Typical Accountabilities:
• Support specific quality system processes within assigned site / area.
• Assist in maintenance process governance structures within a site to ensure processes are properly documented, reviewed, and updated as necessary.
• Support analysis of process and data trends, and optimization of existing site processes.
• Provide guidance and support to cross-functional teams to address needs as related to own area (e.g. risk management, compliance, inspection readiness, investigation responses).
• Support oversight and management of learning management systems related to PQS within site / area.
• Collaborate with other quality systems colleagues to drive joint simplification and improvement work.
• Participate in audits, inspections, and response processes as applicable.
• Engage with cross-functional stakeholders within site for assistance in defense and responses, and share observations and learnings, as applicable.
• Support development / change and implementation of SOPs within area of responsibility.

Education, Qualifications, Skills and Experience

Essential:
• Entry level bachelor’s degree in science / engineering field such as Pharmacy, Biology, or Chemistry.
• Experience with pharmaceutical manufacturing and quality.
• Strong orientation for continuous improvement and process streamlining and optimization.

Desirable:
• Some experience in business process / quality system management preferred.
• Experience applying Lean principles and supporting change initiatives within a structured framework preferred.
• Knowledge of / experience with newer digital tools 
and technologies related to quality systems management preferred.