Job Details: Quality Operations Senior Specialist Drug Product


JobsIreland
Jervis Street
Dublin 1
Quality Operations Senior Specialist Drug Product


At Bristol Myers Squibb, we are inspired by a single vision -
transforming patients&#**Apply on the website**; lives through
science.In oncology, hematology, immunology and cardiovascular disease
- and one of the most diverse and promising pipelines in the industry
- each of our passionate colleagues contribute to innovations that
drive meaningful change. We bring a human touch to every treatment we
pioneer. Join us and make a difference.

-

BRISTOL MYERS SQUIBB IRELAND

Bristol Myers Squibb (BMS) has been in operation in Ireland since
**Apply on the website**, employing over **Apply on the website**
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
**Apply on the website** 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&#**Apply on the website**;s growing
biologics portfolio and plays a central role in Bristol Myers Squibb
global manufacturing network.

ExM&#**Apply on the website**;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&#**APPLY ON THE WEBSITE**;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 &#**Apply on the website**;
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 &#**Apply on the website**; ll get a competitive salary and a
great benefits package including, but not only, an annual bonus,
pension contribution, family health insurance, **Apply on the
website**.5 days annual leave plus 3 Company days, access to BMS
Cruiserath on-site gym, life assurance and gain-sharing bonus.

Around the world, we are passionate about making an impact on the
lives of patients with serious diseases. Empowered to apply our
individual talents and diverse perspectives in an inclusive culture,
our shared values of passion, innovation, urgency, accountability,
inclusion and integrity bring out the highest potential of each of our
colleagues.

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.



We need : English (Good)

Type: Permanent
Payment:
Category: Others

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