Associate Director, Quality Assurance and Quality Systems
About The Position
Angitia is seeking an experienced and strategic Associate Director of Quality Assurance, Quality Systems to be a critical member of our Quality Leadership Team to lead the development, execution, and continuous improvement of Angitia’s GxP Quality Systems. This leader will oversee the implementation and maintenance of Angitia’s electronic Quality Management System (eQMS) and serve as the business process owner for critical modules including document control, training, deviations, CAPA, and change control. The role is accountable for driving the maturation of our Quality Systems and processes to support Angitia’s transition towards readiness for global pivotal clinical studies and subsequently maintaining inspection ready Quality Systems that support clinical development, external manufacturing, and evolving regulatory expectations. The ideal candidate brings deep breadth of experience operating within a nimble, resource constrained biotech environment and thrives on building scalable processes, driving cross functional alignment, and elevating the culture of quality as the organization progresses toward late-stage clinical development and commercialization.
Requirements
- Degree in Chemistry, Biochemistry, Molecular Biology, or related field.
- 8+ years of experience in Quality Assurance within biotech/pharma, with strong preference for experience in both clinical and commercial settings.
- Strong, hands‑on leadership and operational experience with GxP Quality Systems in a clinical‑stage biotech environment.
- Demonstrated expertise with eQMS platforms including system ownership and module configuration.
- Deep knowledge of FDA, EMA, and ICH regulations and guidance applicable to clinical development, cGMP for external manufacturing, and computerized systems.
- Proven experience managing document control, training, deviation/CAPA, and change control processes.
- Quality Operations experience including deviation and change control Quality Approvals, batch disposition, etc.
- Proven ability to lead cross-functional teams and influence without direct authority.
- Exceptional organizational, communication, and strategic thinking skills.
Nice To Haves
- Experience supporting regulatory inspections (FDA, EMA, MHRA or equivalent).
- Experience working with external partners including CMOs, CDMOs, and CROs.
- Experience implementing or upgrading an eQMS.
Responsibilities
- Provide strategic leadership and hands-on oversight for the GxP Quality Management System, ensuring compliance with FDA, EMA, and ICH guidelines relevant to clinical‑stage activities.
- Own the eQMS and its core modules, including governance, optimization, user support, and coordination with IT, internal stakeholders, and vendors.
- Lead document management processes, ensuring controlled documents (SOPs, policies, forms, work instructions) are current, accurate, and aligned with clinical and CMO/CRO operations.
- Oversee the GxP training program, including role‑based curricula, onboarding, training effectiveness, and system performance within the eQMS.
- Direct the deviation and nonconformance process, ensuring high quality investigations, root cause analysis, and effective corrective and preventive actions.
- Own the CAPA system, ensuring quality issues are captured, assessed, prioritized, and addressed with clear plans and effectiveness checks.
- Manage change control processes for GxP documents, quality systems, and relevant operational changes.
- Establish, monitor, and communicate Quality System KPIs to senior leadership; identify trends and drive proactive improvements.
- Support internal and external audits, regulatory inspections, and inspection readiness activities.
- Collaborate with CMO, CDMO, and CRO partners to ensure alignment and oversight of Quality System expectations, documentation, and compliance.
- Contribute to Quality strategy and governance as the company advances into later‑stage clinical studies and early commercial readiness.
Benefits
- Medical, dental, and vision coverage for employees and their eligible dependents
- 401(K) Retirement Plan with Company match
- Company paid Long Term Disability Coverage
- Company-paid life Insurance & AD&D Coverage
- Voluntary Life Insurance & AD&D Coverage
- Employee Assistance Program (EAP)
- Company-paid Holidays
- Vacation
- Paid Sick Leave
- Telecommunication Monthly Stipend
- Work-From-Home Equipment Reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Senior
