share best practices, delivering the global ambition Drive understanding of the requirements for a go‑to‑market strategy and customer engagement model for immunology and integration with other business units Continue to drive patient centricity and innovation through all aspects of immunology cell therapy strategy Lead commercial readiness for investment decisions in one or more LCM indication opportunities Contribute to BD assessments of external opportunities in cell therapy and beyond to evolve the cell therapy portfolio Engage with Key External Experts (KEEs) to gather input to inform the respiratory strategy and activities plan including advocacy development Produce future‑ready revenue forecasts and business cases through rigorous customer insight and commercial judgement Oversee budgets and agency workflows, ensuring resources are aligned to maximize campaign impact and efficiency Minimum Qualifications and capabilities: Bachelor's degree is required in Business, Medical or Life sciences 10+ years of experience in pharmaceutical development and commercialization Significant and in‑depth understanding of global commercial strategy, methodologies and tools (product profiling and positioning, forecasting, pricing and reimbursement, market research techniques, competitive intelligence resources) Experience of crafting brand strategy whilst the understanding of product profile was incomplete and evolving Detailed ‘hands‑on' knowledge of building TPPs, generating sales forecasts and business cases Thorough understanding of the drug development process and the need for commercial line of sight throughout Understanding of future healthcare market challenges Strong interpersonal and team leadership skills, demonstrating flexibility and a validated ability to deal with complexity under time pressure Proven strong influencing skills and stakeholder management Experienced and comfortable working in a matrix environment Preferred Qualifications and capabilities: An advanced degree (MBA, MSc or PhD) Experience in immunology Experience in both market and global commercial organisations Launch experience Why AstraZeneca? At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life‑changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio‑pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey. So, what's next! Are you already imagining yourself joining our team? Good, because we can't wait to hear from you. The annual base pay for this position ranges from $229,303 to $343,955. Hourly and salaried non‑exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job‑related knowledge, skills, and experience. In addition, our positions offer a short‑term incentive bonus opportunity; eligibility to participate in our equity‑based long‑term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at‑will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Compensation Pay Range: 229,303.20 - 343,954.80 USD Annual Date Posted 08-Jan-2026 Closing Date 22-Jan-2026 Equal Opportunity Employer Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr

A leading biopharmaceutical company is seeking a strategic marketer to drive brand strategy and execution in the cardiovascular space. This role requires collaboration with internal teams globally and focuses on shaping operational plans. The ideal candidate will bring over 6 years of pharmaceutical marketing experience, proven leadership skills, and the ability to engage with external stakeholders. Competitive compensation and incentives offered, with a strong emphasis on team collaboration. #J-18808-Ljbffr

A global healthcare company seeks a Director of Product Brand Marketing for their Robotics & Digital Solutions organization. The position, based in Santa Clara, CA or Cincinnati, OH, involves leading the development of a brand narrative and multi-channel communication strategy for the Ottava Surgical Robotics Portfolio. The ideal candidate has a Bachelor's degree, extensive experience in brand management, and a proven ability in cross-functional collaboration, along with strong communication and leadership skills. This role may require travel and offers a competitive salary. #J-18808-Ljbffr

