Regional Regulatory Quality and Compliance Associate Director - Belgium
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- 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