Manager, Quality Operations Drug Product, QP Team

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. 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: 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 manufacturings global headquarters the business unit responsible for the management of manufacturing contract operations (CMOs) 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 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 Role

BMS External Manufacturing is looking to recruit on a Fixed Term Contract Manager Quality Operations Drug Product QP Team reporting to Senior Manager QA Lead Pharma QP Operations

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
Prepare 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
Completeactivities 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.

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 prioritise objectives from multiple projects.
Excellent communication and ability to contribute to 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

QualificationsKnowledge and Skills Required:

BSc in Science or related discipline with 2-3 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
QP Eligible (Desirable)

Why you should apply

• You will help patients in their fight against serious diseases
• You willbe part ofa company that encourages excellence and innovation respects diversity develops leaders and values its employees.
• Youll 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

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If you come across a role that intrigues you but doesnt 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 a supportive culture promoting global participation 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 an 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.

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