10 quality control jobs found in Indianapolis

The Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances. Key Responsibilities Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers. Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters. Quality & Compliance:Serve as the quality and compliance lead for controlled...

Job Description Team Overview The Data Center Infrastructure Delivery team at Oracle Cloud Infrastructure is a dynamic group of professionals dedicated to delivering state-of-the-art data center facilities at scale and at pace. This team comprises experienced project managers who work collaboratively with vendors and internal teams to ensure the successful execution of complex data center construction and network projects. They bring a wealth of expertise in project management, technical design, and on-site construction, ensuring that our data centers meet the highest standards of quality, efficiency, and sustainability. This team plays a crucial role in supporting Oracle Cloud Infrastructure's data needs and driving our growth and success. Job Summary Strategically, you will be responsible for developing and implementing comprehensive plans that optimize efficiency, cost-effectiveness, and operational excellence in delivery. You will engage with key stakeholders,...

About Ossium Ossium's mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good. Ossium's mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good. About the Job We're hiring a Quality Assurance Specialist to focus on Product Quality and uphold compliance with internal/external standards,...

The Manager, Manufacturing Product Quality (Small molecule) is responsible for ensuring GMP compliance in the manufacturing packaging, labeling, and distribution of commercial and clinical trial materials across global operations. This role supports the oversight of manufacturing and packaging activities performed internally and at external vendors, ensuring that quality standards are met and regulatory requirements are maintained throughout the commercial and clinical supply chains. The manager will collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, and Supply Chain to ensure the integrity and traceability of investigational products from manufacturing and packaging through delivery. Key Responsibilities Oversee manufacturing of commercial and clinical products at contract manufacturers to ensure compliance with GMP, and applicable global regulatory requirements. Performs batch record review and quality release...

Company : Highmark Health Job Description : JOB SUMMARY The Director of Data Product Management is a leadership role responsible for developing, implementing, and continually refining our customer data product strategy from its foundational stages. This individual will define, develop, and execute the strategy for our core customer data products, ensuring they meet the evolving needs of Highmark and our customers. This individual will lead a team of product managers and analysts focused on specific areas of customer data, driving the realization of our Customer Data Product Strategy vision to empower downstream teams with personalized, high-quality, and timely interactions. This role requires a strong leader who can translate strategic opportunities into actionable product roadmaps, champion data quality and governance, and foster a data-driven culture. A robust technical background and the ability to effectively collaborate with engineering teams are paramount to...

Company : Highmark Health Job Description : JOB SUMMARY This is a hybrid role if you live within a 50 mile radius of one of our office locations in PA, NY or DE This role is responsible for contributing to the product strategy and roadmap for a defined product area, by managing a team while working under the direction of leadership. This role focuses on deeply understanding customer needs, market trends, and competitive landscape to inform product development decisions. The incumbent works cross-functionally to manage a team that is executing a portfolio roadmap or portfolio of product roadmaps and delivering high-quality products that meet business objectives. They will manage the product backlog for a specific product or feature set. ESSENTIAL RESPONSIBILITIES Perform management responsibilities to include, but are not limited to: involved in hiring and termination decisions, coaching and development, rewards and recognition, performance...

The Manager, Global Product Quality - Clinical Packaging is responsible for ensuring GMP and GCP compliance in the packaging, labeling, and distribution of clinical trial materials across global operations. This role supports the oversight of clinical packaging activities performed internally and at external vendors, ensuring that quality standards are met and regulatory requirements are maintained throughout the clinical supply chain. The manager will collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, and Supply Chain to ensure the integrity and traceability of investigational products from packaging through delivery. Key Responsibilities Oversee clinical packaging operations to ensure compliance with GMP, GCP, and applicable global regulatory requirements. In collaboration with the supplier quality team, support qualification and monitoring of external clinical packaging vendors, including audits and performance...

At Prime Therapeutics (Prime), we are a different kind of PBM, with a purpose beyond profits and a unique ability to connect care for those we serve. Looking for a purpose-driven career? Come build the future of pharmacy with us. Job Posting Title Director, Product Marketing - Remote Job Description The Director of Product Marketing is responsible for leading a team that develops, plans, implements and evaluates product and solution marketing strategies, as well as defines audience-appropriate tactics and distribution channels for Prime's clients and/or prospects. This role provides an integrated and strategic approach to marketing and communications planning, understanding the company's business objectives and translating them into effective and compelling communications. Responsibilities Utilize storytelling techniques to communicate product value by crafting compelling narratives that translate complex features into clear, customer-focused benefits and...

Job Description Lead a team that acts as the central resource and driving force for the design, process, manufacturing, test, quality and marketing of product(s) as they move from conception to distribution. Organize interdepartmental activities ensuring completion of the project/product on schedule and within budget. Responsibilities As a member of the product development division, you will analyze and integrate external customer specifications. Suggest and justify product directions and specifications. Specify, design and implement moderate changes to existing software architecture. Build new products and development tools. Build and execute unit tests and unit test plans. Review integration and regression test plans created by QA. Communicate with QA and porting engineering to discuss major changes to functionality. Disclaimer: Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational...

Job Description As a Product Manager in OCI O&M, you will: Use your expertise in full stack observability and IT operations (e.g., log analytics, systems, database, and application management) to collaborate across engineering, marketing, and customers, delivering innovative cloud offerings for Oracle clients. Lead development and define product specifications and strategy for next-generation observability and management cloud services. Act as the central resource and driving force for product design, process, manufacturing, testing, quality, and marketing initiatives-from concept through launch. Coordinate interdepartmental efforts to ensure project/product delivery on schedule and within budget. Specify, design, and implement major software architecture enhancements. Define project requirements and manage execution of unit test plans; review QA integration and regression test strategies; ensure consistency, testability, and...