Σχετικά με την εργασία
We are seeking a Director of Quality to join our North American headquarters in St. Paul, Minnesota.
As a Director of Quality, you will:
- Manage quality team and oversee all QA and QC aspects with the aim of contributing to the organization’s strategy.
- Directly supervise all compounding and aseptic personnel.
- Determine the policy lines in the framework of the entire quality process, while ensuring they are compliant.
- Translate strategy into quality in actual projects utilizing generally accepted quality standards (including ISO standards, corporate TQM, GMP, GDP, etc.) to achieve continuous improvement.
- Guarantee quality within the complete flow from raw material to product and continuously strive to achieve optimum quality.
- Assure adequate control and documentation of controlled substances, per state and DEA regulations.
- Follow all federal, state and local laws, rules and regulations for quality and safety in the preparation of pharmaceutical products.
- Interact regularly with federal and state agencies (FDA and DEA primarily) and serve as the contact for suppliers, customers and local authorities on the subject of quality.
- Analyze issues and initiate and follow up on improvement projects to achieve and improve quality standards.
- Carry out the final review of all the validation protocols, assuring quality is in line with regulations
- Analyze and report on the results of quality controls, and prepare, manage and follow up on audits.
- Site responsibility to address all orders related to business working with legal.
Ξεχωρίστε από το πλήθος
You possess the following qualifications, background and abilities:
- Pharmacy degree and license preferred, but not required
- Experience working within GMP standards is required.
- 10+ years of experience in a quality department, ideally working on an international scale
- 2 years related experience in compounding or pharmaceutical processing is preferred
- CAPA and/or root cause analysis experience is ideal
- Experience working and coordinating with analytical testing labs
- Team leadership or management experience is required
- Technical ability, analytical ability, and decisive judgment
- Self-motivated with a strong work ethic
Τι προσφέρεται;
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.