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Research Development Quality Inspection Management Lead

Company: Merck KGaA
Location: Billerica
Posted on: June 9, 2021

Job Description:

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 Inspection Team.

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 Qualifications:

  • 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 international regulations/guidelines
  • Broad knowledge of relevant GxP areas (GCP, GLP, GVP)
  • Good communication and problem- solving capabilities.
  • Demonstrated ability to work independently and manage time efficiently
  • Travel globally up to 20%

Preferred Qualifications:

  • 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

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.

Keywords: Merck KGaA, Billerica , Research Development Quality Inspection Management Lead, Other , Billerica, Massachusetts

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