Quality Unit Business Process Specialist - Drug Substance

Business Introduction: We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. Position Summary: Join us as a Quality Unit Business Process Specialist supporting drug substance operations at a United States site. You will collaborate daily with manufacturing, quality, IT, and engineering teams to ensure quality processes run smoothly and compliantly. Your role will focus on overseeing quality systems, identifying improvement opportunities, and coaching colleagues to maintain high standards. We value practical problem-solvers who know how to communicate clearly and take ownership. This role offers visible impact, continuous learning, and career growth as you contribute to our mission of uniting science, technology, and talent to get ahead of disease together. Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: • Provide quality oversight for drug substance-related business processes and systems, ensuring compliance with regulations and internal standards. Act as a key quality contact for cross-functional teams and sites on master data, process changes, and procedural questions. Develop, review, and maintain quality unit business process documentation and standard operating procedures (SOPs). • Support investigations, root cause analysis, and corrective and preventive actions related to quality deviations and process issues. • Facilitate quality impact assessments and risk reviews for process and system changes. Train and coach site colleagues on quality processes, documentation practices, and compliance requirements. Basic Qualifications: • Bachelor’s degree in life sciences, engineering, quality, or a related technical field. Minimum 3 years’ experience in cGMP production, quality control, or quality assurance in a regulated life sciences environment. Experience designing, implementing, or supporting quality business processes, preferably involving SAP or similar ERP. • Practical knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and regulatory compliance. Experience participating in change control, CAPA, deviations, or quality investigations. Strong verbal and written communication skills and ability to work collaboratively on-site with cross-functional teams. Preferred Qualifications: • Experience in pharmaceutical or biologics manufacturing environments, particularly with computerized manufacturing systems. Familiarity with laboratory information management systems (LIMS), Manufacturing Execution Systems (MES), or electronic batch records. • Formal training or experience in structured root cause analysis and risk assessment techniques. Proven ability to influence and coach colleagues at different levels and from multiple disciplines. Experience maintaining inspection readiness and supporting regulatory audits. Demonstrated focus on continuous improvement through monitoring o