Associate Director of Operations Compliance

A global innovator and leading bio pharmaceutical company that has been inventing new ground breaking treatments for numerous life threatening diseases for more than a century. Through this organisations prescription medicines, vaccines, biologic therapies, and animal health products, they work with customers and operate in more than 140 countries to deliver innovative health solutions. Recently a requirement has arisen to recruit an Associate Director Operational Compliance to be based at the organisations Biologics manufacturing plant in Cork. Seeking an increase of over 100 employees in the next 12 months, you will be part of an exciting growth journey for a well established site.

The Role:

  • This role is responsible for maintaining all aspects of compliance, supply, strategy and profit within the growing Biologics site, including GMP, EHS, Technical and Engineering
  • This role will provide an excellent understanding of all aspects of the business
  • To embed a culture of compliance and safety excellence within the Biologics team, and to work with compliance peers across the business to ensure best practice compliance is implemented
  • You will be responsible for overall CAPA effectiveness programme and continued improvement on root cause analysis and follow-up CAPA
  • You will be responsible for development and deployment of visual metrics within the Department
  • Accountable for all maintenance & adherence to standards owned within the department e.g. QMS, Engineering Standards, Validation Standards
  • You will be innovative in devising lean compliance systems that anticipate future department needs aligned with industry best practice, along with developing an over-arching CI program to further improve their high performance culture

The Person:

  • You will have at least 10 years experience within a Pharmaceutical/Bio-pharmaceutical/Medical Device (Class 3) working environment. Coming from a FDA/HPRA regulated environment will ensure success for the appointee as well as providing immediate credibility
  • Your experience will come from either Production/Technology/Engineering/Quality/Supply Chain (Manufacturing)
  • You will have direct experience in managing complex projects (CI) at both site and corporate level – your analytical and budgetary skills will be of great value here
  • Technical capability in EHS is desirable
  • Degree qualified in Supply Chain, Science or Engineering plus green belt or similar CI qualification

The Reward

  • This an organisation with excellent career progression and those who demonstrate excellence in the delivery of their role can be fast tracked
  • There is an excellent package on offer including Full Family Health care, Bonus, Defined Benefit Contribution with up to 33 Days Annual Leave

Contact Ashling Edwards at HRM on +353 214358748 for further details on this role in confidence or apply online.

Salary: €90000 - €90000 Location: Cork