Senior QA Specialist - Compliance and Quality Systems
This role will support the development of quality systems, including SAP master data build, approvals, and ongoing updates. It will also involve the interface of SAP with product structure and manufacturing execution systems.
Key Responsibilities:
* Lead SAP master data build and approval activities, including hypercare, sustainment materials build, BOMs, and recipes.
* Collaborate with cross-functional teams to address compliance issues and achieve project milestones.
* Implement and train site quality systems and ensure compliance with the current quality manual requirements.
* Support completion of quality systems activities, such as documentation management, auditing, deviation management, change control, supplier management, and quality risk management.
* Create, maintain, and continuously improve quality management systems (QMS) and associated documentation.
* Develop and maintain assigned standard operating procedures (SOPs).
* Provide QA review and approval of change controls, deviations/CAPAs, SOPs, and related documentation for compliance to GMP and site requirements.
* Support site QA operations and validation colleagues as required.
* Foster strong relationships with management and colleagues to drive a safe and compliant culture.
* Gather site metrics and escalate compliance risks to management in a timely manner.
Experience and Education:
* Bachelor's degree in a scientific or quality-related field.
* 2-3 years' experience in an FDA/EMA-regulated environment, preferably in quality assurance, quality control, or technical operations within the biological and pharmaceutical industry.
* Previous experience in QMS development and maintenance, quality risk management, SQM, deviations, and change control.
* Knowledge of quality management systems such as Veeva, SAP, Delta-V, TrackWise, PAS-X, or similar.