Manager, QA Laboratory Operations

Job title:

Manager, QA Laboratory 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: .Excited to grow your career?At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, haematology, 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 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.The RoleBMS Cruiserath Biologics is seeking to recruit a permanent Manager, QA Laboratory Operations, reporting to the Senior Manager, QA Laboratory Operations. The Manager will provide expert QA oversight for Quality Control Operations at BMS Cruiserath Biologics.The role will support the Global Biologics Laboratory, performing commercial finished product testing and release activities, and QC Site Operations for the manufacture of Biologic Drug Substance. In addition, the Manager will also provide quality oversight for Contract Test laboratories, Method Transfer activities and Equipment Qualification activities.Key Duties and Responsibilities

• Laboratory Investigation system owner for the Global Biologics Laboratory, QC Site Operations and Contract Test laboratories

• Manage the QC Triage business process
• Laboratory Investigations SME during regulatory agency inspections
• QA Laboratory Operations Lead at Investigations Review Board (IRB)
• Liaising with manufacturing site and/or contract laboratory for complex investigations
• QA Approver for complex/multi-functional deviations, root cause investigations, QC Laboratory investigations, impact assessments and associated CAPAs
• QA Support

• Operational SOPs, test methods, forms and directives
• Annual Product Reviews (APQRs)
• Annual Trend reports
• Laboratory equipment/instrument qualification protocols and reports
• Method validations / technical transfers protocols and reports
• QA lead for complex change controls
• QA Laboratory Operations lead supporting the QC laboratories through global regulatory agency inspections and the achievement of market approvals
• Supporting the execution of the Self Inspection programme
• Supporting QC and QA Network Harmonisation initiatives and Data Integrity programme
• Metrics champion to ensure targets are achieved and remediation plans are in place when applicable Transforming patients’ lives through science™
• Establishing best practices and continuous improvement initiatives, in collaboration with Quality Systems and Compliance, to ensure compliance of all QC activities to all applicable policies, directives, guidance documents and regulatory requirements
• Manager designee for QA huddles and at cross-functional meetings
• Supporting the hiring, development and coaching of key members of the QA Laboratory Operations team

Qualifications, Knowledge and Skills Required

• Minimum of a BSc in Science or related discipline
• 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 laboratory compliance including equipment, instrumentation and method qualification requirements
• Demonstrated in-depth knowledge of deviation and change management processes
• Ability to work on his/her own initiative in addition to working as part of a team
• Capable of positively influencing others to bring resolution to complex issues
• Ability to work across a team matrix in order to meet accelerated timelines
• Excellent written and verbal communication skills
• Excellent trouble shooting and problem solving skills as well as an ability to coach and mentor individuals or teams through complex problems
• Excellent time management & organisational skills along with a proven ability to multitask.
• Demonstrated ability to recognise issues, highlight risks and prioritise workload based on site goals

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 assurance, 27 day annual leave, life assurance and on-site gym

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.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.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, 11 Apr 2024 22:14:54 GMT

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