Director of Commercial Quality Assurance

About the role

The Director of Commercial Quality Assurance is responsible for ensuring high-quality standards across all commercial manufacturing processes. This role oversees quality assurance initiatives, collaborates with cross-functional teams, and ensures compliance with regulatory requirements.

Responsibilities

• Oversee and manage quality assurance programs to ensure compliance with FDA and other regulatory standards.
• Develop and implement quality control procedures to monitor product quality throughout the manufacturing process.
• Collaborate with cross-functional teams to identify and mitigate risks, improve processes, and enhance product quality.
• Conduct regular audits and inspections to ensure adherence to quality standards.
• Provide guidance and support to team members on quality assurance protocols and best practices.
• Stay updated on industry trends and regulatory changes to inform quality assurance strategies.

Requirements

• Bachelor’s degree in a relevant field (e.g., Quality Assurance, Engineering, or Life Sciences).
• Minimum 10 years of experience in quality assurance within the pharmaceutical industry, with a focus on oral solid dosage products.
• Proven track record of successful implementation of quality assurance programs.
• Strong leadership skills and ability to manage a team.
• Experience with regulatory compliance and documentation.
• Excellent communication and interpersonal skills.

Qualifications

• Knowledge of cGMP regulations and industry best practices.
• Experience with quality management systems (e.g., ISO 9001, GAMP5).
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite.

Skills

• Strong analytical and problem-solving skills.
• Effective communication and presentation skills.
• Ability to prioritize tasks and manage multiple projects simultaneously.
• Experience with data analysis tools (e.g., Excel, SQL).

Benefits

• Competitive salary package.
• Flexible working hours.
• Health insurance coverage.
• Employee wellness programs.
• Professional development opportunities.

Pay

Salary range: $120,000 - $150,000 annually.

Schedule

Full-time, Monday through Friday, 8:00 AM - 5:00 PM.