Manager, Quality Assurance - Toxicology

Posted 27 Sep 2019

Rockville, Maryland - United States

Req Id 198048

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 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. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


Your Role:

The QA Manager leads the quality assurance unit directly responsible for the GLP and ISO 17025 program in Toxicology. The QA Manager ensures the GLP auditing program is defined and executed according to the regulations and all applicable SOPs. Provides interpretation and guidance for all regulatory matters to the auditing staff, operations, study directors and Test Facility Management.

 

  • Excellent background and understanding of GLP compliance and familiarity with all aspects of FDA, EPA and other applicable international regulations.
  • Assess the quality function on an ongoing basis to assure independence is maintained and regulations are met.
  • Assure adequate personnel are trained and have sufficient resources to perform their duties.
  • Maintain the QA budget within scope.
  • Host client and regulatory inspections and assure responses are accurately and efficiently delivered.
  • Identify regulatory compliance issues and provide regulatory support to the organization. 
  • Monitor performance of all staff and provide education and training to all staff based on individual needs.
  • Assist in the administration of a comprehensive GLP training program.
  • Ensure QA representation on appropriate functional teams.
  • Maintain good working relationships and communication with clients.
  • Assure the facility audit and vendor/subcontractor audit programs are functioning as intended.
  • Analyze and report trends in audit findings or other quality metrics on a periodic basis.
  • Identify process improvement opportunities and provide ideas to challenge the status quo while improving quality.
  • Lead or manage various project teams as required.
  • Provide supporting oversight to the archives, quality engineer and other site wide quality functions.
  • An understanding of laboratory quality assurance principles to ISO/IEC 17025:2005 and their application as specified in the Quality Manual
  • Ensure the Quality Management System is implemented, followed, and accreditation maintained 

 

Who You Are:

Minimum Qualifications:

  • Bachelor’s Degree.
  • 5+ years’ experience supervising an auditing or operational group is required.
  • 5+ years’ experience auditing in a GLP environment is required. 
  • Detail oriented with proven organizational and leadership skills.
  • Proficient in word processing, spreadsheets, and database software application.

 

Preferred Qualifications:

  • RQAP-GLP accreditation highly recommended.
  • Sound diplomatic, analytical and communication skills, both verbal and written.

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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