Title: Director of GMP Quality Assurance
Location: Waltham, MA
Entasis Therapeutics 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 SUL-DUR (targeting A. baumannii infections) being evaluated in Phase 3 clinical trials, zoliflodacin (targeting Neisseria gonorrhoeae) being evaluated in 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 GMP Quality Assurance is responsible for GMP quality assurance, quality control, 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. The candidate will be responsible for implementing commercialization strategies to maintain compliant manufacturing operations. He/she will work closely with the Chemistry Manufacturing and Controls (CMC) Team, to ensure full support of GMP activities. He/she will establish quality plans and policies and report to the Sr. Director/Head of Quality 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 (SOPs) system and training program. The Director of QA will oversee internal and external GMP audits and serve as the internal advisor on GxP compliance.
- Establish and maintain the quality management system (QMS) to include vendor management plans, oversight of external GMP vendors (Quality agreements, audits, batch release documentation), SOPs and training.
- Material Review and oversight of development and future commercial contract manufacturing organization (CMO) investigations (deviations, out-of-specification/out-of-trend, change control, and complaints). Obtain and oversee to closure corrective actions from CMOs.
- Responsible for implementing, supporting, and overseeing a document control system, including document review, approval, release, change control, and archiving activities.
- Develop, implement, and oversee training programs to ensure compliance with GxP and ICH requirements. Continue to develop and maintain external manufacturing audit program.
- Ensure adherence to applicable regulations including FDA, EMA, ICH, GMP and Entasis policies and procedures.
- Lead inspection readiness and PAI activities.
- Design and maintain QA and GMP compliance for all aspects of Entasis’ programs to support clinical studies, pharmaceutical development, product registration, validation, and future commercial manufacture.
- Review batch documentation and compliant release of drug substance and drug product batches to support current development and future commercial supply chain requirements.
- Minimum of BS, MS, or PhD in a relevant technical field.
- Minimum 15 yrs. of relevant work experience in pharmaceutical industry QA required.
- Direct experience working and/or supporting cGMP manufacturing activities and/or CMC.
- Solid and demonstrable knowledge of GxP regulations, guidelines, and experience implementing QMS.
- Attention to detail with an ability to perform critical review of pharmaceutical development and manufacturing documentation.
- 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-functionally.