• Contributes to the development of clinical strategies aligned with regulatory and commercial goals. • Collaborates with R&D, Regulatory, and Marketing on clinical trial designs and endpoints. • Prepares and presents findings of assigned studies to internal and external stakeholders. • Leads and manages the execution of assigned clinical studies. • Oversees protocol development, site selection, budgeting, contracting, and CRO/vendor management for assigned studies. • Ensures adherence to timelines, budgets, and enrollment targets. • Manages resources and quality of clinical projects. • Ensures all clinical activities for assigned studies are compliant with FDA, ISO, and ICH-GCP regulations. • Prepares and reviews study documents including protocols, informed consent forms, monitoring plans, and clinical study reports. • Acts as a liaison with Director, Clinical Research to manage the Clinical Research Associates’ monitoring activities, reports and timelines. • Identifies study risks and proactively implements mitigation strategies. • Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.

• Accountable for the planning, coordination, and conduct of trial activities according to ICH-GCP • Assures the seamless conduct of trials within defined timelines in close coordination and communication with the Clinical Trial Leader (CTL) • Collaborate and interact with other core and extended trial team members • Ensure cooperation with external functions (i.e. Clinical Research Organizations, advisors, investigators) • Independently manage correspondence, complex reports, tracking tools and budget overviews • Oversight of all trial related wrap-up activities (i.e. data cleaning)

Title: Sr Director, Global Quality Operations Location: Greater Cleveland, OH or Deer Park, TX Department: Executive/Director/VP/Global Mgmt Job Description: Job Type: Full-Time, Hybrid (4 days on site, 1 day remote) Travel Requirments: ~50% Shape the Future with Us. At Lubrizol, we’re bringing to life the chemistry behind clean water, efficient transportation, reliable infrastructure, critical medicines, and the products people rely on every day through science, sustainability, and a culture of inclusion. As part of our global team, you’ll be empowered to make a real impact - on your career, your community, and the world around you. How You’ll Make an Impact The Sr Director, Global Quality Operations is an enterprise leader accountable for global quality strategy, governance, and execution across Lubrizol’s worldwide manufacturing and supply network, with direct influence over quality management systems, quality assurance, manufacturing quality control, and commercial risk. The incumbet will strengthen employee engagement, safety, and inclusion by establishing clear expectations, standardized work, and consistent leadership practices. Drive continual improvement of quality management effectiveness, efficiency, and governance to protect customer and company reputation. Additionally, they will standardize and govern customer quality management and technical assistance processes to enhance customer experience and trust. In this role, you will be responsible for - Lead global quality strategy development and execution, aligning enterprise quality objectives with corporate strategy, risk management, and customer requirements. - Drive modernization and simplification of quality management systems, quality assurance, and quality control across Lubrizol’s global footprint. - Govern global quality budgets, and organization, improving productivity while managing compliance, operational risk, and cost control. - Drive quality initiatives and specification management to support product scaling and commercialization by collaborating with R&D, manufacturing, procurement and supply chain teams to consistently translate design intent and performance into reliable commercial production. - Champion data‑driven decision making in quality control, including inspection standardization, paperless laboratory initiatives, and decision science tools. - Develop global quality leadership talent while embedding a quality‑first culture across regions and functions. Required Qualifications that Enables Your Success - Bachelor of Science required; MS preferred in Quality, Regulatory Affairs, Pharmacy, Chemistry or Biology and experience leading Quality Operations at a manufacturing site operation for 5+ years (e.g. Quality Operations, QC Operations, Manufacturing) is required. - 15+ years’ experience in chemical, pharmaceutical or medical device industry with increasing levels of responsibility and leadership in quality assurance, compliance and quality control. Experience with Chemical/Regulated industries a must. - Experience in the development of innovative and action-oriented quality programs are critical. - Strong understanding of the functional areas of manufacturing, sourcing, materials management, quality assurance and control, and laboratory across manufacturing disciplines and segments. - Must have a demonstrable record of implementing and maintaining a total quality system; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics. - Ability to organize time for multiple tasks (major projects and daily functions) and deliver tasks on time. - Effective written/verbal communication skills, organizational skill and ability to deliver formal presentations to leadership/peers or customers. Benefits that Empower You - Competitive salary with performance-based bonus plans - 401(k) match + Age-Weighted Defined Contribution - Comprehensive medical, dental & vision coverage - Health Savings Account (HSA) - Paid holidays, vacation, and parental leave - Flexible work environment - Learning and development opportunities - Career and professional growth - Inclusive culture and vibrant community engagement Learn more at benefits.lubrizol.com! Lubrizol: Imagined for Life. Enabled by Science. ™ Delivered by You. For nearly 100 years, The Lubrizol Corporation, a Berkshire Hathaway company, has been at the forefront of innovation to enhance everyday life, advance mobility, and make the modern world work better. Our specialty chemistry solutions—from engine oils, performance coatings, and skincare to medical devices and plumbing systems —are powered by the expertise, passion, and commitment of people like you. We tackle the world’s toughest challenges with science-based solutions, deeply understanding our customers to deliver innovative chemistry and differentiated value. Our inclusive culture, dedication to safety, and incredible global talent drive our success. Our solutions meet the evolving needs of the modern world—brought to life by science and, most importantly, delivered by you. Whether you're in the lab, on the production floor, or in the office, you'll be part of a team around the world that empowers you to think boldly, drive results, and contribute to solutions that shape a better, more sustainable future. We win because of you. Let’s build the future together.

