Quality and Regulatory Manager

• New Medicinal Cannabis pharmaceutical sector
• Great opportunity to develop a quality system
• Flexible location

US:
Kāriki Pharma are one of the pioneers of the new medicinal cannabis sector in New Zealand. They are developing well-grounded roots from which to develop a range of successful products for domestic and global markets. With an R&D facility, a partnership with Australia’s first-to-market medicinal cannabis company and a certified cGMP contract manufacturer in place, they are now in an exceptional strategic position to push forward to meet the growing market.

THE ROLE
As part of this growth, Kāriki Pharma is seeking an experienced Quality and Regulatory Manager to join their team. This high-level position will be responsible for installing and then maintaining the regulatory and compliance framework for the company to supply their controlled products to the market. Reporting to the CEO, this position is strategically important to the business and the incumbent will be expected to provide insight and information to the Board and work collaboratively with the regulatory authorities, contract manufacturers and suppliers.

This is an excellent opportunity to get in on the ground floor in this new and exciting pharmaceutical industry sector. The location is flexible, provided you can work autonomously.

YOU:
You will need to have a solid base of quality and/or regulatory experience in the pharmaceutical industry at a senior level. You will ideally have developed a QA/RA framework for a pharmaceutical business or have long experience in maintaining such a system. A strong communicator, you will be able to build and maintain solid working relationships with those around you and also be able to work autonomously and independently according to the needs of the business. You’ll have outstanding time and project management skills and find solutions to roadblocks to ensure the company meets its obligations to customers.

As the successful candidate you will ideally possess the following attributes:

• A relevant tertiary qualification in Science/Technology or similar
• Significant experience at a QA/regulatory leadership level within a GMP environment
• Sound understanding and experience with internationally accepted quality/regulatory systems including EU-GMP, PIC/S, ISO 900X and European Pharmacopeia
• Previous experience in building and maintaining a robust quality system in line with international regulations
• 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 auditing experience
• Deliver results within tight deadlines
• Liaise with suppliers/customers on quality issues

For a confidential enquiry or to apply for this position please click on the APPLY button, 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.