QA Manager Pharma Product Development

41037 Mirandola, Province of Modena, Italy Req 171 Thursday, September 21, 2023 About Mozarc Medical At Mozarc Medical, our vision is to reimagine the future of holistic kidney health technology. Established in 2023 out of equal investments from DaVita, a leading provider of kidney care services, and Medtronic, one of the world’s largest medical device companies, Mozarc Medical offers an exciting and unique start-up experience backed by the support of two long-time industry and market leaders. Driven by our mission and values, we put our patients at the center of all we do. Our employees play a key role in developing technology solutions that enrich patients’ lives and create meaningful progress in the treatment of kidney disease. Find your purpose and passion at Mozarc Medical. A Day in the Life This Quality Engineering Management position is primarily responsible for overseeing product development activities for Mozarc pharmaceutical products in a global marketplace. This position may also lead and support Quality functional initiatives as well as Quality System improvement activities and establish Mozarc Pharma QMS. This position is accountable for partnering with Research and Development and other functions to deliver high reliability and quality pharmaceutical products through efficient execution of product development activities, change management and meeting quality objectives/metrics for the business. This position is also responsible for ensuring that the product development activities follow all applicable internal, corporate, and regulatory standards or requirements. This position will involve staffing, developing, and resource planning for pharmaceutical design quality assurance. Additionally, this role may serve as a Quality Core Team member on new product development efforts. Mozarc Medical is committed to advancing and delivering optimal kidney care. A Day in the Life: Provide pharmaceutical design quality leadership as the company subject matter expert for sterile pharmaceutical product development and design changes. Ability to look at the larger picture of the development project and influence the Core Team to assure quality objectives are met. Provide direction for quality staff to define adequate process to new pharmaceutical product development. Support R&D and Operations in preparing materials and processes in response to regulatory requests and/or submissions. Build a strong quality engineering team by hiring qualified candidates, establishing performance expectations, and providing training opportunities to direct staff. Responsible for forecasting department headcount and justification/rational of headcount allocation. Serve as a coach/mentor for cross-site Design/Quality Assurance Engineers Supports quality assurance and quality improvement initiatives including supplier qualification, design assurance programs and technology transfers. Demonstrate high technical skills; apply sound engineering judgment, technical, statistical skills, and critical thinking in product development activities and resolution of quality issues. Creatively and effectively challenges status quo when developing and recommending solutions. Lead risk analysis, identifying critical control points and preventive measures, establishing critical limits, monitoring procedures, corrective actions, and verification procedures. Responsibilities may also include the following and other duties may be assigned: Plans, directs and implements all aspects of Mozarc’s design and development of new and existing pharmaceutical products. May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products. Collect and monitor changes in regulations, standards, and guidelines for pharmaceutical product. Implement said changes in the organization. Oversees the investigation and evaluation of existing technologies. Guides the conceptualization of new methodologies, materials, processes or products. Directs the development of new concepts from initial design to market release. Manages feasibility studies of the design to determine if capable of functioning as intended. Monitors documentation maintenance throughout all phases of research and development. Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery. Selects, develops and evaluates personnel to ensure the efficient operation of the function. Actively support Regulatory Team for registration dossier preparation to achieve timely regulatory approvals and maintenance of the existing licenses in international markets. Must Have: Bachelor’s Degree in Engineering, scientific or life sciences discipline with 5 years of experience in Quality and/or Engineering OR Advanced Degree in Engineering, Science, or technical field with 3 years of experience in Quality and/or Engineering. Experience developing new pharmaceutical products and maintaining existing pharmaceutical products in a global market. Experience in Parenteral Drug development and manufacturing 3 years of experience with 21 CFR Part 211/EU GMP and other relevant current Good Manufacturing Requirements (cGMP) requirements and standards. Demonstrated audit conduct experience, including experience supporting regulatory authority inspections. Nice to Have: Prior experience managing, directing and developing people or projects 3 years of experience with pharmaceutical product development, quality by design, design verification/validation, risk management, process validation and Quality systems All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Is this is the position you were waiting for? Apply here 41037 Mirandola, Province of Modena, Italy J-18808-Ljbffr