Senior QA Systems Specialist - Inozyme Pharma

Title: Senior QA Systems Specialist

About Inozyme Pharma:

Inozyme Pharma is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics for rare diseases that affect bone health and blood vessel function. We are experts in the PPi-Adenosine Pathway, where the ENPP1 enzyme generates inorganic pyrophosphate (PPi), which regulates mineralization, and adenosine, which controls intimal proliferation (the overgrowth of smooth muscle cells inside blood vessels). Disruptions in this pathway impact the levels of these molecules, leading to severe musculoskeletal, cardiovascular, and neurological conditions, including ENPP1 Deficiency, ABCC6 Deficiency, calciphylaxis, and ossification of the posterior longitudinal ligament (OPLL).

Our lead candidate, INZ-701, is an ENPP1 Fc fusion protein enzyme replacement therapy (ERT) designed to increase PPi and adenosine, enabling the potential treatment of multiple diseases caused by deficiencies in these molecules. It is currently in clinical development for the treatment of ENPP1 Deficiency, ABCC6 Deficiency, and calciphylaxis. By targeting the PPi-Adenosine Pathway, INZ-701 aims to correct pathological mineralization and intimal proliferation, addressing the significant morbidity and mortality in these devastating diseases.

Position Overview:

Inozyme is looking to fill a critical role within the Quality Assurance team with an experienced professional who will oversee, develop, and manage Inozyme’s electronic document control management system as well as provide support to ongoing operations and Quality improvement initiatives. As a company in late-stage clinical development, Inozyme offers an exciting environment characterized by rapid growth and the opportunity to make meaningful contributions to scale systems while implementing creative and effective solutions to enhance operational efficiency.

The ideal candidate will have experience in the management of electronic document management systems (EDMS) used to support GXP operations. This position is an excellent fit for seasoned professionals in Quality Assurance and Document Control or those with a strong GMP/CMC background who can leverage their expertise to drive innovation and operational excellence in document workflows. Interested candidates who may not have direct experience in traditional Quality roles but who have expertise in administering productivity tools that enhance operational organization, tracking, and inter/intra-departmental communication and collaboration are encouraged to apply, as their skills could align well with the innovative and collaborative aspects of this role.

The successful candidate will work to ensure internal compliance with 21 CFR Parts 11, 210, and 211 while supporting Sponsor (Inozyme) oversight and collaborations with qualified third-party vendors and contract service providers (e.g., CMO’s, CRO’s) operating in the highly regulated GCP/GMP/GLP life sciences space. This position will play a critical role in enhancing and streamlining document systems and workflows while also contributing to the continued development and enhancement of robust Quality Management Systems.

Reporting Relationship: This person will report into our Senior Quality Assurance Manager

Essential Duties and Responsibilities:

• Administers the EDMS and overall Document Control function for supporting quality operations, ensuring compliant document generation, distribution, periodic review, and version control.
• Tracks and monitors open departures (deviations, CAPA, change control, product complaints) within the EDMS. Assists the clinical and CMC development teams with departure initiation and workflows.
• Administers and oversees employee training requirements and generates training compliance metrics. Works with cross-functional department Leads to ensure appropriate training curricula are assigned.
• Supports supplier qualification and audit lifecycle management activities. Maintains the Qualified Vendor List.
• Develops and optimizes workflows, trackers, dashboards, and user guides to support QA operations and inter/intra-department communication.
• Supports SOP review, approval, distribution and training functions. Tracks and ensures the execution of periodic reviews. Ensures consistency in SOP format, metadata, and document references.
• Reviews and approves batch records for packaging and labeling of drug product.
• Administers new employee Quality Assurance orientation and onboarding.
• Archives vendor GXP documentation within controlled access SharePoint.

Education and Qualifications:

• 7+ years experience administering quality management systems or in related roles such as CMC operations, GMP-compliant manufacturing, or pharmaceutical project management.
• A four-year degree is preferred; however, a two-year technical degree may be acceptable with an appropriate level of experience.
• Experience administering or operating within Electronic Document Management software is required (e.g., ZenQMS, MasterControl, Veeva, etc.).
• Experience designing operational systems, workflows, and trackers using productivity and project management tools is highly desirable.
• Proficiency with MS Office software.
• Self-starter attitude with a proactive, results-oriented focus and willingness to assume additional responsibilities as needed.
• Strong time management skills to successfully complete a variety of job duties and responsibilities in a timely manner.
• Must be able to engage with a variety of people with different technical levels and educational backgrounds.
• Willing to work onsite 2 - 3 days per week with the ability to work from home when not in the office.