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. 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 permanent Qualified Person supporting Finished Drug Product (FDP) certification of biologics for the EU and ROW markets. Key Duties and Responsibilities: Certification of batches of finished product to be released to the EU/EEA and ROW markets which have been manufactured and checked in accordance with its marketing authorisation, the principles and guidelines of GMP as laid down in Directive 2003/94/EC and other relevant legal requirements Familiarisation with the individual product regulatory dossiers Oversight of compliance and quality activities including Quality Risk Management, internal and supplier auditing, inspection management, records management, and change control. Collaboration with other functional areas to support new product introductions Approval of change controls, significant deviations, customer complaints and annual product quality reviews as required Ensure quality agreements are in place to support the batch certification process Act as an SME in regulatory and corporate audits Participation in the site self-inspection program by conducting audits of site functions Participation in the product recall process and BOH notification process Undergo continuous professional development including self study, site visits, internal and external training courses and participation in corporate and regulatory inspections Ensure access to the audits reports of sites involved in the manufacture and the testing of medicinal products being certified Core competencies include leadership, communication skills, teamwork, problem-solving and a commitment to compliance and continuous improvement. Qualifications, Knowledge and Skills Required: Educated to a degree level in science, engineering or related discipline with extensive experience in the biopharmaceutical/pharmaceutical industry, with a minimum of 1 years experience acting as a QP. Eligible to act as Qualified Person in accordance with the EU Guide to Good Manufacturing Practice as defined in article 51 of Directive 2001/83/EC 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-Onsite 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.