Job Information
Bristol Myers Squibb Senior Manager, Qualified Person, QP Operations in Cruiserath, Ireland
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: careers.bms.com/working-with-us .
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, 2021 and 2022.
Position Summary
BMS Cruiserath Biologics is seeking to recruit a Qualified Person supporting Finished Drug Product (FDP) certification of biologics for the EU and ROW markets.
Key Responsibilities
Certification of batches of finished product to 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.
Ensure any deviations have been documented and approved in accordance with the defined procedure.
Ensure that any changes requiring a variation to the marketing or manufacturer's authorisation have been approved by the regulatory authority.
Provide quality and compliance guidance on critical and major quality matters.
Develop and maintain QP oversight procedures for both internal and CMO sites to continually support the QP function.
Possesses an excellent understanding of cGMP and Quality Risk Management principles.
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 and quality oversight activities.
Act as an SME in regulatory and corporate audits.
Participation in the product recall and/or Health Authority notification processes, as required.
Maintain an up-to-date knowledge of pharmaceutical legislation and industry practice.
Collaboration with other functional areas to support new product introductions.
Core competencies include strong decision making, leadership, communication, teamwork and problem-solving skills.
Qualifications & Experience
Educated to a degree level in science, engineering or related discipline with a minimum of 8 years experience in the biopharmaceutical/pharmaceutical industry.
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.
Experience as an acting QP named on a Manufacturer's Authorisation is an advantage.
Experience in manufacture of biological products and/or aseptic manufacturing would be beneficial.
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, 27 days of annual leave, life assurance and on-site gym
#LI-Onsite
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 Protocol
BMS 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 adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility 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.
Company: Bristol-Myers Squibb
Req Number: R1582927
Updated: 2024-06-30 03:46:45.282 UTC
Location: Cruiserath-IE
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.