Executive Director, Compliance Enabling QMS

5 months ago

Dublin, Ireland Bristol Myers Squibb Full time

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.

Position Summary

Reporting to the Vice President, Corporate Quality, this role is primary responsible for the development, management and oversight of the End-to-End Quality Management system inclusive of R&D Operations and Global Pharmaceutical Sciences driving compliance at the site and functional levels across all GxP areas covering cell therapy, biologics and small molecules. Additional ownership of core quality systems including Investigation, Deviation, CAPA Management, Change Control, Risk Management, Audit/Inspection, Training, and other quality system processes, as needed. Responsible for continuous improvement cycles relates to the QMS and ensuring capabilities of the business to implement the QMS.

Key Responsibilities

Responsible for implementing and maintaining The Quality Management System (QMS) across R&D and GPS ensuring continuous improvement for the associated Quality Systems and implementing strategy at the enterprise level.

Ensures adherence to phase appropriate cGxP compliance requirements, in compliance with FDA, EU and global regulations and ICH guidelines.

Effectively collaborates with sites and functions across the company to analyze and resolve issues in accordance with appropriate quality standards ensuring a fit for purpose model across the enterprise.

Stay informed of evolving regulatory requirements and industry trends related to quality management systems, and proactively assess their impact on the organization. Define, enhance and maintain GPO network to drive strategic GPS objectives.

Support BMS M&A activities by ensuring alignment across the QMS framework

Foster a culture of quality excellence by promoting awareness, training, and engagement across the organization, emphasizing the importance of quality in all aspects of our operations.

Collaborate with senior leadership to develop and execute quality strategies that align with business objectives and drive continuous improvement in quality performance.

Qualifications & Experience

Bachelor’s Degree or equivalent education and 15+ years of experience. Master’s degree preferred.

Must have experience working in the pharmaceutical industry with the FDA, EMEA and preferably multiple additional regulatory agencies in other foreign countries. Experience working in Regulatory Law is a plus.

Must have experience working at an enterprise level engaging with executive business leadership. Plant/site experience is also desired.

Profound understanding of international GxP regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, WHO).

Quality operational experience to ensure understanding of key business quality and compliance drivers of the Pharmaceutical Industry.

Strong communication, negotiation, problem solving and interpersonal skills.

Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk.

Demonstrated change agility and leading others through change and ambiguity.

Ability to provide innovative ideas or alternatives that create competitive advantages across enterprise

High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams.

Demonstrated ability to work effectively in a matrix environment and drive results through "influence" as well as direct management.

Demonstrated Enterprise mindset to be able to think and act across functions and divisions.

#LI-HYBRID

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 . 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

  • Director, Payment Integrity Product Enablement and Delivery

    3 months ago

    Dublin, Ireland UnitedHealth Group Full time

    Director, Payment Integrity Product Enablement and Delivery- Dublin or Letterkenny/ Hybrid Optum is a global organisation that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they...

  • QA/Compliance Lead

    1 month ago

    Dublin, Ireland Zoetis EUAFME Full time

    This position reports to the Site Quality Lead and will serve as the Quality Compliance and Product Release Resource for the Tallaght Site. The position will serve as a partner alongside other stakeholders to enable site objectives by meeting quality objectives. The Tallaght QA/Compliance Lead will be the system owner for Validation Compliance, Product...

  • Director, Integrated Execution- Europe Flexible

    3 months ago

    Dublin, Ireland Coca Cola Full time

    Description Summary: At the Coca-Cola Company, we are a center of excellence who work collaboratively to find new and innovative ways to strategically move the business forward by leading, developing, and executing digital strategy throughout our customer and Bottler relationships. We’re looking for candidates to make an impact for some of the most...

  • Compliance Executive

    1 month ago

    Dublin, Ireland Eirkoo Full time

    Role Purpose: Our client a fast growing financial services/MIFID company based in Dublin, are looking to hire a compliance executive. The role offers excellent exposure to someone looking to develop their career further. It is a wide-ranging and highly-rewarding role covering various aspects of the Companys compliance and risk frameworks. Role...

  • Senior Quality Specialist

    6 months ago

    Dublin, Ireland West Pharmaceutical Services Full time

    At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and...

  • Senior Sales Enablement Specialist

    1 week ago

    Dublin 1, Ireland Semrush Full time

    Hi there!We are Semrush, a global IT company developing our own product – a platform for digital marketers. New stars are born here, so don’t miss your chance.Semrush is seeking a Senior Sales Enablement Specialist to support our sales team. The perfect candidate will possess a strong “marketing technologist” mindset, with a background in pre-sales...

  • HSE & Compliance Manager / Dublin West

    1 month ago

    Dublin, Ireland Executive Edge Full time

    Health, Safety, Environmental and Compliance Manager / Dublin Based with some travel Our client is a leading group of technology distribution, supply chain services, and technology solutions businesses headquartered in Dublin, Ireland. Their focus is on providing high-quality services, innovative solutions, and maintaining the highest standards of health,...

