Quality Assurance Manager

The Quality Assurance Manager is responsible for managing day-to-day QA operations activities in compliance to the ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. The Quality Assurance Manager is also the line manager for QA operations staff.

Key Job Responsibilities

• Direct the trend analysis data collection for quality system review.
• Act as lead auditor during vendor/internal quality audits to ensure that cGMP compliance is at the required standard for API manufacture, in accordance with ICH Q7a Guidance and FDA 21 CFR requirements. In addition, this position is responsible for managing the vendor assurance program.
• Support validation activities by providing input on the review and approval of validation protocols/reports and ensure that these documents/records comply with FDA validation guidelines and Avecia's validation master plan.
• Manage the review of quality records leading to the release of API in accordance with project timelines and ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
• Provide cGMP training to site staff and new hires as needed.
• Reviewing and approving deviations and gathering/compiling quality metric reports.
• Manage the Corrective and Preventative Action program. This may include chairing the Material Review Board and conducting QA investigations in accordance with the internal procedures.
• Conduct I participate in customer complaint investigations, as needed, and follow up with customers on all technical complaints until closure/resolution is reached.
• Provide assistance during cGMP compliance inspections of the Milford facility. This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections.
• Manage, develop and oversee the Quality Assurance Associates and QA Lead associates.
• Act as QA project representative on Avecia manufacturing campaigns as assigned.

Job Knowledge Required

• BS/BA in science or equivalent work experience with 5 years experience in a FDA­ regulated industry and a minimum of 2 years supervisory or managerial experience.
• Ability to provide expert advice and sound decision-making on all aspects of cGMP.
• Strong knowledge of the cGMP regulation and technical knowledge of the subject and the potential issues involved. This is achieved through a combination of experience in Quality Systems coupled with education and training in Quality Systems, cGMP, Quality audits, documentation, change control, corrective and preventative action, validation, calibration, review of quality records, quality metrics, failure investigations and manufacturing and laboratory controls as per cGMPs. As the regulatory and cGMP requirements frequently change, the jobholder must also maintain current knowledge.