Senior 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 Fixed Term Contract (12 months) Senior Manager, Quality Systems, reporting to Associate Director, Quality Systems.

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:

The Quality Systems Senior Manager is responsible for ensuring the effective implementation of Quality Systems and Training within the Global External Manufacturing organization.

Manage People

• Provide regular feedback and coaching to reports
• Develop direct reports through coaching, mentoring, training and providing them with development opportunities
• Build a team culture committed to high performance
• Build effective working relationships both internally within EXM and within  Bristol Myers Squibb (BMS)

Process Ownership

• The Quality Systems Senior Manager will act as end-to-end Process Owner of one or more Quality Systems used within Global External Manufacturing.
• The Quality Systems Senior Manager will also be accountable for overseeing the work of Process Owners within their teams.
• Own all elements of the process including relevant procedures/ forms, training materials, share point 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 BMS policies/directives 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 or directive changes, responsible for coordination of input from key stakeholders into the impact assessment to the process
• Regularly review the process (trends metrics, trends observations, right first time (RFT), Design, waste elimination) 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 ExM Tier 3 Quality Councils
• 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