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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 Fixed Term (2 years) Contract Manager, Regulatory Operations , reporting to the Senior Manager, Regulatory Operations. The Regulatory Operations Manager is responsible for all regulatory support activities within External Manufacturing to ensure that the manufacture of products by Contract Manufacturing Organizations (CMOs) is aligned with the appropriate regulatory dossiers.

Key Duties and Responsibilities:

• Develop and manage appropriate business processes to support Regulatory Dossier Management for products supported by External Manufacturing

• Manage the notification of Change Control approvals and regulatory renewals to CMOs as appropriate, to ensure that the CMO has the most up-to-date regulatory dossiers

• Manage a process to ensure appropriate batch restrictions are applied in the case of change controls where regulatory approvals are required

• Manage regulatory documentation requests to support filings, updates, annual reports renewals and Health Authority (HA) requests

• Review relevant Chemistry, Manufacturing and Controls (CMC) sections of new drug applications (NDA’s) and market authorisation applications (MAAs) and provide support for filings

• Provide Good Manufacturing Practice (GMP) and Regulatory training as required

• Participating in other Quality Assurance (QA) supporting activities as required (e.g. internal audits, site regulatory inspections, Annual Product Quality Reviews (APQR’s), quality risk management).

• Manage the follow-up and close out of regulatory actions associated with External Manufacturing (ExM) Change Controls

Qualifications, Knowledge and Skills Required:

• In-depth understanding of the International Regulatory Requirements for new market authorizations and post-approval

• Business Knowledge/understanding of External Manufacturing.

• Leadership and Management Skills

• Excellent communication skills

• Understanding of current Good Manufacturing Practice (cGMP) principles pertaining to Active Pharmaceutical Ingredients (API) and Drug Product pharmaceutical manufacture

• Demonstrates expert knowledge of Food and Drug Administration (FDA), International Council of Harmonisation (ICH) and BMS corporate cGMP policies and guidelines

• Ability to manage cross functional projects and meet tight timelines/deadlines

• Strong Technical writing ability

• Openness to change, receptive to new ideas

• BSc / MSc in chemistry or related disciplines

• Preferable to have five (5) years’ experience in QA and one (1) year in a regulatory environment

• Knowledge / appreciation of other site operations such as Quality Control (QC), Materials, Manufacturing Technology (MT) and manufacturing

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-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/ (https://careers.bms.com/eeo-accessibility) 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: R1580253

Updated: 2024-05-04 01:22:13.806 UTC

Location: Dublin-IRL

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.