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Regional Regulatory Quality and Compliance Associate Director Zaventem Belgium,  

MSD (company)


Posted on : 20 May 2017

Project Description

Description
  • Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.   
  • Today, we are building a new kind of healthcare company  one that is ready to help create a healthier future for all of us.
  • Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.  
  • To this end, we strive to create an environment of mutual respect, encouragement and teamwork.  
  • As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
  • We have an exciting opportunity for a Regional Regulatory Quality and Compliance Associate Director-Global Regulatory Affairs & Clinical Safety (GRACS)
  • This role reports to the Director, Regional Regulatory Quality and Compliance and there is flexibility for the person in this role to be based in other EMEA locations. 
  • The Regional Quality & Compliance Associate Director will be responsible for ensuring high quality & compliance within the Global Regulatory Affairs & Clinical Safety (GRACS) organization focusing on their region.



Role responsibilities:
  • Assist in the preparation and facilitation of Health Authority and Notifying Body inspections and audits.
  • Facilitate non-compliance investigations to initiate root-cause analysis in an effort to problem solve and drive process improvement.
  • For inspections, audits and investigations closely follow corrective and preventative actions (CAPA) to ensure their completion in a timely manner.
  • Collaborate with the Regional Quality & Compliance Lead, Regulatory Affairs Regional & Country Leads, Business Process Management and Process Owners to assist in the creation of quality management plans which outline metrics for key business processes.
  • Assist in risk assessment activities and risk mitigation plan development.
  • Collaborate on process improvement initiatives with Business Process Management and other process owner and stakeholders.
  • Collaborates with the Regulatory Quality & Compliance Lead and functional areas in monitoring key metrics within the region/country for trend analysis and development of corrective and preventative action plans.  
  • Communicating metric data and analysis for oversight by senior management on a quarterly basis.
  • Accountable to ensure that corrective and preventative action plans to inspection, audit and non-compliance reports have been executed and CAPA evidence is collected.
  • Supports the Regional Regulatory Quality & Compliance Lead with trending of current audits, inspection and investigation observations.


Qualifications
Bachelor s Degree,  or equivalent, in relevant health care area



Required Experience and Skills:
  • Minimum of 5-7 years of working experience within a Regulatory compliance or Pharmacovigilance, or Quality function.
  • Knowledge and understanding of regulatory & PV processes; as well as, quality management and control tools is required
  • Extensive experience in managing a culturally diverse organization
  • Ability to influence others across levels of the organization
  • Demonstrates a track record of accomplishments
  • Extensive experience in GCPs, GMPs or GLPs
  • Process Improvement Management, Root cause analysis/problem solution, excellent communication with relevant area
  • Possesses mastery of written and spoken English, beneficial to have mastery of another language(s)



Offer:
  • Our employees are the key to our company s success.  
  • We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.  
  • Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.


Travel: Yes, 10 % of the Time


Job Segment:  Regulatory Affairs, Manager, Compliance, Law, CAPA, Legal, Management                       

Locations

EMEA Belgium

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