Regulatory Compliance Manager

|Scientific & Pharmaceutical - Quality Assurance & Regulatory|New Zealand
  • Leading global organisation
  • Key regulatory position with growth opportunities
  • Auckland location

The Organisation:
Our client is a global leader in their field, employing hundreds of thousands of people across most of the countries in the world.  They are involved in many of the products we take for granted in our daily lives.  Their NZ head office is in Auckland, where this role is based, but they also have satellite sites across NZ.  They operate in a fast-paced environment while maintaining the highest of customer service standards.
 
The Vacancy:
We are currently seeking an experienced Compliance and Regulatory professional to lead all functions in this department for our client.  With the company having to transcend many different levels of regulatory compliance, from Medsafe through MPI/ACVM and downwards, our client needs someone with experience in at least some of these. 
 
Reporting to the National Quality Manager, key areas of focus for this role will include maintenance of validation programs, audit & compliance programs, and provisioning of training and culture change. You’ll be a key driver for QA & Regulatory and Validation projects, on-boarding of new clients/infrastructure/packaging, compliance assessments, leading Regulatory body relationships and programmes.
 
You, the candidate:
To be successful in this role you will preferably need to have a strong QA/compliance/regulatory background in pharmaceuticals, food or dairy manufacture, though experience in other industry sectors will be considered too.  A strong understanding of cGMP and broad quality systems will be a significant advantage.  You will also have proven motivational and team management experience and the ability to develop and maintain strong professional business relationships with colleagues, clients, suppliers and auditing authorities. You’ll ideally have some project SME or management experience too.
 
The successful candidate will ideally possess the following attributes:

  • A relevant tertiary qualification in Science/Technology/Engineering or similar
  • 3+ years experience at management level
  • 8+ years experience with compliance, regulatory and/or QA within a highly regulated operational environment
  • Proven strategic leadership experience, mentoring and developing your team
  • Highly developed communication and organisational skills
  • Ability to continually evaluate the quality systems and maintain complete documentation to ensure the necessary controls are in place
  • Internal and external auditing experience
  • Deliver results within tight deadlines, able to react promptly and decisively
  • Provide support and training to allocated staff on quality issues
  • Liaise with suppliers on quality issues

This is an excellent opportunity to lead and develop a team with this highly regarded employer. 
 
For a confidential enquiry or to apply for this position please click on the APPLY button or alternatively contact Tony De Barr on 04 916 0541 or email tony@trs.co.nz .
Note: If this vacancy is not exactly what you are seeking, then please contact me in confidence to discuss your individual requirements.