Quality Manager

Position Summary:

The Quality Assurance Manager will lead the quality function, ensuring compliance with statutory and regulatory requirements, including ISO 13485, FDA 21 CFR 210/211 cGMP, and IPEC Excipient standards, across supply chain, production, and post-production processes. The role includes maintaining the Quality Management System (QMS), supervising QA staff, driving continuous improvement, and acting as the site’s quality representative for management and customer relations.

Key Responsibilities:

• Develop, implement, and maintain the Quality Management System.
• Provide leadership, supervision, and training to QA staff, delegating work appropriately.
• Oversee QA activities for existing and new products, including risk management, equipment qualification, process validation, and document approval.
• Review and approve:
  • Design and process evaluations (material/product specifications, test methods, risk analyses)
  • Facility qualification protocols and reports
  • Manufacturing batch sheets, cleaning forms, SOPs, lab reports, and other quality documentation
  • Problem investigations (OOS, Deviations, Complaints, NCs) and CAPAs
  • Change controls and document change requests
• Conduct and oversee quality audits (internal, customer, agency, third-party).
• Report department metrics, KPIs, and quality indicators to management.
• Participate in customer product reviews and quality agreements.
• Ensure adherence to company and ISO 14001/45001 safety standards.
• Drive continuous improvement initiatives using Lean tools in support of operational excellence programs.
• Serve as Management Representative for ISO 13485, ensuring QMS documentation, promoting regulatory awareness, and reporting effectiveness to top management.

Education & Experience:

• Master’s or Doctorate in Sciences, Regulatory Sciences, or Engineering; or Bachelor’s with minimum 5 years as QA Manager or Supervisor.
• Minimum 5–10 years’ experience in regulated chemical, pharmaceutical, or medical device manufacturing environments.
• Extensive knowledge of process, test, and equipment validation.
• Experience conducting quality audits and managing CAPA systems.

Skills & Abilities:

• Strong leadership, interpersonal, and communication skills; effective team player.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Familiarity with statistics tools (e.g., Minitab) desirable.
• Strong attention to detail, ability to meet deadlines, and work independently in fast-paced environments.
• Commitment to guiding principles such as integrity, optimism, diligence, stewardship, humility, and shared outcomes.