Senior Director of Quality Operations and Technology - Remote

Overview

The Senior Director of Quality Operations and Technology will ensure the company goals are met for product quality, cGMP analytical and microbiological testing as they relate to finished goods, excipients, components and Environmental Monitoring.

In Short

• Ensure compliance with US Food, Drug & Cosmetic Act, Section 503B, and all cGMP elements.
• Responsible for all QC activities related to raw materials and finished products.
• Maintain quality systems including change control and CAPA.
• Manage external testing laboratories and ensure timely investigations.
• Oversee operations of in-house microbiology and analytical labs.
• Support the site Stability program for testing and data analysis.
• Develop and monitor KPIs to improve department metrics.
• Participate in internal and external audits.
• Manage heavy workloads and aggressive timelines.
• Provide input on employee development and performance feedback.

Requirements

• Bachelors Degree in Science, Microbiology, Engineering or related field required.
• 15 years of progressive experience within cGMP quality operations.
• Minimum of 10 years experience in Analytical Chemistry and Microbiology.
• Comprehensive knowledge of pharmaceutical quality systems and cGMP.
• Strong written, verbal, and presentation communication skills.
• Ability to work under pressure and meet deadlines.
• Familiarity with pharmaceutical manufacturing process operations.
• Strong computer skills in database management.
• Ability to complete tasks with little direction.
• Must be precise in laboratory data interpretations.

Benefits

• Opportunity to work in a leading pharmaceutical company.
• Engaging company culture and values.
• Potential for remote work flexibility.
• Support for professional development and growth.
• Involvement in significant projects within the pharmaceutical industry.
• Collaboration with a high-performing team.
• Comprehensive benefits package.
• Commitment to patient access to affordable medicines.
• Participation in mission work providing free medicines.
• Access to cutting-edge pharmaceutical technologies.