Senior Manager, GMP Quality Assurance

Role Summary:

Spyre Therapeutics is seeking an exceptional Sr. Manager, GMP Quality Assurance to join our Quality team. This individual will have the unique opportunity to assist the Sr. Director, GMP QA in developing, monitoring, and maintaining all aspects of a quality system as it relates to cGMP requirements for a development and clinical phase organization pursuing multiple biologic monoclonal antibody candidates. This person will be responsible for Batch Release, Change Control, Qualifications, Deviations and CAPAs as they relate to the CMOs and the production clinical drug substance and drug product. This role reports to the Sr. Director of GMP QA.

  Key Responsibilities:

• Manage and coordinate Quality Assurance related activities relating to the CMOs and TechOps teams as well as support the QA team in a regulated environment
• Support implementation of the Spyre Therapeutics’ quality strategy and culture
• Perform batch record review and product release activities to ensure all products released meet regulatory standards
• Assist with the creation of quality metrics related to the trending of non-conformance reports, CAPAs, and complaint investigations
• Review and approve master batch records, analytical methods, validation and cleaning protocols and reports, standard operating procedures (SOPs), change control documents, Quality Events, etc. as needed
• Review Stability Protocols and resulting Data and Reports for compliance when required
• Work with Quality Operations to ensure compliance with the company’s corporate Quality Management System (QMS)
• Effectively collaborates with departments (i.e. Technical Operations, CMC Regulatory and Clinical) on various projects/improvements when input/participation from Quality is needed
• Participate in specific Quality related projects in accordance with the company’s goals and business objectives
• Drive the spirit of teamwork across all functions by supporting a team approach with focus on our patients being the top priority
• Support regulatory authority inspections and partner audits
• Align daily actions with department goals and company culture
• Other duties as assigned

Ideal Candidate:

• Bachelor’s degree in a scientific discipline with 8 plus years in the Pharmaceutical/Biotechnology industry (an equivalent combination of education and experience may be considered)
• Proven ability to apply cGMP regulations 21 CFR Part 11, 210, 211, 600 and good documentation practices to daily activities governing the Spyre activities
• Clinical product batch release experience required; commercial product release is a plus
• Experience in investigations writing and review required
• Experience with third party testing vendors and quality control release assays is a plus
• Knowledge of a biologics manufacturing and fill/finish environment strongly preferred
• Detail oriented with strong written and verbal communication skills
• Ability to work independently with minimal direction, within prescribed guidelines, or as a team member
• Ability to work well in a deadline-driven environment
• Travel may be required up to 15% of the time

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 $165,000 to $182,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.