Senior Quality Specialist, Quality Excellence

Posted 07 Aug 2020

Rockville, Maryland - United States

Req Id 208884

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 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 Performance Materials is a business of Merck KGaA, Darmstadt, Germany.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.


Your Role:

 

As a Senior Quality Specialist in the Quality Excellence function, you will be responsible for activities that drive global Quality improvement. These will include activities such as driving inspection readiness, global simplification and standardization projects, authoring, reviewing and approving controlled documents to comply with appropriate regulations. Reporting to the Head of Quality Excellence, you will also play a key role in influencing and collaborating with stakeholders across multiple geographies, ensuring alignment and participation in these activities to deliver robust global implementation plans.

 

In addition to routine quality activities in a GXP environment, and as part of the Quality Excellence team, you will also:

  • Provide global support for regulatory inspections (including pre/post activities)
  • Drive standardization practices across the organization and champion procedure/process simplification
  • Conduct laboratory inspections to include inspection readiness, commissioning and/or internal audits
  • Champion the use and implementation of electronic records & other digital solutions
  • Provide quality direction and support for initiatives driven by Quality Excellence
  • Ability to travel (up to 20%) to other PSS sites located in US, EU and APAC

 

Who You Are:

Minimum Qualifications:

  • Bachelor’s degree in a scientific or technical discipline (i.e. Biology, Biotechnology, Chemical Engineering, etc.)
  • 4+ years’ experience working in a cGMP Quality role

 

Preferred Qualifications:

  • Track record of quality improvement and execution
  • Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity etc.)
  • Previous experience of participating in, and knowledge of, global agency inspection programs for the biopharmaceutical or biotechnology industry such as US FDA, EMA, TGA, MHRA etc.
  • Previous experience of driving/leading projects in a global environment
  • Demonstrated proficiency in communication, written/verbal and interpersonal skills
  • Advanced degree (i.e. Master’s degree) in a scientific or technical discipline (i.e. Biology, Biotechnology, Chemical Engineering, etc.)
  • Knowledge of Project Management tools and track record of successful project implementation

 

RSRMS


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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