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. Job Description Purpose Provide leadership for the capital planning and strategy development aspects of the Global Engineering function. This includes leading the development of ongoing capital investment strategy for the global manufacturing network (IME) and oversight of the capital planning processes for all AbbVie operations. Lead engineering Front End Planning (FEP) activities in support of network strategy development including asset utilization modeling, capital cost estimation, business development deal input, pipeline technology assessment and network scenario development. Provides leadership for and ownership of all capital planning processes within Operations supporting the major financial cycles (Long Range Planning, Annual Plan, Update) to ensure optimal use of Operations capital. Provide recommendations to IME senior leadership on investments to optimize the manufacturing network footprint while maintaining assurance of supply and geographic balance. Remain abreast of emerging technologies and the state of the industry to inform network LRP strategy. Establish and maintain appropriate relationships with external engineering, architectural and peer organizations to facilitate benchmarking and incorporation of best practices into Global Engineering business processes. Provide project management, direction and oversight to the Global Engineering Programs department. Coordinate facility and utility projects to ensure adherence to AbbVie standards and specifications. Develop resource plans for approved projects and make recommendations regarding use of internal or external resources for project/facility planning, design and execution. Manage and leverage common engineering systems. Responsibilities Lead experienced team of project engineers in scenario development and capital cost estimation for projects ranging from $1MM - $200MM. Accountable for all processes, policies and procedures related to capital planning. Responsible for Operations-wide capital planning processes for all financial cycles (LRP, Plan, Update) with an annual investment spend of >$400MM. Responsible for asset utilization modeling and development of multi‑year investment strategies for a global network of 27 manufacturing sites. Conduct and record benchmarking of capital cost estimation best practices within AbbVie and professional associations, A&E firms and other peer companies. Lead and coordinate objective criticality scoring of site‑level projects to deliver network‑wide investment prioritization. Establish and maintain relationships with senior Operations functional leaders (QA, Central Services, S&T, BTS, etc.) to support development of functional capital plans and provide engineering support. Interface with sites (leadership and engineering) to assemble and maintain a library of capability and capacity information to inform investment decisions and strategy. Build partnership with S&T/R&D to ensure network technology preparedness to support the pipeline and influence key decisions early in the product development lifecycle. Qualifications Bachelor's Degree in Engineering. Master's Degree in Management or an MBA preferred. 10‑15 years of experience in Engineering and/or Manufacturing Management. Key Stakeholders SVP, Internal Manufacturing and Engineering; Regional VPs Manufacturing; VP, Global Engineering Additional Information The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short‑term incentive programs. AbbVie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. Equal Employment Opportunity US & Puerto Rico only - to learn more, visit ************************************************************************* Reasonable Accommodation US & Puerto Rico applicants seeking a reasonable accommodation can learn more at ************************************************************* #J-18808-Ljbffr

A leading pharmaceutical company in Boston is hiring a Senior Director in Statistics to enhance their R&D capabilities. The role emphasizes strategic leadership, cross-functional collaboration, and improving therapeutic outcomes through data-driven methodologies. Candidates should possess advanced knowledge of drug development processes and strong statistical programming skills. An equitable compensation package includes a base salary range of $208,200 - $327,140 and comprehensive benefits for full-time employees. #J-18808-Ljbffr

