Quality Risk Assessment Lead

Job title: Quality Risk Assessment Lead

Company: Johnson & Johnson


Job description: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.comJob Function: Supply Chain ManufacturingJob Sub Function: Manufacturing Process ImprovementJob Category: ProfessionalAll Job Posting Locations: Schaffhausen, SwitzerlandJob Description:About Innovative MedicineOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.Learn more at#Li-HybridWe are searching for the best talent for Quality Risk Assessment Lead to be in Schaffhausen.Purpose: Are you passionate about ensuring quality and product safety in pharmaceutical manufacturing? Join our dynamic team as the Quality Risk Assessment Lead for the Business Unit Parenterals! In this new pivotal role, you will drive the effective application of risk assessment tools while leading risk characterization activities that strenghten our production processes. Your contributions will be vital in assessing risks and shaping and initiating risk reduction measures that meet health authority requirements and internal regulatory standards. You will work in a cross-functional team to maintain high standards of quality and compliance in the Business Unit Parenterals.You will be responsible for:

• Conducting periodic reviews of existing risk assessments to ensure ongoing compliance and enhancement.
• Collaborate with project teams to prepare risk assessments in line with established guidelines.
• Support ongoing risk re-evaluations to adapt to current requirements.
• Generate essential documentation to support our risk management strategies.
• Contribute your expertise to non-conformance investigations, identifying risks and outlining corrective and preventive actions (CAPAs).
• Partner with the Quality Risk Management Process Owner and cross-functional teams to develop effective risk management frameworks.
• Deliver training focused on risk management to the Parenterals business unit.
• Serve as a Subject Matter Expert in quality risk assessment.
• Foster close collaboration with production teams and other key business partners.
• Adhere to Good Manufacturing Practices (GMP), Environmental, Health and Safety (EHS), and Sarbanes-Oxley (SOX) guidelines.

Qualifications / Requirements:

• You hold at least a bachelor’s degree in natural science or engineering; a master’s degree is preferred.
• You bring over 2 years of experience in the pharmaceutical industry, particularly in parenteral manufacturing or development roles.
• You possess exceptional verbal and written communication skills, with a knack for influencing across diverse teams and leadership levels.
• You have a solid understanding of manufacturing site systems and procedures.
• You are a natural leader and agent of change, ready to take initiative and drive improvements.
• Proficiency in both German and English is essential.
• You thrive in an independent work environment and have proven problem-solving capabilities.

Why Join Us?Become part of a forward-thinking company committed to excellence in pharmaceutical manufacturing. In this role, you will have the opportunity to work in a collaborative environment, contribute to meaningful projects, and make a lasting impact on quality and compliance in our processes. We look forward to welcoming you to our team!

Expected salary:

Location: Schaffhausen

Job date: Mon, 07 Apr 2025 04:46:59 GMT

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