Manager, Regulatory Compliance/ Operations
Company: Bristol Myers Squibb
Location: New Brunswick
Posted on: November 24, 2022
At Bristol Myers Squibb, we are inspired by a single vision -
transforming patients' 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 has been in operation in Ireland since 1964,
employing over 650 people across a range of activities and business
Ireland is home to External manufacturing's global headquarters,
the business unit responsible for the management of manufacturing
contract operations (CMO's) and ensuring reliable supply of product
to patients 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 Headquarters
based in Dublin 15 and a distribution centre in Shannon, Co
For more information about Bristol Myers Squibb, visit us at
BMS External Manufacturing is looking to recruit a permanent
Manager, Regulatory Compliance/Operations who will report directly
to the Associate Director, Regulatory Compliance and will be
responsible for all regulatory support activities within External
Key Duties and Responsibilities:
Working as part of a team dealing with global market registrations
and providing regulatory compliance/operations guidance, and
support to all External Manufacturing groups.
Coordination of EXM quality dossier (Module 2 and 3) review process
for Pharmaceutical and Biologics products at all nodes of the
supply chain for new product introductions, and post approval
variations including but not limited to new manufacturing
facilities and process changes.
Point of Contact for requests to source and provide relevant
regulatory documentation (e.g. SOPs, Technical Reports, CoA's,
Analytical raw data) to support regulatory requests for post
approval variations, renewals, and annual reports.
Support product release by managing appropriate systems to ensure
product market compliance to enable seamless release of finished
product to the market.
Review of local and global change controls, deviations, CAPA's,
technology transfer plans, and regulatory submission plans.
Maintains strong communication and working relationships with all
departments, contract manufacturing organisations, and global
personnel such as CMC.
Participating in other QA supporting activities as required (e.g.
internal audits, site regulatory inspections, APQR's, quality risk
Qualifications, -Knowledge and Skills Required:
The successful candidate will have a minimum of 3 years
Quality/Compliance/Technical experience in a biopharmaceutical
Regulatory experience and familiarity with regulatory dossier
sections (Module 2 and 3) would be advantageous.
The candidate should be able to demonstrate:
Ability to work independently and within team matrix
Ability to manage teams associated with individual aspects of
responsibilities, direct people management and project management
Thorough knowledge of worldwide regulatory Good Manufacturing
Practices (GMP) requirements and a working knowledge of Food and
Drug Administration (FDA) & European Union (EU) GMP
In depth knowledge of Quality Management Systems with an emphasis
on change control principles and the applicability of
restriction/regulatory holds in the release process for changes
that require health authority approval.
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
Urgency : We move together with speed and quality because patients
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
You'll get a competitive salary and a great benefits package
including an annual bonus, pension contribution, family medical
allowance, 23.5 days annual leave plus 3 Company days, -life
assurance, on-site gym 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.
Keywords: Bristol Myers Squibb, New Brunswick , Manager, Regulatory Compliance/ Operations, Executive , New Brunswick, New Jersey
Didn't find what you're looking for? Search again!