Manager, Quality Systems

Job Description: • Manage and maintain a compliant Document Control System (Veeva) • Responsible for supporting and overseeing Document Control including managing change control process for documents used in GxP operations (including manufacturing, clinical and product quality related documents) and archiving activities. • Responsible for the Spyre’s training program, including reporting of non-compliance, reviewing curricula for appropriateness for each function and reporting monthly metrics. • Manage the processing of QMS items for Change Control, Deviations and CAPAs • Generate Quality System metrics as per established timelines and assist in generating data for Quality Management Reviews. • Work with document authors and reviewers to process documents. • Oversee periodic document review process to ensure compliance with established review schedules. • Onboarding/Offboarding employees and assigning training. • Train and mentor users on the use of eQMS, process and procedures. • Support Spyre functional groups as needed. • Other duties as assigned Requirements: • Bachelor’s degree in life sciences or a related field with a minimum of 5 years of work experience in a GMP regulated industry, preferably biotech or pharmaceutical, performing quality control/quality assurance functions. A combination of relevant education and experience may be considered. • Experience with monoclonal antibodies is preferred. • In-depth knowledge of GMP regulations, quality systems, quality assurance, quality control, conduct of quality audits. • Experience in the use of Veeva electronic quality management systems (eQMS) (Veeva Vault or Veeva Quality Basics) required. • Ability to work both independently with minimal direction and within project teams, supporting multiple projects simultaneously. • Strong verbal / written communication and presentation skills with the ability to interact professionally with a diverse group of stakeholders, senior managers, and subject matter experts including contract service providers, strategic partners, and regulatory organizations. • Demonstrated ability to work in a fluid, dynamic and fast-paced environment. • Proficient in Microsoft suite products; Microsoft Word, Excel, PowerPoint, Outlook. Benefits: • Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. • Unlimited PTO • Two, one-week company-wide shutdowns each • Commitment to provide professional development opportunities. • Remote working environment with frequent in-person meetings to address complex problems and build relationships. Apply tot his job Apply To this Job