Title: GMP Quality Assurance Manager
Location: Waltham, MA
Entasis Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel antibacterial products to treat urgent and serious infections as prioritized by the CDC and WHO. The innovative and robust pipeline include two late-stage programs against highest-priority pathogens - sulbactam-durlobactam (SUL-DUR) (targeting A. baumannii infections), which has completed phase III and zoliflodacin (targeting Neisseria gonorrhoeae) that is nearing phase III completion. Three additional programs in early-stage development include ETX0462 against Pseudomonas aeruginosa, ETX0282CPDP against MDR cUTIs, and NBP2 for Gram (-) infections.
The Good Manufacturing Practice (GMP) Quality Assurance Manager is responsible for supporting GMP quality assurance, quality compliance, and daily operations. Reporting to the Director of GMP QA, the GMP Quality Assurance Manager will execute against quality programs and documentation to assure compliance in a GMP regulatory environment. He/she will work closely with the Chemistry Manufacturing and Controls (CMC) Team to ensure support of GMP manufacturing and analytical activities, as well as provide quality and compliance guidance. He/she will provide assurance over internal activities as well as quality oversight of contract manufacturers, suppliers, and service providers.
- Review and approval of development and analytical protocols, reports, methods, and specifications.
- Review of master and executed batch documentation and assurance of compliant release of drug substance and drug product batches to support current development, validation, and future commercial supply chain requirements.
- Collaborate with CMC and contract manufacturers to evaluate and address complex issues such as deviations, OOSs, corrective and preventive actions (CAPA), change control, and failure investigations.
- Support/management of the supplier qualification program, including vendor qualification and vendor audits.
- Author, review, and /or approve Policies, SOPs, Forms, and Templates in compliance with document control system requirements, as needed.
- Ensure adherence to applicable regulations including FDA, EMA, ICH, GMP and Entasis policies and procedures.
- Actively participate in inspection readiness and PAI activities; perform internal audits.
- Minimum of BS, MS, or PhD in a relevant technical field.
- Minimum BS- 8, MS- 7, or PhD- 5 years 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 GMP regulations, guidelines, quality principles, industry practices, and standards.
- Attention to detail with an ability to perform critical review of pharmaceutical development, manufacturing, and analytical documentation.
- Shows strong initiative and independence. Able to perform routine work and fulfill responsibilities with little or no additional instruction.
- Demonstrated ability to work as a team player with multi-disciplinary project teams.
- Ability to manage multiple projects in a fast-paced environment, project management experience a plus.
- Experience working with CMOs, vendors, and relationship management preferred.
- Knowledge of late-stage pharmaceutical development and validation principles preferred.
- Excellent judgment and ability to communicate complex issues in an understandable way.
- Outstanding communication skills (verbal and written).
Entasis is proud to be named one of the BEST workplaces in HealthCare and Biopharma by the Great Place to Work Institute and Fortune Magazine! https://www.greatplacetowork.com/certified-company/7022538
Entasis offers a comprehensive benefits package to all eligible employees including health, dental, vision, 401(k), Health Savings Account, Employee Assistance Program, Short/Long Term Disability Insurance, and Paid Time Off.
Entasis is an equal opportunity workplace and participates in E-Verify. We welcome diversity and are committed to creating an inclusive environment for all employees. All employment is decided on the basis of qualifications, merit, and business need. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status or any other status protected by law.
Entasis considers the health and safety of it’s employees and community a top priority. To be employed by Entasis you will be required to be fully vaccinated or to have met the legal criteria for a reasonable accommodation. If you have any questions or concerns, please discuss them with your recruiter during the application/interview process.