Quality Assurance Manager

Overview:

As the QA Manager, you will be responsible for developing, implementing, and maintaining a comprehensive Quality Management System and play will play a key role in fostering a culture of quality, efficiency, and continuous improvement at the facility.

Responsibilities:

• Develop, implement, and manage the site Quality Management System (QMS) that aligns with industry standards and organizational objectives.
• Facilitate quality and continuous improvement initiatives to enhance operational efficiency, customer satisfaction, and overall performance.
• Lead all quality efforts at the plant to ensure that our products consistently meet or exceed defined quality standards and customer expectations.
• Collaborate with cross-functional teams to identify and implement quality improvements, drive process optimization, and achieve cost-effectiveness.
• Ensure timely resolution and closure of Corrective and Preventive Action (CAPA) plans.
• Conduct regular audits and assessments to evaluate the effectiveness of the QMS and processes, identifying areas for improvement.
• Analyze quality performance data and metrics to identify trends, develop insights, and drive data-driven decision-making.
• Establish and monitor key performance indicators (KPIs) to track the effectiveness and efficiency of quality processes and continuous improvement initiatives.
• Ensure site adheres to local regulations and industry standards for pharmaceutical packaging and printing.
• Ensure timely and accurate reporting of safety concerns, incidents, and near misses.
• Oversee housekeeping walkthroughs and address all safety issues with Plant Management.
• Conduct monthly trainings and safety meetings to reinforce safe work practices and company policies.
• Oversee monthly 5S projects to improve workplace organization, cleanliness, and efficiency. Work with teams to ensure compliance with 5S principles.
• Provide training and mentorship to employees to enhance their understanding of quality principles, practices, and methodologies.
• Oversee supplier quality management, including supplier evaluations and audits, to ensure the quality of incoming materials and components.
• Represent the facility in dealings with external stakeholders related to quality and continuous improvement.
• Assist plant Management in driving a culture of quality excellence, continuous improvement, and accountability.
• This role will have supervisory responsibilities over the Quality Department, and it is expected that this individual will have previous experience leading successful teams.
• Other duties as assigned

Qualifications:

• Bachelor's degree in a related field (e.g., Quality Management, Engineering, Business Administration) is preferred.
• Minimum of 5 years of experience in quality management within the printing, packaging or pharmaceutical industries, with a proven track record of improving quality standards and processes.
• Expertise in ISO 9001 (Quality Management Systems) and ISO 15378 (Primary Packaging Materials for Medicinal Products) standards
• Expertise with FSC, SFI and PEFC environmental certifications and system maintenance
• Prior experience managing direct reports and leading teams to drive quality improvements and standardization efforts.
• Understanding of pharmaceutical industry regulations, including cGMP, FDA, and international quality standards.
• Strong analytical skills with the ability to analyze data, identify trends, and implement effective solutions.
• Excellent communication and interpersonal skills to lead and collaborate with cross-functional teams, direct reports, and stakeholders.
• Proficiency in quality management systems, data analysis tools, and software applications.
• QCBD Software Experience is a plus
• Relevant certifications such as Certified Quality Manager (CQM) or Certified Quality Auditor (CQA) are advantageous.
• Lean Six Sigma certification is a plus