Senior Manager Quality (Technical and Incoming QA) at Amgen in Breda

Job description

Career Category Quality Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. SENIOR MANAGER QUALITY (TECHNICAL AND INCOMING QA) At Amgen Breda, medicines are labelled, assembled, stored and shipped worldwide. More than 1,000 colleagues from 38 nationalities work across supply chain, manufacturing, marketing, sales and clinical research. Candidates must live in the Netherlands or commute to Breda. What you will do In this key role you will lead the Technical Quality and Incoming Quality teams. Their main responsibilities include managing independent oversight of commissioning, qualification and validation (CQV), computerized system validation, packaging qualification, and the inspection and release of commercial/ clinical packaging materials and products for manufacturing. You will help ensure that facilities, equipment, systems, materials, processes and records meet Amgen requirements and applicable GMP, GDP and other regulatory expectations. Key accountabilities Lead and develop the Technical Quality and Incoming Quality teams. Empower them to continuously deliver on their priorities and objectives by optimizing the capability, capacity, structure and work environment. Apply proactive talent management, succession planning, development and performance management. Ensure Quality Management System (QMS) is implemented, maintained and effective for Quality Risk Management, Facilities & Equipment Design and Maintenance and Validation. Provide independent Quality oversight ofs commissioning, qualification and validation (CQV) activities, for facility, equipment and packaging configurations as applicable. Oversee computerized system validation and data-integrity controls for systems in scope..Ensure commercial and clinical packaging materials, devices and products intended for manufacturing are inspected, sampled, dispositioned and released in line with approved procedures, specifications, sampling plans and regulatory requirements. Oversee the investigation and escalation of incoming-material deviations. Coordinate supplier-related Quality issues with Supplier Quality and Procurement. Guide Manufacturing, Warehouse, Supply Chain, Engineering, Technology, Validation and other operational partners on Quality decisions, balancing compliance, patient protection and supply continuity. Define and track meaningful Quality and performance metrics, report trends and risks, and lead sustainable improvement actions. Prepare for and lead regulatory inspections, and participate in internal, supplier and partner audits. Drive timely, robust responses and follow-through on observations within scope. Work with Corporate and network Quality colleagues to share learning, harmonize practices and implement new regulatory expectations. As a member of the ABR Quality Management Team, contribute to setting and implementing the local Site Quality strategy and goals, and support the ABR Quality team in meeting its priorities. Provide broader Quality leadership cover when needed. Leadership and decision-making scope Translate the