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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

The Quality Systems and Compliance organization within Global External Manufacturing (ExM) is seeking to recruit a Quality Systems Manager for its Dublin-based operations. The successful candidate will be responsible for implementing, supporting, and monitoring the effectiveness of Quality Systems and Training within ExM.

Key Duties and Responsibilities

Process Ownership

The Quality Systems Manager will serve as the end-to-end Local Process Owner for one or more Quality Systems utilized within ExM. Processes include Deviation Investigations, Corrective Action/Preventive Action (CAPA), Complaints, Change Control, Quality Risk Management, Documentation, Training, Audits & Inspection. Activities may include:

• Establishing and maintaining relationships and communication pathways with Global Process Owners and Global Process Leads for relevant systems

• Acting as the primary ExM representative at Global Community of Practice (COP) meetings

• Gathering stakeholder input from within ExM on any Global Process changes or initiatives and presenting this input to the Global Network

• Owning all elements of the process, including relevant procedures/forms, training materials, SharePoint content, and metrics where applicable

• Displaying technical knowledge of the process and understanding risks/weaknesses in the system

• Ensuring that all elements of the process are compliant with regulatory requirements, Health Authority expectations, and Bristol Myers Squibb (BMS) policies/global procedures where applicable

• Ensuring that all elements of the process are current and reflect current practices

• Serving as the primary subject matter expert for the review of regulatory changes, coordinating input from key stakeholders into the impact assessment of the process

• Ensuring appropriate Key Performance Indicators (KPIs) are in place to measure the effectiveness of the system within ExM

• Regularly reviewing the process (including metrics trends, observation trends, right-first-time (RFT) rates, design, and optimization) for effectiveness and providing feedback to the Quality management team for action and remediation

• Owning relevant process issues and addressing trends, issues, and exceptions at External Manufacturing Quality Council meetings

• Owning Health Authority commitments related to the process

• Serving as the subject matter expert during audits and inspections

• Developing and implementing proactive continuous improvement plans for the process, such as Value Stream Mapping, identifying weak elements, and conducting regulatory surveillance

Operations Support

The Quality Systems Manager will provide comprehensive support to ExM Operations on Quality Systems-including Deviation Investigations, Corrective Action/Preventive Action (CAPA), Complaints, Change Control, Quality Risk Management, Documentation, Training, and Audits & Inspections-to ensure the achievement of business objectives. Tasks may include:

• Processing Customer Complaint records, including the escalation of expedited complaints

• Supporting the processing of deviation investigations, CAPAs, and change controls

• Performing initial impact assessments of Global change controls that may affect ExM Operations

• Participating in Virtual Plant Team (VPT) meetings as appropriate

• Supporting the risk assessment and mitigation plans of Contract Manufacturing Organizations (CMOs), as required

• Facilitating the tracking of CMO Health Authority inspection observations and CAPAs

• Escalating any emerging trends or issues to the VPTs, as required

• Providing Quality input for ad hoc queries related to ExM Operations

• Supporting the collection and processing of metrics, including capturing and reporting Quality data for management review and other organizational forums. This involves utilizing data analysis and software skills to enhance existing tools and improve quality system processes (Activities include collecting statistical data, compiling information for reports, updating and ensuring the accuracy of databases, creating management reports, and analyzing data and information)

• Leading and coordinating work related to complaints, change control, deviations, CAPA, and document management at the applicable ExM location

• Authoring, reviewing, and approving Quality Management System (QMS) documents

• Processing QMS documents in the electronic document management system

• Participating in and supporting Permanent Inspection Readiness activities

• Maintaining the Quality Risk Register for ExM

• Monitoring the periodic review of Quality Systems documents

• Managing the system and processes for record management

• Overseeing the system for updating ExM GxP (Good Practice) Authorizations

• Facilitating and reviewing global procedural updates through the GPO network

• Serving as an ExM Quality Systems representative on ExM and Global Quality projects

• Supporting the scheduling, execution, reporting, follow-up, and tracking of self-inspection audits

• Assisting in the preparation for and participation in Quality Council meetings

• Performing self-inspection audits as part of the audit team

• Reviewing regulatory inspection observations from other BMS sites for site compliance

• Identifying and implementing continuous improvement opportunities for Quality Systems-owned processes

• Acting as a qualified trainer for Quality Systems-owned processes

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.

Essential Qualifications, Knowledge and Skills:

• A science-related degree in Chemistry, Engineering, Biotechnology, or a related field, or equivalent experience

• A minimum of seven (7) years of experience in a pharmaceutical quality-related role, preferably within a Quality Systems team

• Strong working knowledge of GxP regulations in the European Union (EU), United States (US), and other relevant global markets

• Familiarity with Operational Excellence (OPEX) tools

• Experience in leading or participating in project teams

Preferred:

• Experience in a GxP manufacturing site

• Training or qualification in technical writing

• Lead investigator training

• Qualified auditor

• Lean Six Sigma certification

• Project management certification

Personal Competencies Desired/Required :

• Works under minimal supervision, exhibiting a positive work attitude and high productivity

• Detail-oriented, well-organized, and possesses excellent verbal and written communication skills, as well as strong organizational and follow-up abilities

• Flexible and comfortable working in a fast-paced environment with aggressive and dynamic timelines

• Excellent interpersonal skills

• Ability to collaborate, facilitate, and support standard practices across multiple functional groups in diverse geographical locations; self-motivated

• Strong presentation skills and confident public speaker

• Capable of multitasking across numerous projects

• Ability to achieve targets and milestones

• Can prioritize workload based on changing business needs

• Ability to recognize topics and decisions requiring escalation

• Able to work with initiative and manage own workload

• Proficient in the use of Microsoft Office programs, including OneNote and SharePoint platforms

• Strong working knowledge of Microsoft Office

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

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: R1582880

Updated: 2024-06-30 03:46:45.300 UTC

Location: Dublin-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.