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Director, Clinical Portfolio Quality Management

Posted 16 Oct 2017

Billerica, Massachusetts - United States

Req Id 162767


A career with EMD Serono is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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.

Who We Are

EMD Serono is the North American biopharma brand of Merck KGaA, Darmstadt, Germany - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the brand has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas.

Your Role

You will be responsible to work closely with clinical study teams across the assigned portfolio to lead a systematic process for risk-based GCP quality management. This end-to-end process will involve quality planning, ensuring that risks to patient safety and data reliability are proactively identified, objectively assessed, and effectively mitigated. You will also be responsible for quality control by ensuring that relevant quality measures and risk thresholds are properly defined and that consistent oversight is performed. In addition, you will be responsible to lead quality improvement where quality deviations and issues surface. In this case you will partner with the respective study team(s) and other quality experts to investigate the root cause of the deviations/issues and to define, document and implement appropriate corrective and preventive actions. You will evaluate audit and inspection findings across the clinical trial portfolio seeking to identify and evaluate persistent and important quality issues and lead knowledge management and lessons learned exercises in order to prevent recurrence. You will manage the process to ensure ongoing inspection readiness for the portfolio by ensuring that the TMF is appropriately maintained, that IR tools are consistently utilized, and that quality issues are systematically remediated and/or escalated in a timely fashion.


 Who You Are

  • BS Degree with 10 years of experience, MS degree with 5 years of experience or PhD with 3 years of experience
  • Demonstrated expertise in clinical trial quality and working knowledge of Good Clinical Practices
  • Fluency in English (German an advantage)
  • Experience in pharmaceutical R&D with at least 3 -5 years direct experience of leadership in a GCP quality related discipline
  • Demonstrated experience in cross-functional team leadership
  • Extensive cross-functional knowledge of the Drug Development Processes and project 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!


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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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.


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