Director of Quality Assurance
About Our Client
veterinary pharmaceuticals and animal health products manufacturer, whose products are sold worldwide. Focus on preventing disease and parasite infestation in livestock, poultry, equine and companion animals.
- Ensures all products manufactured in the facility and released to market are pure, safe, and effective and meet all established regulatory requirements.
- Keeps current with new guidelines and FDA inspectional and scientific trends and adjust facility procedures appropriately.
- Provides leadership developing and directing quality assurance and improvement initiatives for all company procedures or processes within the site and ensures ongoing compliance with local, national, and international standards and legislation.
- Ensures the entire facility operates in conformance with all regulatory requirements. Monitors the facilities compliance on a regular basis and addresses any deficiencies identified.
- Promotes and advocates quality achievement and performance improvement across the organization by integrating quality control tools into processes and supporting new product development.
- Lead the site transfer process for CMO projects including execution of gap assessment, coordination of technical transfer activities, QA oversight of manufacturing activities and development of Quality Agreements. Primary liaison with customer for quality and manufacturing issues.
- Oversee the Quality of R&D reports and activities for new product submissions.
The Successful Applicant
Ten years' relevant experience in a regulated Pharmaceutical industry including Quality Assurance and/or Quality Control, with 5 years in a leadership role
BS degree in science or related field
Knowledge of Analytical Chemistry, cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, manufacturing and packaging processes
Must possess leadership qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally
What's on Offer
Room for growth, with a great competitive salary and benefits package.