Senior Manager QA, Qualified Person

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. Competences: The (Sr) Manager, QA will report administratively and functionally to the QA Associate Director, QP. The primary role will be supporting in the implementation, organizing, managing, and execution of the Quality Assurance function and Quality Management System which will ensure product quality and compliance of relevant manufacturing and distribution activities with all regulatory and corporate requirements for the products within EU/EEA and Rest of World Markets as applicable. This position also acts as a Qualified Person as per requirements of Celgene Distribution BV license(s). Executes Qualified Person duties and responsibilities in accordance with Article 51 of Directive 2001/83/EC and Professional Code of Conduct. The Qualified Person is invested with the authority to make decisions with regards to product quality, safety, purity, and efficacy independent of other business interests. Products are for commercial and named patient supply use only. Skills/Knowledge Required: Bsc (or equivalent) in a technical or scientific discipline which and meets the EU Qualified Person educational requirements as described in Article 49 2001/83/EC in addition to any national requirements Eligible to act as Qualified Person within EC/EEA Extensive pharmaceutical quality assurance/control experience (equivalent to a minimum of 5 years experience), including audit, batch record review, change control, complaint handling and investigations experience Must have experience and good knowledge of a variety of dosage forms ideally including solids, sterile and biological products and cell therapy products Must have proven strategic thinking and contingency planning skills Must have excellent communication skills, including excellent written, interpersonal, collaboration, negotiation and dispute resolution skills, with a team oriented approach Effective planning skills and recruitment skills to identify strong performers, hire adequate members of staff and establish a high performance organization; ability to anticipate resource needs and help establish priorities. Strategic thinker who can balance near term objectives with long term goals and outcomes, evaluate risk and develop effective solutions through an integrated multi-disciplined decision-making approach. Must have excellent organizational, project management and problem solving skills Must have thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements (US and EU, particularly) Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance Must have computer proficiency Must have superior attention to detail Duties and Responsibilities: For the assigned area: As required, act as Qualified Person as per requirements of Celgene Distribution BV licenses and execute functions in accordance with Professional Code of Conduct. Fulfill Qualified Person duties as defined in article 51 of 2001/83/EC Interpret international, regional, and local regulations and apply those regulations within the GMP/GDP environment Interact with executive level employees at third party contractors Interact with Corporate and International functions as required by the tasks and responsibilities Participate in GMP- or GDP-related health authority inspections at Celgene Distribution BV and other entities as required, respond to any noted observations, and ensure implementation of corrective actions Manage quality and compliance risks by conducting risk assessments and ensuring risk mitigation actions are taken Conduct final review and approval of non-routine quality investigations related to batch deviations, batch disposition, validation activities, stability results, critical quality complaints, and other quality systems for assigned products as required Identify and recommend product and process quality improvement For non-product related duties: Support establishing and maintaining quality management system Author and/or revise standard operating procedures and associated work instructions. Review and provide recommendations on policies and standards, as required Conduct internal audits, as required Support external GMP/GDP site inspections, as required Maintain compliance with personal training requirements Assists in Quality Assurance Assessments of contractors and inputs into GMP/GDP audit program. Evaluating audit responses and reviewing corrective actions plans Disposition (release/withhold) drug product/substance batches of assigned products for distribution (or further processing) to each specific country/region of the world after confirming: Conformance to specification Compliance to regulatory/dossier requirements Acceptable deviations Act as Member of Recall Committee as required Generate, review and approve required controlled documents. As per assignment, review, edit, negotiate improvements to, and approve contractor documentation, including investigations, deviations, OOSs / Excursions Draft or review, negotiate with contractors, and recommend approval for Quality Agreements Ensure logs, databases and files related to the product quality activities are maintained 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.