Quality Management Lead, Global Research & Development Quality (RDQ)

Posted 06 Mar 2020

Billerica, Massachusetts - United States

Req Id 204295


A career with EMD Serono is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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.

Your role:

Quality Management Lead drives quality and continuous improvement into the business and supports quality oversight of the R&D Quality Management System. In your role, you will be the business process owner for the end to end issue management framework establishing and governing the cross-functional and effective management of issues. You will also act as Root Cause Investigator and a CAPA champion advising the business functions in R&D with regards to Root Cause Analysis, CAPA quality and compliance. Furthermore you will use data driven approaches for issue management to ensure input into risk management, process management and knowledge management. The Quality Management Lead will also act as a change agent for the eQMS.


Who you are:

  • University degree in scientific or quality related subjects. Equivalent relevant professional experience may be considered.
  • Demonstrated working experience in international pharmaceutical and/or biotech industry, in particular clinical quality management, clinical development, regulatory compliance
  • Basic knowledge of other GxPs like GLP, GMP or GVP
  • Broad knowledge/expertise in continuous improvement with background in appropriate tools, methodologies and concepts: e.g. Quality Culture, Systems used for issue management including Root Cause Analysis (RCA) and CAPA management,  RCA methodologies and techniques, data driven approaches supporting issue management.
  • Solid working knowledge/expertise of principles and concepts of risk and issue management

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.


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