The Director of Operations is responsible for the overall quality, regulatory, materials management and manufacturing functions of the assigned facility and leads the manufacturing and quality teams to produce cGMP compliant drug products, which meet customer, cost and lead-time expectations.
Leads the manufacturing and quality teams to meet customer cost and lead-time expectations while adhering to cGMP standards. The role also requires a continuous improvement mindset to deliver on cost and quality targets.
- Responsible for overall quality, regulatory, materials management, and manufacturing functions.
- Maintains corporate compliance with cGMP standards and maintains 503B regulatory status.
- Works cooperatively with all functional areas of the business to facilitate innovation while ensuring that the company delivers products and services of the highest quality in compliance with all applicable laws and regulations.
- Liaison with all relevant regulatory bodies including the FDA and State Boards of Pharmacy.
- Drives an effective CAPA program with regularly scheduled meetings.
- Works closely with the sales, marketing and operations teams to facilitate product registrations, field actions/recall management, product life cycle management and asset management in line with business objectives to drive business improvement and competitive advantage
- Delivers service levels and costs in-line with customer and company expectations, respectively.
- Management and development of individual team members.
- Prudent management of budgeted expenses.
- Ensures compliance with standard operating procedures, forms, training, and quality control activities.
- Leads several direct reports based on facility needs
EXPERIENCE AND NECESSARY SKILLS:
- Bachelor’s degree in engineering, science or related discipline. Master’s degree is preferred.
- Minimum 10 years in related Manufacturing QARA/Operations/Manufacturing position preferred. At least five years in a significant managerial role.
- Demonstrated knowledge of cGMP guidelines/standards is required.
- Comprehends standard operating procedures, forms, training, and quality control activities
- High integrity, good judgment, ability to work remotely from the corporate offices, in a matrixed environment.
- Excellent organizational skills.
- Team player and proven flexibility; high degree of motivation.
- Strong hands-on, “roll up your sleeves” orientation, with emphasis on achieving results
- Ability to think strategically and execute on strategy.
- Strong Microsoft Office skills are essential, as are experience in project and budget management.
- Excellent people management, analytical and problem solving skills.
- Demonstrated written and oral communications skills including strong presentation skills.