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Regional Regulatory Quality and Compliance Associate Director - Belgium  

MSD (company)


Posted on : 20 May 2017

Project Description

Regional Regulatory Quality and Compliance Associate Director, Brussels and multiple locations-COM000506DescriptionMSD 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)- Brussels, Belgium.This role reports to the Director, Regional Regulatory Quality and Compliance and is primarily based in our Brussels, Belgian site, however, 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.QualificationsEducation Minimum Requirements: " Bachelor s Degree, or equivalent, in relevant health care areaRequired 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)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.Are you interested in contributing your know-how to a dynamic and innovative environment that allows you to show initiative and that offers long-term perspectives in an international environment?Then please apply online by: Friday 9th June 2017Recruitment Agency / Search Firm representatives please note:MSD will not accept unsolicited CVs from recruitment agencies / search firms under any circumstances. In order to present CVs to MSD, your Recruitment Agency / Search Firm will have been invited to work on a specific vacancy and have Terms of Business signed and agreed with the relevant Recruitment and Staffing Regional Lead. Should you send CVs for a vacancy that you have not been specifically invited to work on to any employee at MSD (via email, post, internet, Taleo or any other method), these will be deemed the sole property of MSD. MSD will pay no introduction fee to the Recruitment Agency / Search Firm if a candidate is hired as a result of an agency introduction under these circumstances.Job: Compliance And Ethics Job Title:Regional Regulatory Quality and Compliance Associate Director, Brussels and multiple locationsPrimary Location: EMEA-BelgiumEmployee Status: RegularTravel: Yes, 10 % of the TimeNumber of Openings: 1Company Trade Name:MSD Job Segment: Regulatory Affairs, Manager, Compliance, Law, CAPA, Legal, Management

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EMEA Belgium

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