Manager, Quality Systems

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: Spyre Therapeutics is seeking an outstanding candidate to join our Quality team. The Manager, Quality Management Systems will contribute to maintaining Spyre’s Quality Management System in accordance with Spyre’s specific needs, regulatory requirements, and flexibility to support change and innovation. This role will drive establishment and improvements to GxP quality system and processes such as Document Control and Training, as well as the tracking/trending/reporting of Quality Metrics. This position will work closely with CMC, Clinical Development/Operations and Supply Chain functions. Key Responsibilities:

• 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

Ideal Candidate:

• 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.

What We Offer:

• 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.

The expected salary range offer for this role is $140,000 to $151,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location. As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/. Apply tot his job Apply To this Job