Job Information
Bristol Myers Squibb Senior Manager, Qualified Person Drug Substance 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 produces 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 to support Biologic Drug Substance Manufacture and Release and provide .
Reporting to the Associate Director, QA Operations for Biological Drug Substance Manufacture, the Qualified person will be responsible for the certification of finished Drug Substance, coordination of intra- and inter-departmental activities that allow the batch certification and provide quality oversight during Tech Transfer, NPI and analytical method transfer and during routine manufacture and analytical testing.
Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.
Key Responsibilities
Confirmation that 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 authorization, the principles and guidelines of GMP as laid down in Directive 2003/94/EC and other relevant legal requirements.
Provide support for commercial and clinical manufacturing operations and testing in support release activities as they pertain to commercial and clinical drug product.
Coordination of activities across the QA Batch Review Team and all other departments responsible for actions impacting on batch certification activities
Provide Quality Oversight to NPI, Technology Transfer and Analytical Method Transfer teams at site and ensure requirements for clinical projects/ conditional movement/ disposition requirements are included as part of project planning
Approval of change controls, significant/ complex deviations/ deviation trend reports/ APQRs/ EM Trend Reviews as required.
Provide Quality Oversight at Quality/ Manufacturing/ Environmental Programme/ QC Analytical tiered meetings as required.
Oversight of Quality Agreements in support of batch certification process
Provide SME support in regulatory and corporate audits. Participate in site self-inspection program though conducting audits of site functions.
Represent CRU disposition at Global forums and maintain relationship with Supply Chain and GCH
Establishing best practices and continuous improvement initiatives, in collaboration with Quality Systems and Compliance, to ensure compliance of operational activities to all applicable policies, directives, guidance documents and regulatory requirements.
Participation in the product recall process and Board of Health notification process.
Qualifications & Experience
Eligible to act as a QP in accordance with EU Guide to Good Manufacturing Practice
The successful candidate must possess a Bachelor/Masters in Engineering, or Science related discipline with a minimum of 8years experience in the biopharmaceutical/ pharmaceutical industry, with a minimum of 1 years experience acting as QP.
Ability to make decisions and align a target audience with the decision taken
Core competencies must include leadership, communication and a commitment to compliance and continuous improvement.
Must be a proficient communicator and collaborator comfortable in collaboration at all company levels an across divisions
Proven success working well within a team environment with a flexibility to react to changing business with demonstrated problem solving and project management skills
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-Hybrid
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: R1582919
Updated: 2024-07-01 04:14:08.202 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.