Job Details

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.

Ireland is home to External manufacturing’s global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO’s) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network.

This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites. In Ireland, External Manufacturing has two sites; Global Headquarters based in Dublin 15 and a distribution centre in Shannon, Co Clare.

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

The Role

BMS External Manufacturing is looking to recruit on a permanent Contract Senior Manager, QA Lead - QP Operations Pharmaceutical Quality, reporting to Director, Pharma QP Operations Global Quality External Manufacturing and Supply Chain.

The QA Lead – QP Operations (Pharma) will provide technical leadership and guidance to the QP Disposition Specialists and Managers on SFDP and FDP QP pack preparation in the pharma organisation.  They will have responsibility for working with stakeholders such as internal sites, external VPTs and supply chain planners to co-ordinate activities within the QA function of the QP team to ensure the efficient operation of the QP team as a whole.  They will also be involved in assisting in the activities related to Batch Certification of Bulk, primary packed and Finished Drug Product at Plaza 254 and Utrecht in accordance with cGMP regulations.

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 Duties and Responsibilities:

• Support the Qualified Person with the Batch Certification function
• Manage a team of Quality Specialists and managers to ensure that batch certification lead times are consistently met
• Facilitate preparation and review of batch documentation packages for QP release as per SOP requirements
• Communicate and collaborate with BMS Supply Chain to support QP release schedule, as required
• Develop, prepare, and report Quality Metrics
• Co-ordinate activities associated with new product introductions
• Authoring, review and approval of QA-related procedures and relevant controlled documents.
• Provide training to new team members, as required
• Support the site inspection readiness program for corporate and regulatory inspections and act as SME, when required
• Preparation of quality documents supporting batch certification e.g., QP declarations, Product Quality Reviews and Risk Assessments
• Act as functional lead for QMS activities e.g., Change Control assessments, Investigations and Quality Agreement updates.
• Perform additional team tasks as agreed to support effective running of the function
• Support Opex programs and champion continuous quality improvement initiatives
• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.

Qualifications, Knowledge and Skills Required:

• BSc in Science or related discipline with 5-7 years QA experience in a pharmaceutical environment, preferably Operations based.
• A clear understanding of cGMP requirements for manufacturing and/or systems and compliance
• Demonstrated proficiency communicating and collaborating at a variety of levels and across divisions
• Demonstrated ability to recognise issues, highlight risks and prioritise workload based on schedule requirements
• Proven success working well in a team environment with flexibility to react to changing business needs

• In addition to the BMS Core behaviours, the job holder should exhibit;
• Good interpersonal, oral, and written communications skills.
• The Manager must demonstrate an ability to coach and mentor others, as well as be able to prioritise objectives from multiple projects.
• Excellent communication and ability to contribute to and lead team based in collaborative environment is essential.
• Proactive in resolving issues and escalating to management when necessary
• Must lead by example in terms of displaying the BMS behaviours

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, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance.

BMSBL

#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.