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Regional Regulatory Quality and Compliance Associate Director Zaventem Belgium,
Posted on : 20 May 2017
- 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.
- 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.
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)
- 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
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