Quality Systems Specialist

Position Summary

Under the direction of the Director/Manager of Quality Systems, the Quality Systems Specialist manages various elements of the Quality Systems, including Change Controls, Quality Events, Deviations, Corrective and Preventative Actions, QMR, and Risk Management. This role involves close collaboration with cross-functional teams both on-site and abroad. The specialist will routinely report on quality system and business process performance, proactively identifying and implementing process and system improvements to resolve complex issues. As a member of the Site Investigation Team (SIT), this individual will investigate quality events and perform Root Cause Analysis (RCA).

Job Responsibilities

Financial (5% of time)

• Support resource planning and allocation within approved budgets.
• Build best-in-class quality processes and systems at the site.

Operational Excellence (50% of time)

• Investigate quality events using root cause analysis tools and maintain timelines for closure.
• Complete and maintain certified investigator training requirements.
• Coordinate with cross-functional teams for testing reserve or retain samples for investigations.
• Review relevant records (e.g., batch records, quality control data).
• Conduct root cause analysis to facilitate corrective and preventative actions.
• Participate in continuous improvement initiatives for investigations.
• Work with the CIT team for major and critical investigations.
• Track quality system metrics and create detailed trend analysis reports.
• Ensure Quality Systems comply with CGMPs and internal/external regulations.
• Evaluate and assist in implementing new changes for the site.
• Support projects that improve site quality and efficiency.
• Assess changes using Risk Management tools.
• Prepare and compile data to support APR submission for products manufactured on-site.
• Collect and prepare QMR board presentations and associated documentation.

Stakeholder Management (35% of time)

• Ensure Quality Systems comply with CGMPs and internal/external regulations.
• Provide guidance and work with stakeholders from various departments on Investigations, CAPA, Change Controls, and Deviations.
• Coordinate and collect information for QMR and annual product reviews.

Innovation (10% of time)

• Establish, revise, review, and continuously improve procedures for all Quality Systems.
• Establish Key Performance Indicators (KPIs) for the functional area and ensure systems operate within target.

Knowledge, Skills, and Abilities

Education

• Bachelor of Science (BS) or Bachelor of Arts (BA) in Science, Engineering, Pharmaceutical Sciences, or equivalent.

Experience

• Minimum of 3 years in Quality Assurance in the pharmaceutical, biopharmaceutical, or medical device industry, or a combination of education and experience.

Knowledge and Skills

• Strong understanding of current GMPs and related regulatory health authority guidance (FDA regulations, ICH guidelines).
• Proactive, results-oriented with strong attention to detail and time management skills.
• Ability to manage multiple projects simultaneously in a fast-paced environment.
• Excellent verbal and written communication skills.
• Strong interpersonal skills to interact professionally with all levels of personnel.
• Intermediate Excel and/or Minitab skills, including spreadsheet manipulation, charting, and analysis tools.

Leadership/Managerial Attributes

• Ability to work independently or within a team structure.
• Self-starter with the ability to work with minimal supervision and use good judgment.

Other Requirements

• Any quality or lean/Six Sigma certifications are a plus.