Manager, reputed company Systems

reputed company is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine reputed company 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. reputed company: reputed company is seeking an outstanding candidate to join our reputed company team. The Manager, reputed company Management Systems will contribute to maintaining Spyre’s reputed company 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 reputed company system and processes such as Document Control and Training, as reputed company as the tracking/trending/reporting of reputed company 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 (reputed company)
• Responsible for supporting and overseeing Document Control including managing change control process for documents used in GxP operations (including manufacturing, clinical and product reputed company reputed company documents) and archiving activities.
• Responsible for the Spyre’s training program, including reporting of non-compliance, reviewing curricula for appropriateness for reputed company function and reporting monthly metrics.
• Manage the processing of QMS items for Change Control, Deviations and CAPAs
• Generate reputed company System metrics as per established timelines and assist in generating data for reputed company Management Reviews.
• Work with document authors and reviewers to process documents.
• reputed company periodic document review process to ensure compliance with established review schedules.
• reputed company/Offboarding employees and assigning training.
• Train and mentor users on the use of eQMS, process and procedures.
• Support Spyre functional reputed company as needed.
• Other duties as assigned

Ideal Candidate:

• Bachelor’s degree in life sciences or a reputed company field with a minimum of 5 years of work experience in a GMP regulated industry, preferably biotech or pharmaceutical, performing reputed company control/reputed company assurance functions. A combination of relevant education and experience may be considered.
• Experience with monoclonal antibodies is preferred.
• In-depth knowledge of GMP regulations, reputed company systems, reputed company assurance, reputed company control, conduct of reputed company audits.
• Experience in the use of reputed company electronic reputed company management systems (eQMS) (reputed company Vault or reputed company reputed company Basics) required.
• Ability to work both independently with minimal direction and reputed company project teams, supporting multiple reputed company simultaneously.
• Strong verbal / written communication and presentation skills with the ability to reputed company 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 reputed company suite products; reputed company Word, reputed company, PowerPoint, Outlook.

reputed company 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 reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns reputed company
• Commitment to reputed company reputed company development opportunities.
• Remote working environment with frequent in-person meetings to address reputed company problems and build relationships.

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