Objective / Purpose: The Head of Design & Delivery, PharmSci will lead the global digital product strategy across Takeda's Pharmaceutical Sciences Digital Data & Technology (DDT) portfolio, driving innovation and operational excellence across the CMC lifecycle. This leadership role is accountable for shaping and delivering innovative, compliant, and business‑aligned digital solutions. You will manage a global team of product managers and work cross‑functionally to ensure that Takeda's technology platforms are innovative, modern, scalable, and enable faster delivery of medicines to patients. Responsibilities Drive the delivery strategy for multi‑year enterprise impacting programs and products including critical digital transformation initiatives such as Aedificus Fortis (AF), In Silico First and digitization of internal clinical manufacturing projects. Elevate the product management teams to be seen as strategic partners ensuring delivery of fit for purpose digital solutions that meet the evolving needs of PharmSci and beyond. Define and execute the strategic product roadmap across PharmSci products including but not limited to Scientific Data products (Tetrascience, ECM, SDMS), GMP Clinical Manufacturing products (MES, ERP, MODA, LIMS), Knowledge management product (PLM, R&D Search), and Drug and Device Management Lab Validation. Structure and resource product teams based on demand planning to support strategic roadmaps. Ensure platforms are integrated, compliant, and user‑centric across all business areas. Build, upskill, and lead a high‑performing global product management team. Foster a product‑driven agile culture to support delivery excellence. Collaborate with senior leaders across PharmSci, Research and RDDT including Business Partners, Tech Services, Data and AI delivery to align technology strategies with evolving business needs. Identify and integrate emerging technologies (e.g., automation, AI/ML, NLP) into the product portfolio to drive operational excellence and innovation in CMC and device design. Ensure all products are developed and maintained in compliance with global regulations (e.g., GxP, 21 CFR Part 11, FDA) and Takeda's quality and risk management standards. Work closely with architecture, engineering, quality, and data teams to ensure scalable and interoperable solutions across R&D. Represent PharmSci product leadership in strategic governance forums, investment planning committees, and external regulatory or industry working groups as needed. Ensure alignment of product solutions to Takeda's short and long‑term goals, both tactical and strategic. Lead and mentor Product Oriented Delivery (POD) Leads, Technical Leads, Business Analysts, and Quality Engineers, fostering a collaborative and high‑performing environment. Provide guidance and coaching to team members and teams, reviewing and assessing team performance and identifying areas for improvement. Drive alignment between POD capacity and evolving business needs ensuring agility in responding to high‑impact initiatives. Responsible for stakeholder management, driving cross‑functional collaboration, cross‑enterprise influence and communication to ensure smooth product delivery and alignment with stakeholder expectations. Handle risk management, identifying potential project/product risks and implementing mitigation strategies. Oversee project budgets, resource allocation, and timelines to ensure timely delivery of projects within budget and in adherence to quality standards. Education & Competencies (Technical and Behavioral) Required Bachelor's degree in Life Sciences, Information Technology, Engineering, or a related field; advanced degree (e.g., MBA, MS) strongly preferred. 12+ years of experience in pharmaceutical R&D technology or digital product leadership roles, with deep expertise across Pharmaceutical Sciences. Strong understanding of CMC processes, GxP, regulatory compliance and global quality standards. Demonstrated ability to lead product teams through complex, regulated environments using modern product management and agile delivery frameworks. Strategic thinker with outstanding leadership, communication, and stakeholder engagement skills. Proven success managing global teams, product portfolios, and vendor ecosystems. Minimum 8 years of people leadership experience within a technology or product development environment and influencing senior‑level management and key stakeholders. Preferred Master's degree in Information Technology, Life Sciences or a related field. Technical Competencies Experience with technology platforms such as Tetrascience, PLM, OpenLabs, MES, SAP ERP, and/or both regulated and non‑regulated lab informatics and automation tools. Knowledge of current industry trends and emerging technologies in the R&D and Pharmaceutical Sciences. Ability to propose and prioritize future technical investments, assessing trade‑offs between technical risks and potential benefits/rewards. Knowledge of product management and key trends associated with them. Knowledge of project management principles and methodologies with a proven track record in delivering complex technology projects. Behavioral Competencies Ability to thrive in a dynamic environment. Experience with prototyping tools and techniques. Demonstrated verbal and written communication, presentation, and negotiation skills. Ability to manage and influence a variety of stakeholders at all levels. Ability to make highly complex decisions that impact the enterprise. Demonstrated problem‑solving skills, with the ability to work effectively under pressure and adapt to changing priorities. Ability to manage financial and people resources across multiple business functions, portfolios, and projects. Ability to understand and collaborate with customer and/or business partner needs through dialogue to resolve conflict in a constructive manner, before recommending solutions. Demonstrated ability to work across functions, regions and cultures. Enterprise level leadership with the ability to inspire, motivate and drive results. Ability to present complex information clearly and with confidence. Proven skills as an effective team player who can engender credibility and confidence within and outside the company. Foster solutions‑oriented thinking by fostering a culture of performance, accountability, simplicity, empowerment, external orientation and curiosity. Effectively navigate the changing external and internal environment and lead others through change by creating and inspiring and engaging workplace. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. Location Boston, MA U.S. Base Salary Range $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short‑term and/or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Worker Type Employee Worker Sub‑Type Regular Time Type Full time Job Exempt Yes. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr

