Senior Manager, Quality Management Systems

Role Summary:

The Sr. 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 Change Control, Deviation, CAPAs, Product Quality Complaints and Training, as well as the tracking/trending/reporting of Quality Metrics. This position will work closely with Manufacturing, Quality Control, QA Operations and Supply Chain functions.

  Key Responsibilities:

• Create and Implement Quality Systems business processes and author SOPs and Work Instructions for eQMS system
• Execute User Acceptance Testing (UAT) scripts and validation documents
• Manage, oversee day-to-day operations and lead continuous improvement efforts of eQMS including Change Control, Document Control, CAPA, Deviation, Training, Product Customer Complaints and Audit Management
• Responsible for supporting and overseeing Document Control including managing change control process for documents used in GxP operations (includes manufacturing, clinical and product quality related documents) and archiving activities
• Develop and implement Quality Systems and procedures including SOPs, policies, forms, and reporting tools
• 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 document changes 
• Oversee periodic document review process to ensure compliance with established review schedules
• Train and mentor users on the use of eQMS process and procedures
• Conduct GXP Training
• Responsible for on/offboarding of employees
• Maintain company training records, report out monthly training metrics
• Represent Quality Assurance at cross functional meetings and serve as the subject matter expert for quality system requirements for technical teams.
• Participate in internal audits and regulatory inspections, including managing and coordinating logistics
• Responsible for the efficient management of quality systems in support of product regulatory strategies
• Other duties as assigned

Ideal Candidate:

• Bachelor’s degree in life sciences or a related field with a minimum of 8 years of work experience in a GXP setting (an equivalent combination of education and experience may be considered).  
• Expert knowledge of Quality Management Systems in a cGXP manufacturing environment (Veeva Systems, ZenQMS, etc.)
• Ability to write SOP’s, business correspondence, and procedure manuals
• Demonstrated ability to work in a fluid, dynamic and fast-paced environment
• Demonstrated ability to work simultaneously on multiple projects, and to deliver high-quality work according to timelines
• Detail oriented with strong written and verbal communication skills
• Proficient in Microsoft suite products; Microsoft Word, Excel, PowerPoint, Outlook
• Ability to work independently, within prescribed guidelines, or as a team member
• Demonstrable team leadership, problem solving, creative and critical thinking and project planning skills
• Displays high competence in the utilization of core quality systems such as Change Control, Deviations, Product Complaints, CAPA management, Document Control and Training
• Computer System Validation experience preferred, but not required

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 $166,000 to $190,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.