Trius Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization off innovative antibiotics for serious life-threatening infections.
The Sr. Manager of Quality Assurance is responsible for execution of systems and processes to ensure compliance with GMP regulations. The position requires a seasoned Quality Assurance professional with experience in GMP drug substance and drug products with an in-depth knowledge of global regulatory and compliance requirements. The role is responsible for providing quality guidance and direct quality management oversight of global third party contact manufacturers.
Summary of Key Responsibilities:
- Provides cGMP guidance to internal departments and contractors for all phases of product development as applicable.
- Works directly with CMOs to ensure that clinical/commercial drug substance and drug products meet all required standards and specifications.
- Ensures effective QA support for manufacturing and disposition of clinical and commercial lots. Ensures compliance with quality systems such as change control, quality investigations, CAPA resolutions and Quality Agreements.
- Manage auditing of CMOs, and participate in internal audit program. Evaluate adequacy and effectiveness of corrective action plans.
- Maintains required knowledge of applicable regulations and government, industry and company GMP standards and their interpretations by participating in industry trainings, workshops and discussion groups. Serves as internal consultant in interpretations of regulations, standards and compliance issues, with minimal supervision.
- Key strategic member of Quality Assurance, providing guidance and direction for quality initiatives.
- Participates in development of corporate written policies and procedures.
Required Skills, Knowledge, Abilities and Experience:
- BA/BS degree in life sciences and minimum 10 years relevant industry experience in a GMP Quality (QA/QC) environment.
- Experience managing CMO’s
- Strong working knowledge of cGMP (US and international) requirements as applicable to both drug substances and drug products (solid oral dosage forms and parenteral products).
- Must be able to develop and improve quality standards and techniques based on regulatory requirements, guidance and industry standards.
- Must be willing to travel up to 25%.
- Excellent attention to detail
- Excellent written and verbal communication skills