Supplier Quality Assurance Specialist

The Supplier Quality Assurance Specialist will evaluate, qualify and monitor the quality of external vendors providing Veranova materials, supplies and services impacting the quality of materials produced by Veranova.

Core Responsibilities: 

• Lead and perform supplier qualification activities including conducting audits, working with new and existing suppliers to help them understand Veranova’s quality requirements and close gaps in their quality systems or processes
• Drive supplier risk assessment evaluation, develop mitigation plans, and their execution for quality supply chain risks during commercialization phase in partnership with a cross-functional team
• Perform supplier-related activities such as: define performance metrics, complete/evaluate supplier score cards, monitor activities, continuous improvement, etc.
• Develop and maintain a robust supplier performance monitoring system, including tracking and analyzing supplier quality metrics (e.g., deviations, SCARs)
• Establish and manage key performance indicators (KPIs) to evaluate supplier performance and identify areas for improvement
• Use quantitative analysis to identify high-risk suppliers and develop strategies for mitigating risks in supplier quality systems
• Collaborate with suppliers and internal cross-functional teams on material problems to reduce and/or eliminate impact on the supply chain
• Act as the main point of contact for quality-related supplier issues and provide guidance and support to internal teams in resolving supplier-related quality challenges
• Initiate, monitor and drive to closure Supplier Corrective Action Requests (SCAR) and internal corrective actions
• Identify and drive implementation of supplier management continuous improvement changes in the quality-management system
• Assist with the completion of deviations, investigations, CAPAs and change controls as required
• Maintain supplier quality records in accordance with internal procedures to ensure documentation meets cGMP requirements
• Identify and escalate any potential compliance issues to the QMS Manager and Quality Director in a timely manner
• Communicate and collaborate effectively within the Quality division and with other departments
• Take on any other duties or projects which are within the employee’s skills and training whenever reasonably required to support Veranova quality objectives.

Qualifications: 

Required

• Bachelor’s degree in engineering, science or related field and/or industry training or certification(s) in Lean manufacturing methods/tools such as structured problem solving, Lean Six Sigma, etc.
• Minimum 5 years of supplier quality, engineering, or quality assurance experience, with a minimum 2 years supporting compliance to GMP, ISO, or international regulatory requirements
• Experience driving complex projects with the ability to initiate, prioritize, and successfully complete
• Experience performing internal, external or supplier audits
• Proven experience working effectively in team situations and as an individual contributor
• Strong knowledge of pharmaceutical industry standards, quality systems, and regulations.
• Excellent communication and interpersonal skills with the ability to manage cross-functional relationships.
• Analytical mindset with a strong attention to detail and problem-solving skills
• Professional working style with hands-on involvement with all phases of projects
• Demonstrated networking and influencing skills; ability to collaborate and influence effectively across a broad range of associates spanning varied disciplines and responsibilities

Preferred

• Certified Lead Auditor certificate and/or ASQ Supplier Quality Professional Certification (CSQP) desired