Supervisory Responsibilities

• Provides leadership to the Quality Assurance and Quality Control departments
• Oversees workflow of the Quality Control and Quality Assurance teams 
• Develops personnel to ensure functionality across teams, high performance, and talent retention 
• Integrates with the Senior Leadership Team to develop personnel and organizational effectiveness

Duties and Responsibilities

• Serve as the strategic leader to drive, direct, oversee and manage quality and compliance across all departments, and ensure that quality strategies are known and implemented
• Develop and implement a comprehensive Quality strategy to support the manufacturing, testing, and release of pharmaceutical products in accordance with GMP regulations and other relevant standards
• Identify Key Quality and Risk Indicators (KQIs/KRIs) and oversee mechanisms for detection and trending
• Oversee and manage all aspects of the Quality Management System (QMS) to ensure compliance with GMP and other applicable guidelines
• Provide strategic leadership to the Quality Assurance and Quality Control Departments, fostering a culture of excellence, accountability, and continuous improvement within the GMP framework
• Collaborate with cross-functional teams, including Product and Process Development, Manufacturing Operations, Facilities Engineering, Supply Chain and Environmental Health and Safety, to ensure seamless integration of quality processes throughout the product life cycle in alignment with GMP requirements
• Conduct risk assessments and implement proactive measures to prevent and address quality issues, deviations, and non-conformances within the GMP context
• Lead and support regulatory inspections, ensuring readiness and effective responses to inspection findings, with a focus on GXP compliance
• Establish and maintain key performance indicators (KPIs) to monitor and report on the effectiveness of the Quality Assurance program within the GXP framework
• Drive the development and execution of training programs to enhance the skills and knowledge of quality personnel and other relevant stakeholders, with emphasis on GXP principles
• Develop and implement Quality organizational goals aligned with the company’s vision
• Develop and administer budgets, plans, and performance requirements linked to the quality Assurance and Quality Control departments
• Other related duties as assigned

Required Knowledge and Skills

• Strong leadership and management skills
• In-depth knowledge of FDA regulations, GMP guidelines, and other relevant quality standards
• Proven leadership experience with a track record of successfully managing and developing high-performing teams within a GMP environment
• Demonstrated success in regulatory inspections and interactions, specifically within the GMP framework
• Excellent verbal and written communication skills
• Excellent interpersonal and customer service skills 
• Excellent sales and customer service skills
• Excellent organizational skills and attention to detail 
• Excellent time management skills with a proven ability to meet deadlines
• Excellent analytical and problem-solving skills with the ability to make informed decisions in complex situations, taking GMP regulations into account
• 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

Education and Experience

• Bachelor’s or advanced degree in scientific discipline
• Minimum of 15 years of progressive experience in Quality Assurance and/or Quality Control in a pharmaceutical manufacturing environment
• Previous experience developing, implementing, and monitoring Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines
• Requires 10 years of GMP expertise

Physical Requirements

• Prolonged periods of sitting or standing at a desk and working on a computer
• Must be able to lift up to 15 pounds at times
• National and International travel required
• Adheres to predictable and in-person attendance