Cruiserath, IE
12 hours ago
Manager, QA Documentation Management Lead

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

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

BMS Cruiserath Biologics is seeking to recruit a Manager, QA Systems – QA Documentation Management Lead for a 12-month fixed-term contract. Reporting to the Senior Manager, QA Systems, the QA Documentation Management Lead will join the QA Systems Team and have direct responsibility for the QA Systems Document Control group. This individual will be responsible for managing the documentation systems at the Cruiserath site.

Key Duties and Responsibilities:

Develop and maintain documentation systems on site including the electronic document management system, the archival program, and the issuance of controlled documents.Support the site implementation of new electronic systems relating to document management.Provide cross-departmental support for a variety of document management systems and processes.Participate as an SME in self-inspection, Health Authority, Corporate or Customer inspections.Support audit readiness activities and act as a key member of the audit support team during inspections.Hire, train and develop QA Systems Specialists and ensure personnel have adequate training, education and experience to perform their GMP-related job function effectively.Develop direct reports through coaching, mentoring and training.Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.Represent QA as a team member or project lead in operational excellence and cross-functional process improvement teams.Support the authoring, review and approval of site procedures.Support the completion of investigation/CAPA activities as required.Support the implementation of applicable global systems.Support the implementation or management of additional QA Systems as required.  

Qualifications, Knowledge and Skills Required:

The successful candidate will hold a BSc in science, engineering or a related discipline, along with 4+ years’ Quality experience in a biopharmaceutical environment.Thorough understanding of cGMP requirements for Quality Systems and Compliance.Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.Ability to contribute to a team-based, collaborative environment promoting clarity of purpose and high commitment to business goals.Ability to prioritise objectives for multiple projects, adhere to schedule timelines while maintaining flexibility and attention to detail.Ability to participate in large and complex projects, develop schedules and provide effective communications to customer and stakeholders.Ability to network globally with the BMS network and stay current with latest initiatives.Good troubleshooting skills and a flexible approach to objective management.Experience in regulatory inspections.

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.

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/

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

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