Quality Oversight of Cold Chain Operations, which includes establishing and managing quality control measures to ensure suitability of systems, vendor onboarding and oversight, process/systems validation, non-conformance investigation/CAPA, risk management:
The assignment will include reviews of Eversana’s Cold Chain risk management process to identify gaps and to implement improvements. The individual will facilitate/or performs:
Quality Systems management of Cold Chain processes (e.g. SOP development and compliance). Quality management oversight and issue escalation of Cold Chain processes. Quality management of Urgent access vendor onboarding, quality agreements, validation, and qualification. Review Cold Chain verification & validation plans, testing, and test reports; identify and implement improvements in our Cold Chain Validation processes. Analyzes non-conformances, trends, and corrective/preventive actions (CAPAs) related to Eversana’s Cold Chain processes to identify and implement improvement opportunities. Leading and/or participating in the development of the risk management process for Eversana’s Cold Chain processes. Analyze processing errors (receiving, put-away, inventory control, picking, packing, and shipping) within Eversana’s Cold Chain processes. Travel (25% or number of days) Hours (40 work week)
Education: Bachelor's degree
Experience and/or Training: Minimum 2+ years in quality assurance in GxP environment (i.e. GVP, GCP, GDP, GAP). Experience in conducting internal and external audits.
Ability to communicate effectively at all levels of the organization and with key client and vendor stakeholders
Positive Attitude and Energy – Exhibits an upbeat attitude, a genuine interest in others and a sense of humor. Energizes others and heightens morale through her/his attitude.
Communication Skills – Possesses the ability to develop and articulate ideas and information that generate understanding and creates a climate that motivates and encourages others to participate.
Innovator – Transforms creative ideas into original solutions that positively impact the company’s performance.
Highly Principled – Proves to be a professional of unquestionable integrity, credibility and character who demonstrates high moral and ethical behavior.
Education: Bachelor's degree in life sciences discipline
Experience and/or Training: Experience in leading Pharma 3PL Quality Assurance Activities. Experience in designing and implementing quality systems and procedures and audit conduct/readiness for the pharmaceutical and biotechnology industries. Cold Chain Validation and thermal Mapping experience.
Licenses/Certificates: Industry Quality Certifications (ASQ) CMQ/OE