Quality Operations Senior Specialist Drug Product

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.



Bristol Myers Squibb Ireland

Bristol Myers Squibb (BMS) has been in operation in Ireland since 1964, employing over 600 people across a range of activities and business units.

The Global External Manufacturing (ExM) organization headquartered in Dublin, is responsible for the management of manufacturing and reliable supply 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 HQ in Dublin 15 and a distribution centre in Shannon, Co Clare.

Many of the global business services, including Commercial, the European Treasury Centre, Global Bio Lab and Global Logistics are based on the island of Ireland.Ireland is also home to Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility. This state of the art facility produces multiple therapies for the company's growing biologics portfolio and plays a central role in Bristol Myers Squibb global manufacturing network.

ExM's strategy and robust operating model is focused on evolving and continuously improving ways of working to take External Manufacturing to the next level, leveraging data and technology in an effort to deliver product to customers and patients at optimum speed, time and cost.

The Role

BMS External Manufacturing is looking to recruit a permanent Quality Operations Senior Specialist Drug Product to p rovide quality and compliance oversight support to the Quality Operations management team within External Manufacturing .

Key Duties and Responsibilities:


Support the coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships.
Actively support the BMS Fact Finding (FF) and Product Review Committee (PRC) processes for major investigations involving Third Party products.
Provide quality/compliance support to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MT teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs etc.
Provide the requisite quality support to Global BMS functional groups such as Global Regulatory/CMC and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions etc.
Coordinate quality metrics programs in relation to Third Party performance.
Provide support to Quality Operations Management Team in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties.
Assist in the preparation of Quality Agreements with the Third Party Manufacturers and Alliance Partners.
Review the Annual Product Reviews submitted by the Third Party Manufacturers.
Support the Global BMS external auditing program by participation in audits of Third Parties as requested.
Provide support to specified quality and technical projects as they arise.


Required Competencies , Qualifications and Desired Experience :


In depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets
Ability to develop cross-functional and external working relationships
Strong communication and presentation skills across all levels both internal and external to BMS.
Proven analytical and problem solving skills.
A BSc in a scientific discipline such as Chemistry or Microbiology
Minimum 5 years experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency
Experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
Ideally will have experience in interacting with Health Authorities and supporting Health Authority inspections
Direct experience in interfacing with external manufacturers


What's important to us

Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:


Passion : Our dedication to learning and excellence helps us to deliver exceptional results.
Innovation : We pursue disruptive and bold solutions for patients.
Urgency : We move together with speed and quality because patients are waiting.
Accountability : We all own BMS ' success and strive to be transparent and deliver on our commitments.
Integrity : We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
Inclusion : We embrace diversity and foster an environment where we can all work together at our full potential.


We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.

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, 23.5 days annual leave plus 3 Company days, access to BMS Cruiserath on-site gym, life assurance and gain-sharing bonus.


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 the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1525568_EN

Updated: 2020-05-29 00:00:00.000 UTC

Location: Dublin,Ireland

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Sign Up Now - PharmaceuticalCrossing.com