An essential role for providing quality oversight and support to the Technical Operations group for the manufacturing and characterization of non-clinical, clinical and commercial products in compliance with GMP and GLP guidelines.
- Excellent Compensation
- Reports to General Manager
- Location – Cleveland OH area
- Pharma industry
- International Work Environment
Our client, headquartered in the Cleveland OH area for their U.S. operations, is a privately owned European company with great international success! The company is a leader in the Active Pharmaceutical Ingredients (APIs) production, using synthetic and biological processes for Generic market as well as in Contract Development and Manufacturing (CDMO). The vision of the company is to excel in supporting their customers and understanding even their complex needs. Moreover, the company’s goal is to create a dynamic and harmonious work environment since projects may start in one location and could require collaboration from multiple branches.
In this crucial role you will have the unique chance to positively impact our client’s growth in the US market by providing Quality oversight and support to the Technical Operations group for the manufacturing and characterization of non-clinical, clinical and commercial products in compliance with GMP and GLP guidelines. The QA Sr. Manager will establish and drive Quality initiatives, maintaining/improving quality infrastructure and participating where needed on various CMC related project teams. The QA Sr. Manager will also be accountable for assuring compliance with the company’s Quality System, identifying/driving quality system improvement, quality oversight at the project level and generation of metrics to drive continuous improvement. Other main tasks will include, but not limited to the following:
- 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.
- Review and approval of deviations and resulting investigation reports, corrective actions and/or preventive actions for adequacy and logic of root cause analysis, and impact to both quality and regulatory commitments.
- Perform in-study and in-process audits to assure compliance of operational activities.
- Responsible for supplier and material qualification supporting GMP manufacturing.
- Establish and administer program to assure data integrity.
- Administer Quality Management System databases for change control, deviations, and CAPAs.
- Management of a 3 to 5 person QA staff.
- Responsible for corporate archives and document control.
- Establish and administer corporate training program.
- Manage inspections by Regulatory Authorities.
- BS or equivalent in a technical discipline and a minimum of 7-10 years of experience of in the pharmaceutical/biotech industry.
- Must have at least 5 years of experience in Quality Assurance supporting manufacturing and characterization of small molecule drug substance for clinical and commercial use in a contract environment.
- Working knowledge and technical understanding of the manufacturing 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 is process validation, analytical method validation and equipment qualification.
- International experience is a big plus.
- Live or willing to relocate in the Cleveland OH area.
- No visa sponsorship is available for this position as well as relocation from outside the US.