A leading pharmaceutical company is seeking a Brand Team Leader to oversee strategic development and execution of marketing efforts for the Eye Care portfolio. The role requires expertise in sales management, strong leadership capabilities, and the ability to integrate local insights into brand strategy. The ideal candidate will have a proven track record in marketing within the pharmaceutical industry, effective communication skills, and a Bachelor's degree. This position will be located in New York, and offers a dynamic work environment focused on innovation. #J-18808-Ljbffr

Regional Ecosystem Lead (US Westcoast) page is loaded## Regional Ecosystem Lead (US Westcoast)locations: SQ\_San Francisco\_Remote: USA - CA - San Diego - Remotetime type: 正社員posted on: 募集開始 - 今日time left to apply: 終了日: 2026年2月4日 (応募可能な残り時間: 13 日)job requisition id: R-269764責任:• 関連するR&D拠点において,研究に従事する社員の指導と能力開発に責任を負う。• 新製品の創見,開発,製造,および既存製品の改善を目的とした,関連ファンクション／研究分野に適した戦略の設計および実施に貢献する。• 新製品の創見,開発,製造,および既存製品の改善に関連する活動の実施を指揮する責任を負う。• 経営幹部に技術的な報告と助言を提供する。望ましい応募資格:• 関連分野の博士号• 業界の業務経験またはそれに相当する経験で,関連する学術的環境における科学管理職としての最低10年の経験• ファンクションの全般的な多文化の国際研究開発チームを主導した実績• 優れたコミュニケーション能力（英語 )## **About CSL Behring**CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .**Our Benefits**For more information on CSL benefits visit .**You Belong at CSL**At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************************************************** Opportunity Employer**CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit . #J-18808-Ljbffr

Director, REMS Global Safety Scientist, Medical Safety and Risk Management Who we are:At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion - because our differences shape how we hire, collaborate, and innovate. Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific - it's deeply personal, grounded in the meaningful connections we have built. To learn more, visit www. agios. com and follow Agios on LinkedIn and X. The impact you will make:Agios Pharmaceuticals is searching for a dynamic Director, REMS (Risk Evaluation and Mitigation Strategy) Global Safety Scientist, to join our growing Medical Safety and Risk Management team. We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities. The Director, REMS Global Safety Scientist will be responsible for monitoring, evaluating, and managing the safety profile of assigned products, with a specialized focus on risk minimization activities required by global regulatory agencies such as the FDA and EMA. The ideal candidate will leverage strong scientific writing, analytical skills, and regulatory expertise to ensure product benefits continue to outweigh their risks in both clinical trial and post-marketing environments. What you will do:Lead the authoring, development, and ongoing maintenance of REMS materials Lead the scientific review and authoring for REMS assessment reports Provide vendor oversight as needed Collaborate cross-functionally for internal review of the full REMS assessment reports Author, contribute to, and strategically review aggregate safety reports overall and with a specific focus to REMS requirements and risks that require REMSSupport readiness for internal audits and external regulatory inspections related to REMS activities Organize, direct and manage technical and human resources to efficiently support the management of REMS safety data in accordance with FDA safety regulations Liaise with safety systems for required outputs Collaborate with medical risk management function Drive timely decisions and appropriately shift functional timelines, resources and priorities Other Safety Scientist Responsibilities:Conduct signal detection and management activities Develop and maintain risk management plans Manage direct report performance against goals; supporting and consulting as necessary Serve as functional owner of SOPs and Work Instructions related to functional area Serve as a point of escalation for issue resolution What you bring:Health care professional (e. g. RN, pharmacist, or other life sciences experience) with a minimum of 6 years of relevant drug safety/pharmacovigilance experience; training in pharmacology, epidemiology or regulatory science is a plus Able to oversee and manage direct reports and vendors Excellent written/verbal communication and interpersonal skills Strong planning and organization skills Strong analytical skills and the ability to interpret complex clinical and safety data Excellent scientific writing and communication skills, with attention to detail Ability to work independently, manage multiple projects simultaneously, and collaborate effectively in a team environment. Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you're excited about this role but your previous experience doesn't align perfectly with the , we still encourage you to apply. You may be just the right candidate for this role or another opening! Work Location:Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description. What we will give you:Deliberate Development. Your professional growth as one of our top priorities. Flexibility. We're all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you're at your best, we're at our best. Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website. Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance. The current base salary range for this position is expected to be between $183,549 - $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries. Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We're continuously looking to improve the inclusivity of our workforce. Commitment to community. We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked. Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.

