Senior Manager, Qa Qualified Person

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, 2021 and 2022.

The Role

The primary role will be supporting in the implementation, organizing, managing, and execution of the Quality Assurance function and Quality Management System of Celgene Distribution BV which will ensure product quality and compliance of relevant manufacturing and distribution activities with all regulatory and corporate requirements for BMS Products within EU/EEA and Rest of World Markets as applicable. This position also acts as a Qualified Person as per requirements of Celgene Distribution BV license(s). Executes Qualified Person duties and responsibilities in accordance with Article 51 of Directive 2001/83/EC and Professional Code of Conduct. The Qualified Person is invested with the authority to make decisions with regards to product quality, safety, purity, and efficacy independent of other business interests. Products are for commercial and named patient supply use only.

Responsibilities
As required, act as Qualified Person as per requirements of Celgene Distribution BV and Cruiserath Ireland licenses and execute functions in accordance with Professional Code of Conduct.
Certification of batches of finished product to be released to the EU/EEA and ROW markets which have been manufactured and checked in accordance with its marketing authorization, the principles and guidelines of GMP as laid down in Directive 2003/94/EC and other relevant legal requirements.
Familiarization with the individual product regulatory dossiers.
Coordination of the QA team to support batch certification activities.
Oversight of compliance and quality activities including Quality Risk Management, internal and supplier auditing, inspection management, records management, and change control.
Collaboration with QC and other functional areas to support new product introductions.
Approval of change controls, significant deviations, customer complaints and annual product quality reviews as required.
Ensure quality agreements are in place to support the batch certification process.
Act as an SME in regulatory and corporate audits.
Participation in the site self-inspection program by conducting audits of site functions.
Participate in GMP- or GDP-related health authority inspections or internal corporate audits at Celgene Distribution BV.
Participation in the product recall process and BOH notification process.
Undergo continuous professional development including self study, site visits, internal and external training courses and participation in corporate and regulatory inspections.
Ensure access to the audits reports of sites involved in the manufacture and the testing of medicinal products being certified.
Interact with executive level employees at third party contractors.
Interact with Corporate and International functions as required by the tasks andresponsibilities.

Qualification, Knowledge and Skills

MSc (or equivalent) in a technical or scientific discipline which and meets the EU Qualified Person educational requirements as described in Article 49 2001/83/EC in addition to any national requirements.
Eligible to act as Qualified Person within EC/EEA.
Extensive pharmaceutical quality assurance/control experience (equivalent to a minimum of 5 years experience), including audit, batch record review, change control, complaint handling and investigations experience.
Must have experience and good knowledge of a variety of dosage forms ideally including solids, sterile and biological products.
Must have proven strategic thinking and contingency planning skills.
Must have excellent communication skills, including excellent written, interpersonal, collaboration, negotiation and dispute resolution skills, with a team oriented approach.
Effective planning skills and recruitment skills to identify strong performers, hire adequate members of staff and establish a high performance organization; ability to anticipate resource needs and help establish priorities.
Strategic thinker who can balance near term objectives with long term goals and outcomes, evaluate risk and develop effective solutions through an integrated multi-disciplined decision-making approach.
Must have excellent organizational, project management and problem solving skills.
Must have thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements (US and EU, particularly).
Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance.
Must have computer proficiency.
Must have superior attention to detail.

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 an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym.

#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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