The Quality Assurance Manager is responsible for defined aspects of the day-to-day operational activities of the Quality Assurance function in the Company. This role will demonstrate capabilities across the entire spectrum of quality systems internally and external to the company (with internal stakeholders, contract service providers, customers,..). The GxP Quality Assurance Manager position will implement, troubleshoot, and continuously improved processes, conduct/approve deviations, investigations, non-conformances, corrective and preventive actions (CAPA), change controls. Coordination, conduction and management of the full process of audits (internal and external) is a key responsibility of the role.
Lead risk management initiatives including risk assessment of key processes and changes and track and trend of data. Provide training for functional teams, support, and escalate compliance issues to senior management in a timely manner. This is a highly visible role with responsibility and cross-functional influence that has an impact on organization performance and broad quality initiatives requiring primarily tactical decision making.
The role encompasses also responsibility of the company Regulatory Affairs management, with direct responsibility of preparation, submission and maintenance of company multiple certifications, authorizations and accreditations, interacting on behalf of the company with multiple bodies, including institutional entities.
Participate proactively in European QA integration initiative and related activities, contributing to the development of improved practices and policies in this broader scope.
Essential Functions of the Job:
- Train and encourage the growth of QA team resources
- Oversight of Quality Management System all processes related to Deviations, CAPA’s Change Control, Complaints, Risk Management, etc.
- Leads and manages change controls, client complaints, deviations, CAPA’s, investigations, and nonconformances
- Monitors, evaluates and manages Quality Standard Operating Procedures (SOPs) for continuous improvement of the Quality Department
- Assess and revise, as needed, SOPs and identify opportunities to streamline systems and processes
- Provide Quality guidance of GxP for operations and cross functional groups to ensure compliance with KPI targets
- Monitor performance metrics and drive continuous improvements of internal processes
- Directly discuss and execute Quality Agreements with clients and suppliers, including the entire process for monitoring periodic review
- Support regulatory filings and inspection as needed
- Representation of QA at all levels of the organization by providing GxP guidance
- Participates/Leads multifunctional project teams to assure that processes/services are compliant and introduced in accordance with requirements and meet Quality System requirements
- Participates/Leads international corporate QA integration and harmonization initiatives
- Assist in risk identification, tracking and planning for mitigation of risks
- Provide Quality support to implement robust and transparent Quality Governance review processes such as Quality Management System Review.