Role Description Clario, a part of Thermo Fisher Scientific, is expanding its Clinical Adjudication team and is looking for a Clinical Project Manager to support high-impact clinical studies. In this role, you will contribute to ensuring unbiased and standardized evaluation of clinical trial events, supporting the integrity and success of our research. You will collaborate with global stakeholders, lead cross-functional teams, and play a key role in delivering high-quality adjudication services. - Define and execute project plans, including timelines, milestones, and resource requirements aligned with study objectives - Review study protocols and response assessment criteria; partner with stakeholders to develop study start-up documentation and activities - Establish project reporting schedules and provide timely updates to leadership, sponsors, and internal teams - Communicate clearly with project teams, study sites, and sponsor representatives to ensure alignment and transparency - Identify critical success factors and manage project tracking, analysis, and reporting - Coordinate cross-functional resources and partner with departmental leaders to ensure appropriate training and delivery excellence - Manage financial aspects of projects, including forecasting, billing, scope changes, and pass-through costs - Maintain a thorough understanding of project contracts and support revenue reporting requirements - Ensure adherence to SOPs; collaborate with Quality Assurance on clarifications, deviations, and documentation - Lead and develop project teams, setting clear expectations and supporting performance consistency and quality outcomes - Provide coaching and input on team member performance in partnership with functional managers - Support Business Development activities, including capability presentations and participation in client and investigator meetings - Oversee project closeout activities, including submission coordination and final deliverables - Perform supervisory responsibilities where applicable, including hiring support, performance management, and team development - Drive continuous improvement by reviewing and contributing to SOP updates and departmental standards Qualifications - Bachelor’s degree or equivalent experience in life sciences, pharmacy, nursing, or a related healthcare field - Proven project management experience within clinical development or investigational medications - 1–3 years of experience in clinical trials within a CRO or pharmaceutical research organization, ideally in a project management capacity - Working knowledge of GCP/ICH guidelines and FDA regulations - Experience in clinical adjudication strongly preferred - Proficiency with tools such as Microsoft Word, Excel, Access, and Project - Strong interpersonal, communication, and stakeholder management skills - Demonstrated organizational, leadership, and problem-solving abilities - Ability to manage multiple priorities and maintain a high level of professionalism in a fast-paced environment - Commitment to quality, accuracy, and continuous improvement Benefits - Competitive compensation - Private health insurance - Engaging employee programs - Flexible work schedules - Attractive PTO plan - Flex workspace Company Description At Clario, a part of Thermo Fisher Scientific, we put people first, always. We are united and driven by patients, committed to making a difference, and continuously innovating to shape the future of clinical trials. Join us and be part of a team that transforms lives through science and technology.