Our client is a leader in the develop of small molecule pharmaceuticals. They pride themselves on high quality outcomes, outstanding customer service and looking after their employees.
— MISSION —
They are looking for a Quality Assurance (QA) Manager with in-depth experience in small molecule drug substance development and manufacturing and who prides themselves in compliance with GMP and GLP guidelines.
Reporting to the General Manager, the QA Manager will provide Quality oversight and support to the Technical Operations group for the manufacture and characterisation of non-clinical, clinical and commercial products in compliance with GMP and GLP guidelines.
The QA Manager will be accountable for establishing and driving Quality initiatives, maintaining/improving quality infrastructure and participating where needed on various CMC related project teams. You will be identifying and driving quality system improvement and generation of metrics to drive continuous improvement.
— 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 characterization of drug substances and drug products
- Responsible for the disposition 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
— MAIN REQUIREMENTS —
- BS or equivalent in a technical discipline
- 7+ years of experience in the pharmaceutical/ biotech industry
- Must have at least 5 years of experience in Quality Assurance supporting manufacturing and characterisation of small molecule drug substance for clinical and commercial use in a contract environment.
- Working knowledge and technical understanding of the manufacture and testing of small molecule drug substance and drug product
- Knowledge of GMP and GLP principles with respect to FDA and EMA regulations and guidelines
- Knowledge of 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 in process validation, analytical method validation and equipment qualification
- Excellent communication and documentation skills
- Experience managing multiple priorities and quality assurance staff
Please submit your application via the following email address: firstname.lastname@example.org quoting the job title in the subject.