Senior Manager, Qualified Person

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 and 2021.  

For more information about Bristol Myers Squibb, visit us at BMS.com/ie

The Role

BMS Cruiserath Biologics is seeking to recruit on a permanent contract, a 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 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, Knowledge and Skills Required:

• 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, but not only, an annual bonus, pension contribution, family health insurance