Senior Specialist, Quality Systems

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. The BMS site of Boudry is a Manufacturing Site for Oral Solid Dosage Drugs and a Center of Excellence for projects and New Product Introductions (NPIs) relying on flexible manufacturing and testing operations. The Senior (Sr.) Specialist, Quality Systems is part of the Quality Operations team of BMS Boudry, Switzerland. This position within QS & Compliance and specifically Quality Systems, is responsible to support the Boudry manufacturing site in deploying, implementing and verifying that any GMP related process and quality systems comply with the regulatory and BMS requirements. You will be acting as a Local Process Owner (LPO) or Quality System representative for the assigned Quality System (Deviation - Change Control - Risk management), as well as executing routine activities associated with Quality Systems and contributing to their continuous improvement (Systems include: Deviation, CAPA, Product Quality Complaints, Change Control, Risk Management, Annual Product Review and Data Integrity). The Sr Specialist Quality Systems can be assigned cross-functional initiatives or be involved in Global QMS alignment projects as QS site lead. The core mission is to ensure all quality aspects are efficiently and timely managed in compliance with BMS Global Processes & Policies, Standard Operating Procedures, and GMP requirements and regulations. Skills/Knowledge Required At least 5 years of experience in a pharmaceutical company or other related industry, ideally in Quality Assurance. BS or MSc in Science (Pharmacy, Chemistry, Microbiology, …) or related field. Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements. Excellent interpersonal, collaborative and organizational skills. Works independently on routine tasks, develops proposals and escalates where needed Ability to focus attention on details and to make daily routine decision. Effectively communicates internally within the function and with internal and external cross-functional teams; good written and verbal communication skills in English and French. Excellent problem-solving skills Drives continuous improvement. Knowledge of most common office software (Microsoft Office). Duties and Responsibilities Acts as site representative of the Quality Systems in global and local meetings, Community of practices or local forums. Acts as a Quality systems SME during audits and inspections. Prepares and ensures accurate quality metrics reporting for different Quality systems for Quality Council meetings and other periodic meetings. Coordinates the preparation and leads periodic system-related meetings: Investigation Review Boards (IRB), Local Change Control Board (LCRB) and Site Risk Register reviews. Coordinates the evaluation of Global change controls at local level, ensures local impact assessment of relevant changes and definition of associated action plan Supports the product quality complaints process by handling complaints (incl. complaint triage and assignment), performing investigations as assigned. Coordinates the issuance of Annual Product Quality Reviews for products manufactured in BMS Boudry. Conducts Deviation quarterly trends analysis and ensures appropriate CAPA definition in collaboration with impacted departments. Contributes to SOP revision and alignment to Global BMS requirements and provides Quality Systems training where needed Collaborate with QA Operations and QA New products introduction on quality systems improvement initiatives. Acts as a deputy for colleagues within the Quality systems team. Participate actively in the lifecycle of the strategic site Quality operation plan in cooperation with stakeholders Act as QA approver for quality records, drive change controls and /or lead projects upon requests EHS: Ensures compliance to the policy of security at work and to laws concerning health and security of the workers within the area of responsibility and ensures EHS: Promotes safe practices and behaviors, verifies that EHS rules are implemented and respected Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.