- Assist with the integration and support of quality regulations: drug, biologics, device and/or combination products.
- Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems. Evaluate, analyze and trend quality indicators, data and performance metrics; communication and elevation of affiliate compliance status and risk while maintaining a continuous improvement objective.
- Partner, coordinate and support activities related to product actions in the affiliate.
- Assist project teams in planning, preparation, review and approval of quality documentation. Coordinate the Management Review process for the affiliate.
- Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements. Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
- Participate in training and education programs for various aspects of quality assurance.
- Coordinate and investigate quality events such as deviations, non conformances, product complaints and corresponding action plans including decisions.
- Quality management of supplier qualification program including performance monitoring for key suppliers.
- Ensure metrics and KPIs are being met. Provide guidance and support for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.
- Represent affiliate QA in regional, global and cross functional teams, projects and programs, as assigned by management.
- Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
- 3+ years’ experience in quality assurance, quality oversight or relevant experience.
- Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
- Knowledge and familiarity with product, process, and both internal and external customer requirements.
- Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products preferred.
- Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
- Strong oral and written communication skills needed. Proficiency in English. Excellent interpersonal skills.
- Strong computer skills and knowledge of enterprise systems such as SolTraqs, Atttache and Attache Pro. Runs small project to deliver tactical results.
Travel: Yes, 5 % of the Time
Job Type: Experienced