QA Senior Specialist - External Quality, Strategy, Processes and Metrics

Role Summary

QA Senior Specialist - External Quality, Strategy, Processes and Metrics will maintain commercial product specifications across GMP systems, manage SAP workflows to ensure compliance with product dossiers, and enable timely release of products. The role includes lifecycle management of specifications, revisions based on health authority feedback during post-approval changes, and submissions to additional countries. It requires strong QA leadership, collaboration with internal sites and contract manufacturers, and oversight of change control processes.

Responsibilities

• Maintain commercial product specifications current in all GMP systems.
• Manage SAP workflow to ensure compliance to product dossiers and enable timely release of products.
• Lead lifecycle management of specifications, including revisions based on health authority feedback during post-approval changes and submissions to additional countries, or changes identified through continuous process verification.
• Manage change control records in GVault pertaining to specification revisions.
• Be well-versed in using the SAP system.
• Support responses to health authority inquiries related to specifications.

Qualifications

• Required: 7+ years of relevant experience in a GMP environment and a BS or BA.
• Required: 5+ years of relevant experience and a MS.
• Preferred: Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
• Preferred: Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) to ensure defined quality objectives are met.
• Preferred: Maintains programs and processes to ensure high quality products and compliance with current GMPs.
• Preferred: May participate in the writing of annual product reviews and development of training programs regarding all aspects of producing quality products.
• Preferred: May assist or lead compliance audits; may interface with regulatory agencies as required.
• Preferred: Interfaces with internal sites and contract manufacturers to address inquiries from health authorities during product submissions and post-approval changes.
• Preferred: Proficient in application of QA principles, concepts, industry practices, and standards.
• Preferred: Demonstrates ability to effectively manage multiple projects/priorities.
• Preferred: Has proven analytical and conceptual skills.
• Preferred: Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.
• Preferred: Demonstrates excellent verbal communication, technical writing and interpersonal skills.
• Preferred: Demonstrates working knowledge and good proficiency in Microsoft Office applications.
• Preferred: Knowledge of Six Sigma, DMAIC, performance measures and quality improvement statistical methods.
• Preferred: Working knowledge of Risk Management tools (e.g., HACCP and / or FMEA) is beneficial.
• Preferred: Knowledge with IND/NDA/BLA submission process is desired.

Education

• BS or BA in a related field required.
• MS degree with 5+ years of GMP experience is acceptable.

Skills

• Proficient in QA principles, concepts, industry practices, and standards.
• Excellent verbal communication, technical writing, and interpersonal skills.
• Working knowledge of Microsoft Office applications.
• Understanding of Six Sigma, DMAIC, performance measures, and quality improvement statistical methods (beneficial).
• Knowledge of risk management tools (HACCP and/or FMEA) is beneficial.
• Familiarity with IND/NDA/BLA submission processes is desired.