Job Profile Summary The Quality Control (QC) and Quality Assurance (QA) Manager assists the QC QA Director with all aspects of quality management to ensure products and processes meet regulatory requirements, industry standards, and customer expectations. This role focuses on managing the QA / QC teams, provides plant technical support and driving continuous improvement in the quality team. Office will be based in Indianapolis, IN.
Job Description :
The Quality Control (QC) and Quality Assurance (QA) Manager assists the QC QA Director with all aspects of quality management to ensure products and processes meet regulatory requirements, industry standards, and customer expectations. This role focuses on managing the QA / QC teams, provides plant technical support and driving continuous improvement in the quality team. Office will be based in Indianapolis, IN.
- Assist in development and implementation of the QA policies, procedures and systems
- Ensure compliance with applicable regulatory standards (e.g., ISO, FDA, GMP, or other relevant certifications)
- Oversee quality audits and certifications to maintain compliance with industry and customer requirements
- Monitor Key Performance Indicators (KPIs) to measure quality performance
- Supervise QC operations, including testing, inspections, and documentation
- Ensure that raw materials, in-process products, and final products meet established quality specifications
- Assist in the development of quality control methods, equipment, and standard operating procedures (SOPs)
- Investigate and resolve quality issues, including non-conformance reports (NCRs) and corrective action plans (CAPAs)
- Drive initiatives to improve quality processes, reduce defects, and enhance product reliability
- Collaborate with cross-functional teams (e.g., operations, R&D, and supply chain) to identify and implement process improvements
- Stay updated on industry trends and technologies to maintain competitive quality standards
- Mentor the QA / QC teams, fostering a culture of accountability and excellence
- Provide training and resources to ensure team members are skilled in quality practices and tools
- Conduct root cause analyses to address quality issues and implement preventive measures
- Develop risk management strategies to mitigate quality-related issues
- Participate in quality-related matters during customer and regulatory audits
- Additional duties and responsibilities as assigned, including but not limited to continuously growing in alignment with the Company's core values, competencies, and skills.
Education Qualifications
Bachelor's degree in quality management, chemistry or a related field or 10-15 years equivalent experience is requiredExperience Qualifications
5+ years of experience in quality assurance, quality control, or related fields3+ years of leadership experience in quality management within manufacturing, pharmaceuticals, or a similar industryProven track record in managing quality systems, audits, and regulatory complianceSkills and Abilities
In-depth knowledge of quality management systems (QMS) and regulatory standards (e.g., ISO 9001, GMP, Six Sigma)Proficiency in quality tools and techniques (e.g., SPC, FMEA, CAPA, root cause analysis)Strong analytical and problem-solving skills with attention to detailExcellent leadership, communication, and interpersonal skillsProficiency in quality management software and toolsStrategic thinking to align quality initiatives with organizational goalsCommitment to maintaining high standards of quality and safetyStrong ability to manage multiple projects and meet deadlinesCollaborative approach to working with internal teams and external stakeholdersA proactive and hands-on approach to quality managementAbility to inspire and lead teams toward continuous improvement and excellenceStrong ethical standards and commitment to complianceDedication to fostering a culture of quality and accountability throughout the organizationAbility to travel 30-40%, fluctuates depending upon seasonality of the businessLicenses and Certifications
Valid driver's license is requiredWorking Conditions / Physical Demands
Ability to pass a drug test