Senior Specialist, Quality Compliance

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. Bristol Myers Squibb Ireland Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus. BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021. For more information about Bristol Myers Squibb, visit us at BMS.com/ie The Role BMS Cruiserath Biologics is seeking to recruit a Senior Specialist, Quality Compliance to join the Quality Systems and Compliance team for a fixed term contract of 13 months. Reporting to the Senior Manager, Quality Compliance, the Senior Specialist, Quality Compliance will be responsible for the co-ordination and execution of the Supplier Quality Management and Material Quality Management programs at BMS Cruiserath Biologics. This role some may require local/EU travel (up to 5%). Key Duties and Responsibilities: Execute, develop and maintain the Supplier Quality and Materials quality Management programs. Perform qualification activities for the suppliers and materials. Establish and maintain supplier quality agreements. Conduct supplier audits at defined frequencies, as required. Perform disposition of materials and ensure timely availability for use in manufacturing operations. Support execution of the supplier change notification program Provide quality support for Supplier non-conformance investigation. Develop the Supplier and Materials Management programs, drive efficiencies and promote best practices. Work collaboratively with the Procurement and Supplier Performance and Development organisations to drive enhanced supplier performance and reduce defect rates. Provide supplier and materials management quality support for New Product Introduction projects. Ensure completion of NPI deliverables for SAP master data builds, material qualification and material disposition. Act as a core team member of the QA Compliance team engaging in other QA compliance activities as required (e.g. internal audits, site regulatory inspections, action management etc.) Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements. Support OPEX programs and champion continuous quality improvement initiatives. Qualifications, Knowledge and Skills Required: The successful candidate will hold a BSc in life sciences or pharmacy, with a minimum 5 year’s Quality experience in a bio-pharmaceutical operations. Supplier quality and materials management experience is desirable but not essential. A clear understanding of cGMP requirements for quality systems and compliance is required. The Senior QA Compliance Specialist will be required to work on his/her own initiative in addition to working as part of a team. The candidate must be able to work across a team matrix in order to meet accelerated timelines. Excellent communication and presentation skills are essential. The successful candidate must demonstrate excellent time management and organisational skills along with a proven ability to multi-task. Operational Excellance and lean six Sigma Experience advantageous. The candidate must be able to demonstrate their ability to lead and manage projects to completion. What’s important to us Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases: Passion: Our dedication to learning and excellence helps us to deliver exceptional results. Innovation: We pursue disruptive and bold solutions for patients. Urgency: We move together with speed and quality because patients are waiting. Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments. Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues. Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential. We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve. Why you should apply You will help patients in their fight against serious diseases You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus. BMSBL
LI-Hybrid 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.