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. Position Summary We are seeking a Group Product Manager to identify customer-centric, high-value marketing programs that drive accelerated product adoption and growth. They will work closely with regional partners to achieve success. This role will focus on solutions within the Advanced Patient Monitoring portfolio which provide advanced hemodynamic monitoring. The ideal candidate brings both strategic vision and executional excellence-able to translate insights into impactful programs, lead agencies with confidence, and clearly demonstrate results. Key Responsibilities: Develop and lead in the execution of comprehensive marketing plans including strategies and tactics for multiple major product launches or programs and initiatives Build relationships with key opinion leaders (KOL) to help inform customer engagement plans and understand current market environment and competition Develop marketing messages based on regional strategies, knowledge of current literature, current competitive environment, and regulatory/legal requirements for multiple major product launches or programs and initiatives Develop programs that support the field and commercialization strategies for multiple major initiatives Lead major projects for the Congress Management process Drive marketing collateral/labeling through all relevant legal and regulatory approval processes through collaboration with relevant cross-functional stakeholders for multiple major product launches or programs and initiatives Lead the execution of multiple major programs and initiatives in collaboration with regional partners as appropriate including Salesforce readiness (e.g., training on product, messaging, and competition) Define and build a body of clinical and economic evidence that supports the regional value proposition Manage budgets related to product line, campaigns and projects Analyze clinical and market data to assess regional impact of potential product launches Lead significant process or corporate initiatives that impact and bring value to the marketing organization Education requirements: Bachelor's degree with 10 years of marketing experience, including downstream marketing required, or Master's degree with 8 years of experience, including downstream marketing, required Healthcare industry experience strongly preferred Required Skills: Proven successful project management skills Proven expertise in Microsoft Office Suite Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives required Expert understanding of related aspects of marketing concepts and principles required including understanding of broad market research designs, develops market research programs coordinating with the global VOC manager and demonstrates an in-depth understanding of commercial goals behind research required Ability to forecast product lines for short-term and long-term accuracy based on market development, sales trends, competition and changing market dynamics required Ability to assess and understand market share, pricing, ASPs, competitive dynamics required Strong clinical knowledge, experience and knowledge of the clinical areas where our products are used or intended to be used, understand the purchasing process and challenges for product adoption in complex healthcare networks preferred Strict attention to detail required Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization required Ability to manage competing priorities in a fast-paced environment required Experience leading projects working closely with cross-functional teams, marketing peers and leaders and managing needs and messaging to upper management required 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. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. 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 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 - Irvine Laguna CanyonAdditional 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

