Manager, Quality Systems

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 a permanent Contract Manager, Quality Systems, reporting to Director, Quality Systems & Network Support Global Quality Operations Org.

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:

Process Ownership
The Quality Systems Manager will act as end-to-end Local Process Owner of one or more Quality Systems used within Global External Manufacturing
Establish and maintain relationships and communication pathways with Global Process Owners and Global Process Leads for relevant systems
Act as primary ExM representative at Global Community of Practice meetings
Gather stakeholder input from within ExM on any Global Process changes or initiatives and represent the input back into the Global Network
Own all elements of the process including relevant procedures / forms, training materials, SharePoint content, metrics where applicable
Display technical knowledge of the process and understand risks/weaknesses in the system
Responsible for ensuring the elements of the process are compliant with Regulatory requirements, Health Authority expectations and with Bristol Myers Squibb (BMS) policies / global procedures where applicable
Responsible for ensuring the elements of the process are current and reflect current practices
Be primary subject matter expert for review of regulatory changes, responsible for coordination of input from key stakeholders into the impact assessment to the process
Ensure appropriate Key Performance Indicators are in place to measure the effectiveness of the system within ExM
Regularly review the process (trends metrics, trends observations, right first time (RFT), Design, optimisation) for their effectiveness and provide feedback to the Quality management team for action and remediation
Own relevant process issues – speak to trends / issues / exceptions at External Manufacturing Tier 3A and 3B Quality Council.
Own Health Authority commitments related to the process
Act as the subject matter expert in audits / inspections
Develop and implement pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillance
Processes include Deviation Investigations, Corrective Action / Preventive Action (CAPA), Complaints, Change Control, Quality Risk Management, Documentation, Training, Audits & Inspections.

Operations Support
The Quality Systems Manager will be responsible for providing day-to-day support to ExM Operations on Quality Systems that enable business objectives to be achieved. This may include:Processing of Customer Complaint records, including escalation of expedited complaints
Support the processing of deviation investigations, CAPAs and change controls
Perform initial impact assessment of Global change controls that may impact ExM Operations
Participate in Virtual Plant Team (VPT) meetings as appropriate
Support the risk assessment and mitigation plans of Contract Manufacturing Organizations (CMO), as required
Facilitate tracking of CMO Health Authority inspection observations and CAPAs
Escalate any emerging trends / issues to the VPTs, as required.
Provide Quality input ad hoc queries relating to ExM Operations

Support metrics collection and processing, including:Capture and report on Quality data and metrics for management review and other organizational forums
Utilize data analysis or software skills to build on existing tools to improve the quality system processes
Collect statistical data and compile data for reports; update and assure the accuracy of databases; create management reports; collect, compile, and analyse data and information

Other ad-hoc duties will be required which will include, but not be limited to, the following:Act as team lead for coordinator of work associated with complaints, change control, deviation, CAPA and document management in the applicable ExM location
Author, review and approve Quality Management System (QMS) documents
Process QMS documents in the electronic document management system
Participate in and support Permanent Inspection Readiness activities
Maintain the Quality Risk Register for ExM
Monitor the periodic review of Quality Systems documents
Maintain the system and process for record management
Maintain the system for update of ExM GxP (Good Practice) Authorizations
Act as facilitator and reviewer of global procedural updates through the GPO network
Act as ExM Quality Systems representative on ExM and Global Quality projects
Support the scheduling, execution, reporting, follow up and tracking of self-inspections audits
Support preparation of and participate in Quality Council meetings
Perform self-inspection audits as part of the audit team
Review regulatory inspection observations from other BMS sites for site compliance
Identify and implement continuous improvement opportunities for Quality Systems owned processes
Act as qualified training for Quality Systems owned processes

Qualifications, Knowledge and Skills Required:
A science related degree in Chemistry, Engineering or Biotechnology or equivalent
A minimum of seven (7) years' experience in a pharmaceutical Quality related role, preferably within a Quality Systems team
A strong working knowledge of GxP regulations in the European Union (EU), United States (US) and other relevant global markets
Knowledge of OPEX tools
Experience in leading or participation in project teams
Works under minimum supervision and exhibits a positive work attitude and high productivity
Detail-oriented, well organised and have excellent verbal and written communication skills as well as excellent organization and follow-up skills
Candidate must be 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 are required; self-motivated
Strong presentation skills; confident public speaker
Ability to multi-task numerous projects
Ability to achieve targets and milestones
Can prioritize workload based on changing business needs
Ability to recognize topics / decisions requiring escalation
Ability to work with initiative and manage own workload
Proficient in the use of Microsoft Office programs including OneNote and SharePoint platforms
Fluent English is required. For roles based in Switzerland, French is also desired.
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.

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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries ******. Visitcareers.bms.com/eeo-accessibilityto 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:https://careers.bms.com/california-residents/

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