Job Description

JOB DESCRIPTION

Insight Global is seeking an experienced Quality Manager for our client, a key partner in the pharmaceutical sector, based in Easthampton, MA. This Quality Manager will oversee the QA and QC departments, as well as the entire quality management system (QMS) ensuring products meet customer specifications and are compliant with all applicable quality standards. Qualified candidates will have a strong background and understanding of ISO standards and FDA regulations. While this client is non-FDA regulated, their customers are. Day-to-day responsibilities include:

QUALITY RESPONSIBILITIES:

• · Responsible for being reviewer and signatory on all Customer Quality Agreements.
• · Manages all customer audits (onsite and virtual) including audit preparations, participating during day of audit, and audit response
• · Coordinates with management team to identify critical success factors, develops and maintains KPIs, and implements continuous improvement programs.
• · Maintains, enforces, and measures company Quality System.
• · Responsible for generating and performing (where applicable) processes and equipment validations.
• · Responsible for managing company Training Program, including setting up initial training packets, performing initial GDP training for new personnel and running annual GDP refresher training for company.
• · Responsible for Equipment Control program, including calibration schedules and validations as needed.
• · Responsible for managing Supplier Control program.
• · Responsible for managing/scheduling all QC product or facility testing performed by outside suppliers.
• · Manages final review and release of production batches.
• · Assists with special projects as required.
• · Performs other related duties as assigned by management.
• · Directly manages employees within the Quality Department, including Quality Associates, Shipping Department staff, Material Control Department staff and Purchasing.

REQUIRED SKILLS AND EXPERIENCE

- 4+ years of Quality Management experience in the pharmaceutical or medical device industry

- Experience with ISO-9001 standards

- Strong knowledge of pharmaceutical manufacturing processes, computer and equipment validation, GMPs, and product/process validation

- People-management experience

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