Job Details
Quality
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
The Associate Director ExM Quality Systems & Compliance will work closely with the Director ExM Quality Systems & Network Support, as well as the ExM Quality organization to provide quality systems support and build network interconnectivity with Global Quality groups. The incumbent will lead a team of local process owners; implement solutions that increase efficiency, compliance and product and process controls, that are aligned with the long-term strategy of the organization, as well as the Global Quality (GQ) strategy.
The leader will support development and maintainance of harmonized processes and controls across ExM Quality business units to obtain sustainable cGxP compliance and quality oversight for Contract Manufacturing Organisations (CMOs) for externally manufactured commercial product on behalf of Bristol Myers Squibb (BMS).
In addition, the leader will support interconnectivity across GQ and Global Product Development & Supply (GPS) sister organizations to drive alignment and consistency throughout ExM Quality, Global Quality Initiatives, Quality Management Oversight, and Quality Management Systems (QMS) integration.
The guiding principle of the role is to provide quality system expertise and support to the ExM Quality Operational towers, and efficient, optimized processes, structure, and oversight.
Key Duties and Responsibilities
Quality Systems
Quality Systems Lead a team of local process owners (LPOs) within the Quality Systems Organization for the Global ExM Operations (United States (US), Ireland (IRE), Switzerland (CH)
Ownership, oversight and implementation of Quality Systems across the Global ExM Network
Support the operational implementation of Quality Systems used withing ExM with the objective of driving consistency, efficiency and yields optimal productivity and performance for ExM allowing ExM to meet Quality objectives
Safeguard the compliance of ExM Quality Systems with applicable global regulations and internal BMS global policies and procedures
Support audits, Health Authority inspections and associated logistics when required
Drive operational excellence efforts (projects, initiatives) within ExM Quality to continuously improve and deliver greater value for ExM Quality
Implement continuous improvement efforts within ExM Quality that are coming from the broader GQ organization
Ensure evolution of systems and processes to be in alignment with changing business, industry, and market needs
Ensure ExM Quality is fully aligned with applicable external regulations and internal BMS Quality standards
Network Support
Partner with ExM Quality and Operations departments and leadership team to ensure the complete voice of the organization is represented outward within Global initiatives impacting on Quality Systems
Actively interfaces with Global Quality to ensure alignment with the GQ strategy and to ensure alignment and consistency in the GXP throughout ExM Quality, Global Quality Initiatives, Strategic Global Quality Projects, Quality Management Oversight, and QMS systems integration
Participate in development of strategies and partnerships with stakeholders within ExM Quality, ExM Operations, Global Quality Systems (GQS), Regulatory Compliance and External Engagement (RCEE), IMSQ, Strategy & Business Operations (S&BO), Product Development Quality (PDQ), Global Process Owner (GPO) and Global Process Lead (GPL) network to improve the efficiency and effectiveness of global Quality Systems
Formulate recommendations on programs that could require the commitment of significant resources that may increase or decrease facilities, equipment and personnel, which in each case must be clearly justified and adhere to prescribed regulatory and environmental requirements
People Development and Organizational Management
Develop and engage a right-sized team that can fully support ExM Quality Systems and GQ
Builds strong organizational capability for current and future needs. Recruit and develop global talent to sustain local and global competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning. Develop a high-performance culture with the ExM Quality organization
Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization
Sound influencing and negotiating experience and capabilities in a matrix environment. Must be able to interact with senior leaders in this capacity and interface with stakeholders in a matrix environment
Strategic thinker who sees the bigger picture, capable to translate the strategy into actions and possesses high business acumen; understands how the parts impact the whole (end to end enterprise) and makes the best decisions for the whole
Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures
Uses judgment to make sound decisions based on information gathered and analyzed
Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness
Action oriented and has a proven track record of delivering results.
Adapts to changing work environments, work priorities and organizational needs
Plans and organizes tasks and work responsibilities to achieve objectives. Sets priorities. Schedules activities
Enterprise Mindset
Understands the big picture, beyond their own functional area
Leads within the broader internal and external network and seeks to have impact on organization-wide performance
Embraces complexity but strives for simplicity
Shares resources and makes difficult trade-offs to benefit the organization at large
Change Agility
Creates a vision for the future by spotting strategic opportunities for breakthrough performance
Translates the case for change into actionable plans for the organization
Demonstrates smart risk-taking and personal resilience when implementing change
Enables others to navigate change with confidence and in sustainable ways
Authentic Leadership
Demonstrates an honest and unbiased understanding of their own strengths, limitations, and values
Lives up to their principles and conviction without being rigid or dogmatic
Generates trust by maintaining the highest level of consistency between their words and their actions
Talent Developer
Maintains a current and strategic view of talent management, aligned with the organization’s priorities
Understands the needs and characteristics of the organization’s talent and the extent to which it supports the business agenda
Proactively develops talent for the long and short-term, both within and outside their team
Creates a learning environment that ensures people realize their highest potential
Essential Qualifications, Knowledge and Skills
Advanced degree in science or pharmaceutical related fields (Chemistry, Pharm, Bio, Chem. Eng.) preferred
Mastery of Quality compliance processes and regulations, e.g., current Good Manufacturing Practices/Good Distribution Practices (cGMP/GDP) regulations for External Manufacturing Quality Assurance (QA)
Direct Quality Systems experience required, as well as overall understanding of manufacturing processes in the three, core, business unit platforms consisting of Active Pharmaceutical Ingredients (API), Biologics/Sterile and Non-Sterile/Packaging operations
A thorough understanding with investigation processes, product quality complaints, serialization, Corrective Action and/or Preventive Action (CAPA) management, Annual Product Quality Reviews (APQRs), audit and Health Authority inspection management, change management, and other core quality systems
A thorough understanding of global GDP regulations and requirements associated with Wholesale distribution in Ireland and Switzerland. Responsible person experience desired
A thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality investigations
A thorough understanding of technical areas related to pharmaceutical and/or biological manufacturing, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes
8 years of experience managing pharma or biopharma Quality Operations, Compliance and/or Quality Systems organizations
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.