Vertex is seeking a strategic Senior Director to lead AI Product Management within our Commercial Technology organization. This role will be responsible for building and managing a portfolio of high-value commercial AI products that automate operations, accelerate patient access, and enhance customer experience. The Senior Director will define and drive the AI strategy, lead the development and adoption of agentic AI-powered solutions, and collaborate closely with business engagement and platform teams to deliver measurable value. A key focus will be on defining and tracking the impact of AI investments, fostering upskilling and capability building across the functional teams to ensure successful adoption of AI and GenAI capabilities. Key Duties and Responsibilities Define and lead the AI product vision, roadmap, and lifecycle for commercial technology initiatives. Translate complex business needs into scalable AI solutions that drive measurable value across marketing, market access, and field operations. Partner with Commercial, Data Science, IT, and external stakeholders to identify high-impact AI opportunities aligned with business goals. Lead cross-functional teams through the full product lifecycle-from ideation and design to development, deployment, and optimization. Horizon scan and identify emerging AI technologies, build and manage AI product roadmap, and drive adoption of cutting-edge autonomous commercial solutions. Ensure AI products meet compliance, legal, and ethical standards, including data privacy and regulatory requirements. Champion a culture of innovation, experimentation, and continuous improvement in AI product development. Serve as a trusted advisor to senior leadership, providing insights and recommendations grounded in data and commercial strategy. Knowledge and Skills Proven expertise in AI/ML product management within a commercial or healthcare technology context. Deep understanding of commercial strategy, market access, and the pharmaceutical value chain. Strong leadership in cross-functional environments, with the ability to influence and align diverse stakeholders. Demonstrated ability to translate business challenges into AI-driven solutions with measurable outcomes. Advanced proficiency in commercial competencies including: Insight Generation: Forecasting, data synthesis, and customer experience insights. Commercial Strategy: Portfolio planning, lifecycle management, and brand value creation. Commercial Execution: Market access planning, vendor management, and performance accountability. Business-Minded Leadership: Risk management, resource allocation, and innovation strategy. Influential Communication: Executive-level storytelling, negotiation, and stakeholder engagement. Trusted Partnership: Cross-functional collaboration and inclusive leadership. Education and Experience Bachelor's degree in a relevant field (e.g., Business, Computer Science, Engineering); advanced degree (MBA, MS, PhD) preferred. Experience in the biotech, pharmaceutical, or healthcare technology industry strongly preferred. 12+ years' experience with 3+ years pharmaceutical commercial domain experience Strong experience setting agentic AI vision and governance framework development Prior experience building and embedding A.I. into an organization Understanding of multi-agent, hierarchal structures and orchestration e.g. integrating agents and AI solutions with other agents/ platforms across an end-to-end process Hands-on experience with LLM APIs (OpenAI, Anthropic, Azure OpenAI) Fine-tuning and context engineering for domain-specific applications Knowledge of model evaluation and performance optimization techniques Emerging technology evaluation, horizon scanning and partnership management experience Hands-on experience building and deploying agentic AI in Pharma/Life Sciences Change management and technology adoption expertise Executive communication and influence skills Pay Range: $236,000 - $354,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

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.

Director, REMS Global Safety Scientist, Medical Safety and Risk Management Who we are: At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture - one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion - because our differences shape how we hire, collaborate, and innovate. Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific - it's deeply personal, grounded in the meaningful connections we have built. To learn more, visit www. agios. com and follow Agios on LinkedIn and X . The impact you will make: Agios Pharmaceuticals is searching for a dynamic Director, REMS (Risk Evaluation and Mitigation Strategy) Global Safety Scientist , to join our growing Medical Safety and Risk Management team. We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities. The Director, REMS Global Safety Scientist will be responsible for monitoring, evaluating, and managing the safety profile of assigned products, with a specialized focus on risk minimization activities required by global regulatory agencies such as the FDA and EMA. The ideal candidate will leverage strong scientific writing, analytical skills, and regulatory expertise to ensure product benefits continue to outweigh their risks in both clinical trial and post-marketing environments. What you will do: Lead the authoring, development, and ongoing maintenance of REMS materials Lead the scientific review and authoring for REMS assessment reports Provide vendor oversight as needed Collaborate cross-functionally for internal review of the full REMS assessment reports Author, contribute to, and strategically review aggregate safety reports overall and with a specific focus to REMS requirements and risks that require REMS Support readiness for internal audits and external regulatory inspections related to REMS activities Organize, direct and manage technical and human resources to efficiently support the management of REMS safety data in accordance with FDA safety regulations Liaise with safety systems for required outputs Collaborate with medical risk management function Drive timely decisions and appropriately shift functional timelines, resources and priorities Other Safety Scientist Responsibilities: Conduct signal detection and management activities Develop and maintain risk management plans Manage direct report performance against goals; supporting and consulting as necessary Serve as functional owner of SOPs and Work Instructions related to functional area Serve as a point of escalation for issue resolution What you bring: Health care professional (e. g. RN, pharmacist, or other life sciences experience) with a minimum of 6 years of relevant drug safety/pharmacovigilance experience; training in pharmacology, epidemiology or regulatory science is a plus Able to oversee and manage direct reports and vendors Excellent written/verbal communication and interpersonal skills Strong planning and organization skills Strong analytical skills and the ability to interpret complex clinical and safety data Excellent scientific writing and communication skills, with attention to detail Ability to work independently, manage multiple projects simultaneously, and collaborate effectively in a team environment. Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you're excited about this role but your previous experience doesn't align perfectly with the , we still encourage you to apply. You may be just the right candidate for this role or another opening! Work Location: Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description. What we will give you: Deliberate Development. Your professional growth as one of our top priorities. Flexibility. We're all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you're at your best, we're at our best. Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website. Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance. The current base salary range for this position is expected to be between $183,549 - $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries. Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We're continuously looking to improve the inclusivity of our workforce. Commitment to community. We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked. Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.

