Job Description
Salary: $80,000 - 100,000/year We are seeking an experienced and detail-oriented Quality Manager to oversee and ensure the quality assurance processes in our pharmaceutical manufacturing operations. This role is critical to maintaining compliance with industry regulations, improving quality standards, and ensuring that our products meet or exceed customer and regulatory requirements.
The ideal candidate will have a strong background in pharmaceutical manufacturing, quality systems, and regulatory standards such as GMP (Good Manufacturing Practices) and FDA guidelines. They should be a proactive leader, able to manage a team and drive continuous improvements within the quality function.
Responsibilities - Lead, manage, and oversee the day-to-day operations of the Quality Assurance and Quality Control teams.
- Develop, implement, and maintain the Quality Management System (QMS) to ensure compliance with regulatory requirements, including FDA, EMA, ICH, and other applicable standards.
- Ensure compliance with GMP guidelines and maintain adherence to internal and external auditing processes.
- Review and approve batch records, specifications, and test protocols to ensure product quality standards are met.
- Conduct investigations and root-cause analysis of quality issues, deviations, and customer complaints; implement corrective and preventive actions (CAPAs).
- Collaborate with cross-functional teams (production, R&D, regulatory affairs, etc.) to develop and maintain product quality plans.
- Oversee the validation and qualification of manufacturing processes and equipment.
- Perform regular internal audits and inspections, and coordinate external audits with regulatory agencies and customers.
- Maintain up-to-date knowledge of regulatory changes and trends in the pharmaceutical industry to ensure the company remains compliant.
- Develop and execute training programs for employees in quality standards, procedures, and best practices.
- Monitor and track key quality performance indicators (KPIs) to identify areas for continuous improvement.
- Manage the preparation and submission of regulatory documents related to quality and manufacturing processes.
Requirements - Bachelor's degree in Pharmaceutical Sciences, Chemistry, Engineering, or a related field (Master's preferred).
- Minimum of 5 years of experience in quality management within the pharmaceutical manufacturing industry.
- In-depth knowledge of GMP, FDA, EMA, ICH regulations, and other global pharmaceutical standards.
- Strong leadership and team management skills, with experience in managing and developing quality assurance teams.
- Experience with quality control, process validation, and regulatory audits.
- Proficiency in using quality management software and systems.
- Excellent analytical and problem-solving skills, with a strong attention to detail.
$80,000 - $100,000 a year
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