  • Director of AML and MLRO

    1 month ago

    Dublin, Ireland Cpl Resources Full time

    My client is seeking an experienced financial crime professional to serve as Director of AML and MLRO for their Dublin entity, reporting to the European Head of Compliance, on a functional basis, and to the CEO on a local basis.This person will drive and lead a dynamic technology-driven AML compliance function at both a local and European level and have...

  • Global Director of HR Technology

    1 month ago

    Dublin, Ireland Sanderson Recruitment (Ireland) Limited Full time

    HR Technology and Operations Director The Global HR Technology & Operations Director will drive the execution of our established global HR technology strategy (e.g., SAP SuccessFactors, LMS, Time and Attendance, Payroll, Survey Tools, etc.), ensuring alignment with key stakeholders across regions. This role will focus on addressing system gaps, implementing...

  • Director, Business Processes

    2 months ago

    Dublin, Ireland UnitedHealth Group Full time

    Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data, and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion,...

  • Director, DDI

    2 weeks ago

    Dublin, Ireland TD Global Finance Unlimited Company Full time

    Description The TDS Data, Delivery & Integration (DDI) group enables efficient and effective program delivery of the dealer's major, cross-functional initiatives. We're an innovator and leader in the change management space. Our legendary customer & colleague experience continues to guide us as we deliver enhanced technology, process, and capabilities...

  • Health, Safety, Environmental

    1 month ago

    Dublin, Ireland Executive Edge Full time

    Health, Safety, Environmental and Compliance Manager / Dublin Based with some travel Our client is a leading group of technology distribution, supply chain services, and technology solutions businesses headquartered in Dublin, Ireland. Their focus is on providing high-quality services, innovative solutions, and maintaining the highest standards of health,...

  • Head of Risk

    3 weeks ago

    Dublin, Ireland Abrivia Full time

    Role: Head of Risk & Compliance Location: Dublin West Head of Risk & Compliance wanted for Financial Services Group-Dublin West Abrivia are currently recruiting for a Head of Risk and Compliance (PCF 12 and PCF 14) to join our client, the Financial Services arm of a Global Organisation based in Dublin West. With a solid compliance and risk framework already...

  • Director, Private Equity

    4 weeks ago

    Dublin, Ireland HedgeServ Full time

    HedgeServ is a leading global fund administrator with more than $450 billion in assets under administration across all investment vehicles including Hedge Funds, Private Equity Funds, UCITS, Hybrid Credit Managers, Funds of Funds and Managed Account Platforms. We optimize our clients’ experience using unique proprietary technology coupled with robotic...

  • QA Specialist, Compliance

    3 months ago

    Dublin, Ireland West Pharmaceutical Services Full time

    Job Summary : In this role the Quality Specialist, Compliance is responsible for maintaining the ongoing compliance of the Quality Management System. Quality Specialist, Compliance is responsible for the administration of the Document Management system on site including coordination of all document change request activities for their nominated area of...

  • Compliance Manager

    3 weeks ago

    Dublin, Ireland Sigmar Recruitment Full time

    Regulator of the National Lottery (ORNL) - Compliance Manager (Higher Executive Officer) | Public Sector | Dublin City Centre | €57k Sigmar Recruitment is working in conjunction with the Regulator of the National Lottery (ORNL) to recruit a Compliance Manager. The Compliance Manager will play a key role in assisting the Head of Legal and Compliance in...

  • Corporate Tax Compliance Senior

    4 months ago

    Dublin, Ireland Deloitte Ireland LLP Full time

    Deloitte is the biggest professional services Firm in the world and making an impact is more than just what we do: it's why we're here. We're driven to create positive progress for our clients, community, people, and the planet. This sense of purpose inspires us to work to the highest standards, to tackle the challenges that matter. The tax landscape is...

  • Compliance Manager

    3 weeks ago

    Dublin, Ireland Self Help Africa Full time

    Job Title: Compliance Manager Organisation: Self Help Africa (SHA) Location: Dublin, Ireland (Hybrid working arrangements) Contract type:Full time / Permanent Hours:37.5 hours per week, Monday to Friday Reports to: Director of Business Services About Self Help Africa Self Help Africa is an international development organisation that works through agriculture...

  • Executive Support Specialist

    2 weeks ago

    Dublin, Ireland Lex Consultancy Full time

    Location:  Dublin 2, Ireland – with a blend of in-office and remote work flexibility. Salary:  €50,501 per annum Contract:  12-month contract, with potential future opportunities. Application Deadline: 9AM on Friday, November 22, 2024 We are seeking dynamic Executive Support Specialists to join a high-profile organisation and provide...

  • Executive Assistant

    1 month ago

    Dublin, Ireland Lex Consultancy Ltd Full time

    A dynamic and experienced Executive Assistant is required for a large Professional Services organisation. This is a really exciting opportunity to directly support the Director of the HR Department, providing them with daily administrative support in managing their diary, correspondence and events. In addition, you will be a key administrator to the HR Team,...