Job Summary

The Director of Quality Control is responsible for overseeing quality control operations at multiple manufacturing sites across the United States. This role ensures that all processes comply with effectiveness and efficiency standards. The Director will lead the US Quality Control team.

Key Responsibilities

• Assess and uphold the quality, integrity, and performance of products in US QC Chemical and Microbial operations.
• Ensure staff are trained in GxP manufacturing practices and follow safety protocols.
• Prepare QC site managers for audits and inspections.
• Oversee the development of laboratory investigations, out-of-specifications, deviations, and CAPAs.
• Manage the transfer of procedures and analytical methods to support GxP manufacturing.
• Facilitate communication between sites and key stakeholders in Operations, Quality Assurance, and plant management.
• Collaborate with management to set QC Chemical standards of operation.
• Manage the Quality Control budget to meet business objectives.
• Foster a culture of open communication and continuous improvement within the QC team.
• Conduct performance evaluations and mentor team members.
• Handle disciplinary actions in accordance with company policy.

Qualifications

• Bachelor’s degree in a scientific or engineering field; Master’s degree preferred.
• 8 to 10 years of relevant experience, with at least 5 years in a quality engineering role.
• Proficient in developing protocols, summary reports, and SOPs.
• In-depth knowledge of Quality Control standards, cGMP, CGLP, Data Integrity, and Risk Management.
• Familiar with manufacturing processes in the pharmaceutical industry.
• Exceptional verbal and written communication skills.
• Strong organizational skills and attention to detail.
• Proven ability to coach and mentor team members.
• Excellent analytical and problem-solving skills.
• Strong supervisory and leadership abilities.