A career with EMD Serono is an ongoing journey of discovery: our
58,000 people are shaping how the world lives, works and plays
through next generation advancements in Healthcare, Life Science
and Electronics. For more than 350 years and across the world we
have passionately pursued our curiosity to find novel and vibrant
ways of enhancing the lives of others. EMD Serono is a business of
Merck KGaA, Darmstadt, Germany.
United As One for Patients, our purpose in Healthcare is to help
create, improve and prolong lives. We develop medicines,
intelligent devices and innovative technologies in therapeutic
areas such as Oncology, Neurology and Fertility. Our teams work
together across 6 continents with passion and relentless curiosity
in order to help patients at every stage of life. Joining our
Healthcare team is becoming part of a diverse, inclusive and
flexible working culture, presenting great opportunities for
personal development and career advancement across the globe.
This role has the opportunity to work in a hybrid of both onsite
in Billerica/Rockland and remote. Onsite presence will be required
at short notice to host inspections at both locations.
Your role: An exciting new opportunity has arisen to join the
company's Global Inspection Management team as Inspection
Management Lead. We are looking for a highly motivated individual
with the ability to coordinate cross-functional and multicultural
global teams. In this role you coordinate the preparation,
execution and close out of GCP/GLP/GVP Regulatory Authority
Inspections of EMD Serono R&D projects or facilities.
Responsibilities include the coordination of inspection setup
activities and preparation of responses to inspection observations.
You will also host or participate in inspections as a member of the
You will also work on projects to continuously improve the
inspection management processes and educate internal and external
business partners on inspection management processes.
Who you are:
- Minimum 8 years QA experience or other relevant experience with
a minimum of 5 years in Clinical QA.
- Bachelors Degree with a focus on scientific subjects
- Sound experience with Regulatory Authorities inspections by
major authorities (MHRA, FDA, EMA, PMDA)
- In depth knowledge of drug development processes and respective
- Broad knowledge of relevant GxP areas (GCP, GLP, GVP)
- Good communication and problem- solving capabilities.
- Demonstrated ability to work independently and manage time
- Travel globally up to 20%
- Advanced Degree Preferred
What we offer: With us, there are always opportunities to break
new ground. We empower you to fulfil your ambitions, and our
diverse businesses offer various career moves to seek new horizons.
We trust you with responsibility early on and support you to draw
your own career map that is responsive to your aspirations and
priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No
employee or applicant for employment will be discriminated against
on the basis of race, color, religion, age, sex, sexual
orientation, national origin, ancestry, disability, military or
veteran status, genetic information, gender identity, transgender
status, marital status, or any other classification protected by
applicable federal, state, or local law. This policy of Equal
Employment Opportunity applies to all policies and programs
relating to recruitment and hiring, promotion, compensation,
benefits, discipline, termination, and all other terms and
conditions of employment. Any applicant or employee who believes
they have been discriminated against by the Company or anyone
acting on behalf of the Company must report any concerns to their
Human Resources Business Partner, Legal, or Compliance immediately.
The Company will not retaliate against any individual because they
made a good faith report of discrimination.