QA Manager

Lexitas • Erie, PA

3d

About The Position

The QA Manager ensures consistent quality standards, compliance and continuous improvement as well as provides hands-on support to ensure the site meets regulatory requirements, customer expectations and organizational goals.

Requirements

• Required: Bachelor’s degree Engineering, Lifesciences or related discipline.
• 8+ years of relevant life science industry experience, with a minimum of 5 years of GCP compliance in an FDA regulated environment. Strong knowledge of regulatory and industry quality standards. Previous experience hosting regulatory inspections and customer audits.
• Strong ability to motivate company personnel to adhere to quality policies and procedures.
• Solid independent thinking ability and demonstrated ability to discern multiple viewpoints.
• Good working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations.
• Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs)
• Good analytical skills with the ability to evaluate data trends for lessons learned, required action, etc.
• Demonstrated ability to conduct root cause analysis and to prepare written remediation plans.
• Demonstrate process auditing and improvement skills and aptitude.
• Demonstrate ability to develop effective procedures and to write clear, consistent, thorough SOP’s.
• Excellent verbal and written communication skills.

Nice To Haves

• Preferred certifications: Quality Auditor

Responsibilities

• Establish and maintain QA policies, procedures and SOPs.
• Lead quality review meetings, ensuring alignment on metrics, issues and improvement plans.
• Ensure site compliance with relevant regulatory requirements.
• Lead internal and external audits across the site network.
• Maintain readiness for regulatory inspections, support site-level inspection teams and be QA Lead for regulatory inspections.
• Oversee CAPA, deviations management, change control and document control process at the site.
• Monitor and analyze quality metrics across the network to identify trends and areas of risk.
• Support root-cause analysis and problem-solving activities.
• Lead or support quality improvement projects, ensuring consistency in tools, methods and documentation.
• Facilitate training programs on quality principles, processes and compliance expectations.
• Identify and assess quality risks across the site network and develop risk mitigation strategies.
• Maintain network-wide risk registers and ensure proactive follow up on mitigation activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager