Quality Assurance Manager

ABOUT THE COMPANY

Mackenzie Stuart is working in collaboration with a well-established, global pharmaceutical manufacturing company.

This is a fantastic opportunity for an experienced Quality Assurance Manager to contribute to the ongoing success of a multi-billion-dollar turnover business. If you’re looking for a company that offers a challenge but also fosters a collaborative culture – this could be opportunity for you!

ABOUT THE ROLE

The QA Manager will be responsible for the management of all aspects of quality assurance (as detailed below), as well as supervising a team of QA specialists.

Key responsibilities:

• Act as the primary QA point of contact for customers; ensuring regular communication, sustaining relationships and resolving complaints
• Ensure compliance with all cGMP and other relevant regulations across manufacturing and quality control operations; ensure continuous improvement and readiness for regulatory agency inspections
• Oversee site readiness for regulatory agency inspections
• Provide targeted training to QA staff in areas such as cGMP regulations and performing internal audits
• Lead, coach and develop team members by setting goals, monitoring performance and delivering feedback
• Review and approve change control processes, Master Production records, investigation reports, CAPAs and audit responses
• Develop and maintain Customer Quality agreements, ensuring QA requirements are met and timelines/systems are aligned with customer expectations

ABOUT THE PERSON

Required:

• Minimum Bachelor’s degree in a STEM discipline such as chemistry, chemical engineering or another related field
• 5+ years’ relevant experience in a QA role for a pharmaceutical company,
• Strong working knowledge of FDA regulations and cGMP requirements for pharmaceutical manufacturing
• 3+ years proven leadership experience, ideally in a QA role
• Experience in most aspects of drug development
• Demonstrable project management experience; ability to manage priorities and deadlines, handle fluctuating workloads and deliver high-quality outcomes
• Excellent written and verbal communication skills, with the ability to communicate complex technical information to non-technical audiences
• Proven ability to resolve problems or conflicts, and ensure compliance within a fast-paced environment

Please submit your CV if you have the requisite skills outlined above and are looking for a new opportunity in the pharmaceutical manufacturing industry. Unfortunately, due to the high volume of expected responses we are only able to acknowledge successful applications. If you have not been contacted within 2 weeks, on this occasion your application has been unsuccessful.

About Mackenzie Stuart Global Executive Search & Selection

Mackenzie Stuart is a leading executive search and selection business. From our offices in Leeds, we provide retained and contingency recruitment solutions across industry and have specialist recruitment consultants that work within the Oil & Gas, Mining, Construction, Medical, Finance, Insurance, FMCG and Manufacturing sectors.