Title: Director of GCP Quality Assurance
Location: Waltham, MA
Entasis Therapeutic is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ targeted-design platform has produced a pipeline of product candidates, including ETX2514SUL (targeting A. baumannii infections) being initiated for Phase 3 clinical trials, zoliflodacin (targeting Neisseria gonorrhoeae) being initiated for Phase 3 clinical trials, and ETX0282CPDP (targeting Enterobacteriaceae infections). Entasis is also using its platform to develop a novel class of antibiotics, non-β-lactam inhibitors of the penicillin-binding proteins (NBPs) (targeting Gram-negative infections).
The Director of GCP Quality Assurance is responsible for clinical and medical quality assurance, quality control and quality compliance and training operations. The Director of QA will establish, maintain and ensure effectiveness of the quality programs and documentation to assure compliance in a GxP regulatory environment. He/she will establish quality plans and policies and report to executive management on a regular basis on quality compliance activities and findings. The Director of QA will design, implement, maintain QA and compliance programs and infrastructure including a Standard Operating Procedures (SOP) system, training program. The Director of QA will also perform internal and external audits and serve as the internal advisor on GxP compliance.
- Design and maintain QA and GCP compliance for all aspects of Entasis programs to support R&D, clinical studies, and future product registration.
- Review and provide guidance and advice on the development and implementation of QA/QC SOPs and policies.
- Develop, implement and oversee training programs to ensure compliance with GCP and ICH requirements.
- Provide GCP QA oversight of vendors and maintain quality agreements.
- Oversee GCP auditing program to fulfill regulatory requirements.
- Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, and Entasis policies and procedures.
- Provide strategy QA input to company’s product development goals, including quality audit plans and budgets.
- Minimum of BS, MS or PhD in a relevant technical field.
- 5-10 yrs. of relevant work experience in pharmaceutical QA required.
- Solid and demonstrable knowledge of GcP regulations, guidelines and experience implementing QA systems.
- Attention to detail with an ability to perform critical review of various types of documents.
- Strong organization and time management skills.
- Demonstrated ability to work as a team player with multi-disciplinary project teams.
- Ability to independently solve problems and work cross-discipline.