Manager, Quality Assurance

Spero Therapeutics
Full time Full day
Cambridge, MA
About Us : Spero Therapeutics (Nasdaq: SPRO) is a multi-asset pre-commercial stage biopharmaceutical company in Cambridge, Mass. We are highly committed to advancing novel treatment approaches for bacterial infections with a world-class team of biotechnological and biopharmaceutical experts. The company has a pipeline of novel and highly differentiated antibacterial and rare disease product candidates focused on patients' unmet needs with multi-drug resistant (MDR) bacterial infections. Spero’s lead product candidate, tebipenem HBr, is an oral carbapenem being developed as the first oral carbapenem antibiotic for use in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). In September 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in cUTI and AP, and in October 2021, Spero filed a new drug application for tebipenem HBr in these indications. Spero is also developing SPR720, its oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease, a rare orphan disease. Spero’s third product candidate, SPR206, is an IV-administered agent being developed as an innovative option to treat MDR Gram-negative bacterial infections. We believe that our novel product candidates will have a meaningful impact on patient health and significant commercial applications for treating MDR infections in hospitals and community settings. Overview:

The Manager of Quality Assurance (QA) will assist with the propagation and implementation of the Good Manufacturing Practices (GMP) Quality processes. The candidate will provide hands-on support for QA activities related to clinical supply products and preparing for commercial products. The individual will work cross-functionally across the internal CMC (Chemical, Manufacturing and Control), Clinical, Regulatory teams and with external counterparts within the contract organizations. The candidate will start out as an individual contributor with the potential to lead a team. The QA Manager will report to the Head of Quality
What you'll do:
  • Review of SOPs, protocols/master batch records, reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards, and corporate policies and Spero internal procedures

  • Convene material review boards and generate product impact assessments

  • Contribute to the development of quality systems and procedures to ensure compliance with all cGxP activities

  • Develop quality metrics and provide status reports metrics to department and management

  • Have a fundamental grasp of the drug development processes and scientific methods

  • Demonstrate strong leadership skills and experience working with all levels of management

  • Author and revise Spero controlled documents

  • Contribute to preparation and review of regulatory filings

  • Support vendor qualification

  • Perform vendor audits

  • Perform batch record review
  • Review investigations and provides inputs into CAPAs

  • Perform review of Quality Agreements and other technical agreements

  • Manage chain-of-identity and chain-of-custody of all clinical materials, including starting materials

What you'll need:
  • BS/BA in scientific discipline or related field and a minimum of 5 years relevant experience

  • Requires strong written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally

  • Ability to handle multiple assignments and changing priorities

  • Understanding of the application of cGMPs to early development and commercial products, FDA regulations and ICH guidelines required

  • Special knowledge and/or licenses or certifications

  • Knowledge of MS Office (Excel, Word, PowerPoint, Outlook) and knowledge of DocuSign is a plus

  • Desire and ability to work in a fast-paced open environment

  • Travel up to 20%

EEO & Culture Statement: By joining our committed and highly motivated team, you’ll experience a workplace culture that is inclusive, fair, challenging, supportive, and respectful. Spero’s culture is one that emphasizes “servant leadership,” or putting ego aside and working for the benefit of the team and our patients, and values our colleagues’ opinions and celebrates accomplishments in service of patients. As a federal contractor, Spero Therapeutics is required to comply with Executive Order 14042, which requires all employees to be vaccinated against COVID-19 absent a bona fide medical reason or genuine religious belief relating to vaccinations. All employees must be in compliance with Spero Therapeutics’ COVID-19 vaccine policy prior to the commencement of their employment. Spero Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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