Senior Manager, QA Compliance

Senior Manager, QA Compliance (Materials Management) page is loaded Senior Manager, QA Compliance (Materials Management) Apply locations Cruiserath - IE time type Full time posted on Posted Yesterday job requisition id R1578115

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 has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021.

For more information about Bristol Myers Squibb, visit us at BMS.com/ie

The Role

The QA Compliance Materials Management Senior Manager will be responsible for leading the material qualification program for both the drug substance and drug product facilities and leading the site's Quality Risk Management (QRM) program here in Cruiserath Biologics. The Senior Manager will also be responsible for managing a team and ensuring compliance with regulatory requirements.

Due to the nature of the role, the Senior Manager, QA Compliance (Materials Management) may work in other and/or multiple QA areas once the appropriate training has been completed. Their responsibilities may include some or all as outlined below.

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:

• Act as the Local Process owner for the Material qualification program on site and represent Cruiserath within the global L2 group function.
• Develop and implement policies and procedures for material qualification, ensure compliance with regulatory requirements, and manage the overall process of material qualification for both the drug substance and drug product facilities.
• Develop, maintain, and manage the material certification requirements and Direct Dispense program for drug substance and drug product facilities.
• Lead a team who will manage the release for use all raw materials, working cell bank and where applicable consumables for use in the plant.
• Act as the Site Quality Risk Management (QRM) Lead. The QRM lead is responsible for leading the QRM program across the site, which includes identifying, assessing, and managing risks associated with the organization's products, processes, and systems.
• The QRM lead is responsible for collaborating with other departments to ensure that QRM activities are integrated into the organization's quality management system.
• People Management: Manage a team, set performance goals, provide coaching and feedback, conduct performance evaluations, and manage employee development and training.
• Compliance Oversight: Ensure that all activities related to material qualification and QRM are conducted in compliance with applicable regulations and guidelines. Monitor compliance, identify areas of non-compliance, and develop and implement corrective actions as needed.
• Support the SDP facility through start up to pre-approval inspection (PAI) readiness and into commercial biologics drug product manufacture.
• Support QA Compliance team inspection readiness team for self-inspection, Health Authority, corporate or customer inspections.
• Cross-Functional Collaboration: Work closely with other departments, including Manufacturing, Quality Control, and Supply Chain, to ensure that material qualification and QRM activities are integrated into the overall quality management system.
• Continuous Improvement: Identify opportunities for continuous improvement in the material qualification and QRM programs. Analyze data, identify trends, and develop and implement process improvements.

Qualifications, Knowledge and Skills Required:

• Educated to a degree level in science or related discipline with a minimum of 7-10 years quality experience in the Biopharmaceutical/Pharmaceutical industry.
• Thorough understanding of cGMP requirements, as applicable, for:
• Quality systems and compliance
• Laboratory compliance including equipment and instrumentation qualification requirements.
• Manufacturing Operations
• Technical Operations including technical transfer, qualification, and validation requirements.

• Core competencies include leadership, communication skills, teamwork, problem-solving, decision-making, flexibility to react to changing business needs, ability to meet deadlines and a commitment to compliance and continuous improvement.
• Work on his/her own initiative in addition to working as part of a team.
• Work across a team matrix in order to meet accelerated timelines.

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

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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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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.

W e’re creatinginnovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.