Quality Control Manager- Pharmaceutical

Job Summary

We are seeking a dynamic and detail-oriented Quality Control Manager to lead our pharmaceutical quality control operations. In this pivotal role, you will oversee the implementation and maintenance of robust quality systems, ensuring our products meet the highest standards of safety, efficacy, and compliance. Your expertise will drive continuous improvement initiatives, uphold regulatory adherence, and foster a culture of quality excellence across manufacturing processes. This is an exciting opportunity to influence product integrity and contribute to the well-being of consumers worldwide.

Responsibilities

• Develop, implement, and maintain comprehensive quality control and assurance programs aligned with industry standards such as ISO 13485, ISO 9001, FDA regulations, HACCP, CGMP, and other relevant frameworks.
• Lead quality audits across manufacturing facilities to verify compliance with regulatory requirements and internal standards.
• Oversee quality inspection processes to ensure raw materials, in-process products, and finished goods meet specified quality criteria.
• Manage non-conformance investigations, root cause analysis, and corrective/preventive actions to resolve quality issues promptly.
• Collaborate with cross-functional teams on new product development projects to integrate quality management principles from inception through production.
• Conduct training sessions for staff on quality systems, regulatory updates, and best practices in pharmaceutical manufacturing.
• Prepare detailed reports on quality metrics, audit findings, and compliance status for senior management review.

Requirements

• Proven experience in pharmaceutical manufacturing or related industries with a strong understanding of quality control and assurance processes.
• In-depth knowledge of ISO 13485 (medical devices), FDA regulations (21 CFR Part 210/211), HACCP principles, CGMP guidelines, and ISO 9001 standards.
• Demonstrated ability to conduct thorough quality audits and inspections within regulated environments.
• Strong analytical skills for data analysis, trend identification, and problem-solving related to product quality issues.
• Excellent project management skills with the ability to lead multiple initiatives simultaneously while maintaining attention to detail.
• Effective communication skills for training teams and liaising with regulatory authorities.
• Relevant certifications such as CQE (Certified Quality Engineer), Lead Auditor certifications are preferred.

Join us in ensuring the highest standards of pharmaceutical products! Your expertise will help safeguard consumer health while advancing your career in a fast-paced, innovative environment committed to excellence in quality management.

Pay: $70,000.00 - $90,000.00 per year

Benefits:

• Health insurance
• Paid time off
• Relocation assistance

Work Location: In person

Salary : $70,000 - $90,000