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.

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.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose & Scope: We are seeking an experienced leader to serve as the Identity & Security Engineering Lead. This role will be responsible for defining strategy, leading teams, and ensuring operational excellence across our Microsoft identity management platforms while also overseeing broader security engineering domains including cloud security, OT security, application security, and infrastructure security. A critical focus area will be advancing our Multi-Factor Authentication (MFA), Conditional Access, and Privileged Access Management (PAM) capabilities to enable secure, seamless user experiences. Beyond identity, this leader will drive security engineering excellence across cloud, OT, and enterprise platforms. This role will be accountable for global delivery through a hybrid workforce model, managing both internal engineering teams and external service providers/partners across multiple regions and time zones. Operating within an agile delivery model, the Identity & Security Engineering Lead will ensure identity and security engineering capabilities are delivered with speed, adaptability, and business alignment. The role may be based in the United States, Canada, United Kingdom, Poland, Mexico, India, or Japan, with global responsibilities across all regions. Responsibilities and Accountabilities: Strategic Leadership · Define and execute the enterprise vision for Microsoft Identity platforms (Active Directory, Azure AD / Entra ID, M365 Identity Services, MFA, Conditional Access, PAM). · Lead strategy and delivery across broader security engineering domains including cloud security, OT security, and infrastructure/application security. · Drive a global MFA-first strategy, embedding Zero Trust principles across the enterprise. · Ensure identity and security engineering programs support digital transformation, cloud adoption, and regulatory compliance. Operational Excellence · Ensure global reliability and performance of MFA and Conditional Access policies. · Automate identity lifecycle management (provisioning, de-provisioning, access reviews, PAM). · Deliver security engineering solutions for cloud platforms (Azure, AWS, GCP) and OT/critical infrastructure environments. · Apply agile delivery methodologies to accelerate delivery, manage backlogs, and adapt quickly to evolving requirements. · Manage service delivery performance across both internal teams and external vendor partners. · Risk, Compliance & Governance · Partner with GRC to ensure identity and security engineering controls meet NIST CSF, ISO 27001, SOX, HIPAA, EU AI Act, and other regulatory frameworks. · Lead audit and compliance programs across identity, cloud, and OT security domains. · Anticipate and mitigate emerging risks by adapting MFA and security engineering strategies. Collaboration & Influence · Serve as a trusted partner across infrastructure, applications, OT, business stakeholders, and senior executives. · Position MFA, identity, and security engineering as key enablers of business productivity and compliance. · Represent the function in enterprise-wide programs including global network refresh, cloud adoption, OT modernization, and M&A integrations. · People & Talent Leadership · Lead and mentor a global team of internal and external resources, ensuring alignment and accountability across multiple regions and time zones. · Foster agile, cross-functional teams that collaborate across infrastructure, applications, and business domains. · Manage vendor partnerships and enforce accountability for quality, SLAs, and innovation. · Develop succession plans, training paths, and career opportunities in Microsoft identity, MFA, and advanced security engineering. · Promote a culture of inclusion, agility, innovation, and continuous improvement.