Manager, QA Technical Operations

Job title:

Manager, QA Technical Operations

Company

Bristol-Myers Squibb

Job description

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.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. Read more: .Bristol Myers Squibb IrelandBristol 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, 2021 and 2022.Position SummaryBMS Cruiserath Biologics is seeking to recruit a Manager, QA Technical Operations, Drug Substance. Reporting to the Senior Manager, QA Technical Operations, Drug Substance, the manager will support investigations within the Multi Product Cell Culture (MPCC) and supporting areas and act as the system owner for the Investigations process at site. The manager QA Technical Operations will also be responsible for supporting qualification and validation activities, as well as New Product Introductions (NPI) and technical transfers. The role will support Engineering, Warehouse, Facilities, Utilities and Automation activities while also providing support for SAP and Manufacturing Execution System (MES).The role will be both challenging & rewarding and will ensure that the successful candidate can seize a wide ange of development opportunities within BMS.Key ResponsibilitiesInvestigation system owner for the site with responsibility for MPCC, Warehouse, Automation, Engineering, Facility, Utility and Environmental Monitoring (EM) Investigations.Manage the Investigation triage business process and the daily investigations meeting.Support global harmonization of the investigations process through BMS network collaboration.Act as investigation process SME during Health Authority inspections.Act as QA Technical Operations Representative at Investigations Review Board (IRB) and Site Quality Council as required.Quality Approver for local and complex multi-site investigations, deviations and subsequent CAPAs, and liaising with other sites/suppliers for complex investigations when required.Site Representative at the Global investigations Community of Practice (COP) meetings and Local Process Owner (LPO) meetings.Support Implementation of Site Initiatives to prevent deviation recurrence.Promote Right First Time (RFT) approach within investigations process and drive accountability in meeting site investigation KPI’s.Act as Senior Manager designee for QA huddles and at cross-functional meetings when required.QA Lead for complex change controls, NPI and Tech Transfer Projects.QA Lead for cross-functional projects at a site level and site QA representative on global projects.Support the maintenance of Maximo, MES and SAP at BMS Cruiserath Biologics.Support site validation and qualification activities.QA review and approval of Annual Product Quality Review reports (APQRs)Support the hiring, development and coaching of key members of the QA Technical Operations team.Drive and support a culture of continuous improvement initiatives and safe working practices.Review and approval of GMP documentation, including plans, protocols, reports, SOPs, forms, directives, policies and validation documentation as required.Qualifications & ExperienceThe successful candidate must possess:BSc in Science or a related discipline, with a minimum of 5 years Quality experience in the biopharmaceutical industry.Demonstrated knowledge of applicable EU, FDA and other regulatory requirements.A strong technical aptitude, global regulatory experience and demonstrated experience interfacing with regulators.A thorough understanding of cGMP requirements for areas of responsibility.Demonstrated in-depth knowledge of deviation and change management processes.Required to work on his/her own initiative in addition to working as part of a team. Must be able of working across a team matrix to meet accelerated timelines.Capable of positively influencing others to bring resolution to complex issues.Excellent communication and presentation skills are essential.Excellent time management and organizational skills along with a proven ability to multi-task.Demonstrated ability to recognise issues, highlight risks and prioritise workload based on site goals and objectives.Excellent trouble shooting and problem solving skills as well as an ability to coach and mentor individuals or teams through complex problems.Ability to challenge the status quo with a growth mindset.Employees are expected to display the BMS values and behaviours, which enable them to be successful and perform at their highest level.If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Why you should applyYou will help patients in their fight against serious diseasesYou will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employeesYou’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical assurance, 27 day annual leave, life assurance and on-site gym#LI-HybridIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Expected salary

Location

Ireland

Job date

Thu, 17 Oct 2024 04:50:24 GMT

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