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Engineering for new heights in the treatment of inflammatory bowel disease
Manager, Quality Systems
Location
United States
Posted
123 days ago
Salary
$140K - $151K / year
Seniority
Senior
Job Description
Manager, Quality Systems
Spyre Therapeutics
• 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
Job 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.
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