Associate Director, Quality Control

Job Description

The Quality Control department seeks an industry leader who demonstrates strong regulatory knowledge and GMP standards to oversee the Stability and Release program as Associate Director within the department. The Associate Director of Quality Control will be responsible for improving, developing, implementing, and maintaining release and stability programs, and overall GMP compliance. Also, ensuring that all aspects of the quality control system are effectively established, implemented, and maintained in accordance with US-FDA, EU and other applicable regulations. Successful candidates will demonstrate experience in a supervisory role with dedication to fostering employee training, education, and a culture of safety and compliance within a Quality organization.

Supervisory Responsibilities

• Recruits, interviews, hires, and trains new staff
• Oversees daily workflow of the department or direct reports
• Provides constructive and timely performance evaluations
• Handles discipline and termination of employee in accordance with company policy
• Performs other related duties as assigned

Duties and Responsibilities

• Ensures that QC Systems and practices are developed and implemented in accordance with the requirements of GMP
• Represents the site in client interactions for all questions related to release and stability testing
• Represents the site in audits and inspections related to release and stability chemistry testing
• Supervises release and stability teams, acting as an advisor to team members when determining how to meet schedules or resolve technical problems
• Reviews testing and laboratory records for accuracy and compliance with cGMP and company policies and procedures
• Develops stability program and policies, ensuring sampling plans are up to date and executed as planned
• Hosts monthly trend meetings, sharing trend information with the site Quality Council, and identifying and escalating adverse trends
• Drives corrective and preventative actions, ensuring work is complete and the site remains in a state of control and compliance
• Leads QC Chemistry investigations
• Monitors QC resource capacity and providing feedback to QC management, program management, and production planners when capacity constraints exist
• Responsible for building and improving quality systems
• Control and execution of Deviations
• Corrective/Preventive Action (CAPA) plans
• Out-of-Specification/Out-of-Trend (OOS/OOT) results
• Updates management on activities as well as provide input and recommendations as appropriate
• Preparation and support for internal audits

Required Skills and Abilities

• Comprehensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development with prior experience through commercialization
• Proven experience developing budgets, monitoring, and escalating variances
• Experience and/or knowledge of stability requirements for non-sterile and sterile products
• Excellent knowledge of FDA/EU/ICH/CDN/AUS guidelines and inspections
• Maintain current knowledge of new technologies and potential applications
• Practical knowledge and understanding of implementing phase appropriate procedures and processes
• Excellent verbal and written communication skills
• Excellent interpersonal and customer service skills
• Excellent organizational skills and attention to detail
• Excellent time management skills with a proven ability to meet deadlines
• Strong analytical and problem-solving skills
• Demonstrate integrity towards testing and reporting
• Strong supervisory and leadership skills
• Ability to prioritize tasks and to delegate them when appropriate
• Ability to function well in a high-paced and at times stressful environment
• Proficient with Microsoft Office Suite or related software
• Proficient with Empower
• Proficient with Labware LIMS or similar (preferred)

Education and Experience

• BS in related scientific field, or equivalent work experience
• Thorough knowledge of GMP, SOPs and quality control processes
• Minimum of 5+ years of experience in a supervisory or management position
• Minimum of 5+ years of experience in stability program management (preferred)
• Minimum of 5+ years of GMP experience
• Minimum of 8+ years of Quality Control Chemistry experience for non-sterile formulations, such as dissolution and chromatography

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Prolonged periods of sitting or standing in laboratory environment
• Must be able to lift up to 15 pounds at times
• Motor skills required for basic laboratory operations (pouring liquids, using utensils to transfer powders, visual assessments)