Trius Therapeutics (NASDAQ: TSRX) is a biopharmaceutical company focused on the discovery, development and commercialization of novel antibiotics for the treatment of serious bacterial infections The company's lead asset, tedizolid phosphate, is a novel antibiotic that has completed Phase 3 registration trials and the company plans to submit an NDA in the 2nd half of 2013. Trius also has a preclinical gram negative program that is looking at novel targets.
The Director Quality Systems is responsible for planning and implementing the quality systems strategy to meet company objectives. This individual implements policies and procedures to ensure compliance with applicable US Federal and applicable worldwide regulations. Plans, coordinates, and directs quality systems to ensure products are consistent with established standards.
- Plans and directs resources and activities of the QA functions related to Complaints Management, Recalls, Quality Investigations, Document Control, labeling and Training.
- Designs and develops procedures and processes for recording, evaluating and reporting quality data.
- Ensures annual product review is conducted and documented.
- Manager GXP CAPA program and reviews for effectiveness.
- Prepares Quality metrics for senior management review.
- Responsible for developing periodic GXP compliance training.
- Participates in QA department budgeting.
- Leads the implementation of electronic quality management systems.
- Provides leadership during health authority inspections of quality management systems.
- Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance of quality management systems.
- Ensures that Quality System resources are appropriately staffed and trained to meet company objectives.
- Maintains up-to-date knowledge of FDA, EMA and WHO regulations as well as all policies and procedures, quality systems and FDA regulation and other regulatory requirements.
- Performs other duties assigned as needed.
Preferred Education and Experience:
- Bachelor’s degree in a scientific discipline.
- A minimum of 10 years experience as a Quality Professional in an FDA regulated industry required. 5 years of experience in a significant Quality Systems role within a commercial pharmaceutical company.
- Minimum of 5 years of prior supervisory experience required.
- In depth knowledge of quality and manufacturing systems and processes and applicable regulations is required.
- Practical knowledge of Quality Systems is required.
- Superior verbal and written communications skills and ability to effectively communicate with internal and external personnel at all levels of the organization.
- Working knowledge and experience managing contract manufacturers is required.
- Up to approximately 20% domestic and international travel may be required.
We attribute our success to our talented team of highly motivated individuals who show a passion and commitment to their work. We are proud to provide a workplace that is dynamic, collaborative, diverse, challenging and rewarding. Trius is committed to excellence and seeks qualified and highly motivated team players who want to make an impact. Our compensation and benefits packages are competitive.
Trius is proud to be an Equal Opportunity Employer with a commitment to Affirmative Action for Minorities, Women, Individuals with Disabilities, and Veterans.