The Sr. Associate, Quality Systems supports and maintains GMP compliance by providing oversight and execution within key Quality Systems, including Deviations, CAPAs, Change Controls, Laboratory Investigations, Risk Management, Equipment Compliance, and Method Qualification. This role leads and supports cross-functional investigations, ensures timely and compliant documentation, and partners with internal teams to drive continuous Quality System improvement. The position works closely with Manufacturing, QC, Analytical Development, and other functions to promote a proactive quality culture and operational excellence.
Responsibilities- Provides oversight and ownership of assigned Quality Systems, including Deviations, CAPAs, Change Controls, Laboratory Investigations, and Risk Management.
- Leads and supports cross-functional investigations to identify root cause, assess impact, and define effective corrective and preventive actions.
- Develops new Quality Systems and improves existing systems to enhance compliance, efficiency, and program effectiveness.
- Generates and assesses monthly, quarterly, and annual Quality System metrics to monitor performance against key performance indicators (KPIs), identify trends, and drive continuous improvement.
- Manages initiation, execution, review, approval, tracking, and trending of assigned Quality System records to ensure compliance and timely closure.
- Performs QA review and approval of method qualification protocols and reports, method revisions, Certificates of Analysis, and other QC/Analytical Development documentation.
- Supports GMP equipment onboarding and qualification through QA review and alignment with internal requirements.
- Conducts QA review and approval of GMP documents and quality records for accuracy, completeness, clarity, and procedural compliance.
- Collaborates with Manufacturing, QC, Analytical Development, Engineering, and other groups to support a proactive quality culture and continuous improvement.
- Contributes to site quality initiatives, operational efficiency projects, and activities related to technology transfer and commercialization.
- Assists other Quality groups as needed, including document control, training, audits, batch disposition, and manufacturing QA support.
- Communicates effectively with supervisors, colleagues, and teams.
- Participates as a team member in all aspects of Abzena's business.
- Adheres to regulatory and Abzena quality standards, policies, procedures, and mission.
- Maintain the highest ethical and moral standards
Qualifications- Bachelor's degree in science or engineering or equivalent with 5-8 years of relevant experience in the Pharmaceutical, Biologic, Biotechnology, or Medical Device space.
- Relevant experience as in Quality Assurance, Quality Systems, Quality Compliance, Quality Control, GMP manufacturing and testing.
- Experienced in leading Root Cause Analysis investigations, developing corrective actions, and performing risk assessments.
- Experienced in early-phase to commercial quality systems development and maintenance.
- Adequate knowledge of industry standards and regulation requirements for biologics and small molecules in clinical development and commercial.
- Adequate knowledge of GMP regulations (e.g. US, EU, and ROW), good documentation practices, cGMP, 21CFR Part 210 and 211, USP and other applicable regulations, standards, and guidance.
FLSA: Exempt
