Location: Concord, OH
Our client is a leader in the development of small molecule pharmaceuticals. They pride themselves on high quality outcomes, outstanding customer service and looking after their employees.
— MISSION —
Reporting to the General Manager, the QA Manager will provide Quality oversight and support to the Technical Operations group for the manufacture and characterization of non-clinical, clinical and commercial products in compliance with GMP and GLP guidelines.
They will be accountable for establishing and driving Quality initiatives, maintaining and improving quality infrastructure and contributing to various CMC related project teams.
— KEY RESPONSIBILITIES —
• Responsible for the review and approval of quality documentation including quality agreements, project protocols, validation plans, batch records and associated analytical data related to the manufacture and characterisation of drug substances and drug products.
• Responsible for the reporting of drug substances and drug products.
• Perform in-study and in-process audits to assure compliance of operational activities.
• Administer Quality Management System databases for change control, deviations, and CAPAs.
• Management of a 3 to 5 person QA staff.
• Establish and administer corporate training program.
• Manage inspections by Regulatory Authorities.
— REQUIREMENTS —
• BS or equivalent in a technical discipline.
• 7+ years of experience in the pharmaceutical/ biotech industry.
• A minimum of five years of experience in Quality Assurance supporting manufacturing and characterisation of small molecule drug substances for clinical and commercial use in a contract environment.
• Working knowledge and technical understanding of the manufacture and testing of small molecule drug substances and drug products.
• Knowledge of GMP and GLP principles with respect to FDA and EMA regulations and guidelines.
• Knowledge of the drug development process.
• Experience in deviation investigations, root cause analysis, risk assessment and developing corrective action plans.
• Experience in data integrity / 21CFR Part 11 Compliance.
• Experience with process validation, analytical method validation and equipment qualification.
• Excellent communication and documentation skills.
• Experience managing multiple priorities and QA staff.
Please submit your application via the following email address: email@example.com quoting the job title in the subject.