Spero Therapeutics Director, Quality Systems in Cambridge, Massachusetts
Spero Therapeutics (Nasdaq: SPRO) is a multi-asset clinical 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 the unmet needs of patients with multi-drug resistant (MDR) bacterial infections. Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide, formerly SPR994), is designed to be the first oral carbapenem antibiotic for use in adults to treat serious bacterial infections, including those caused by MDR Gram-negative infections. In September 2020, Spero announced positive top-line results from its Phase 3 ADAPT-PO clinical trial of tebipenem HBr in complicated urinary tract infection and acute pyelonephritis. Spero is also advancing 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 sincerely believe that our novel product candidates will have meaningful impact on patient health and significant commercial applications for the treatment of MDR infections in both the hospital and community settings.
General Scope and Summary of Role
Spero Therapeutics is looking for a collaborative, enthusiastic partner responsible for oversight of Spero’s Document Control and Training systems. This is a newly created role due to growth of the company. This is a great opportunity to be a key contributor of a high-performance team.
The successful candidate will play an essential role in developing and maintaining quality systems that support and ensure GxP compliance, including the document management system, training systems, GxP vendor management, change control, CAPA systems, and metrics reporting for Quality Management Review.
What You'll Do
Develop a long-term compliance strategy for Quality System design and growth.
Partner with and influence key personnel to align and facilitate harmonization of strategy, procedures, and processes related to the quality management system in a phase appropriate manner.
Provide hands-on expertise in the day-to-day management of data and document control within the GxP Quality Management System using digital and paper-based solutions. This includes all aspects of document changes (document review, approval, release, and retention), change control, investigations and CAPAs.
Develop, implement and oversee training programs to ensure compliance with GxP and ICH requirements. Continue to develop and maintain external manufacturing audit program.
Manage other key processes and SOPs (Investigation, CAPA, Quality/Operational Risk Management, Internal Audits, Supplier Audits, and Inspection Readiness)
Manage the Supplier Management program, which includes the supplier selection, qualification and approval process, maintenance of the Approved Supplier List, and oversee the creation and response to supplier questionnaires.
Establish and monitor quality indicators for GXP-related functional areas within the organization. Issue reports and escalate significant issues to Executive Management, as required
Prepare data and actively participate in Management Reviews and Quality Improvement efforts
Collaborate with other subject matter experts across the organization to conduct cross-functional investigations, risk management and mitigation plans.
Support creation of automated workflows in the Veeva Vault QMS Quality Management System
Provide support to implementation of Veeva Vault QMS
Work with IT to identify and implement tools and systems to improve efficiency.
Communicate milestones and planned changes to the user community regarding Quality Management System and Compliance initiatives.
What You'll Need
BS/BA in scientific discipline or related field and a minimum of 10 years relevant experience
Understanding of the application of cGMPs to early development and commercial products, FDA regulations and ICH guidelines required
Knowledge of Veeva
Desire and ability to work in a fast-paced open environment.
Must possess good organizational skills and attention to detail.
Requires strong written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
Ability to handle multiple assignments and changing priorities.
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.
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