Reporting to the Director, Quality & OPEX the Quality Manager will lead the deployment of quality assurance principles, structure and processes for an assigned area of our Manufacturing operations. He/she will be responsible for the implementation of product quality requirements in accordance with customer and company requirements, leading and developing Associates and supporting Operational Excellence. 

The Quality Manager will play an instrumental role in governing quality programs at our client to ensure the integrity of quality related to all manufactured processes and products, incoming materials through inspection, testing & control approvals; quality records review, conducting regular product audits, quality improvement, training, RCA/CAPA investigation of quality issues, deviations, and non-conformances. 

 Key Accountabilities:

• Develop a QA mindset across the team; identify & provides necessary training, coaching, performance evaluation, support and assistance; provides technical and functional guidance; delegates tasks to direct reports.
• Prepares regular quality reports and tracks quality KPIs in assigned area; facilitates regular reviews of quality issues with stakeholders; coordinates necessary quality improvement initiatives
• Oversees release of FG products; ensures that production records are complete, accurate and in compliance; 
• Support Quality Management Systems, including harmonization/integration of management systems (Quality, Environmental and Health & Safety)
• Liaise with clients as needed to resolve problems, align on standards and improve the customer experience
• Facilitates root cause analysis & CAPA investigation for any quality issues; provides leadership and vision in the use of data along with structured problem-solving framework 
• Support and participate in the deployment of the local Quality and Operational Excellence strategy to accelerate the rate of operational improvement
• Oversee Quality Training Program of direct and indirect reports and provides necessary quality-related training to other stakeholders 
• Support /Assist in any other quality-related activities; leads/facilitates quality improvement teams & initiatives 
• Assists in preparation, handling & hosting regulatory or customer audits with Quality Compliance team

Skills, Experience and Education Required:

• BS or BA Degree in Engineering or related field
• Minimum 4+ years functional experience in quality control and product quality assurance, product audits, quality control principles; training experience with knowledge of GMP regulations; validation, process control and quality improvement
• Minimum of 3 years people management experience (coaching/mentoring) in quality assurance and quality functions
• Excellent technical acumen & troubleshooting skills; creative ability and strong hands-on skills in problem solving and root cause analysis
• Excellent communication and technical writing skills necessary to effectively discuss quality expectations with internal and external customers; customer-focused and able to work with all levels of technical staff, customers, and manufacturing staff 
• Self-motivated with the ability to set objectives and meet customer expectations on multiple projects; highly organized with the ability to work in a fast-paced environment