Quality Assurance Supervisor

We are seeking an experienced Quality Assurance Supervisor to provide leadership and oversight of quality systems within a regulated GMP manufacturing environment. This role is responsible for ensuring compliance, supporting continuous improvement, and maintaining high standards across manufacturing, packaging, laboratory, and quality operations.

The ideal candidate is a hands‑on quality professional with strong knowledge of cGMP regulations, investigations, validation, audits, CAPA, documentation, and quality systems, along with the leadership skills needed to partner effectively with Operations and Senior Management.

• Provide leadership and oversight of key Quality Assurance programs, including GMP compliance, labeling, training, document control, information tracking, equipment calibration, and quality metrics
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• Monitor the site’s overall compliance profile and drive continuous improvement initiatives, Quality Review Board (QRB) activities, and quality performance metrics
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• Review and approve qualification and validation protocols, reports, and related documentation
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• Utilize statistical process control and quality data to identify trends, risks, and opportunities for improvement.
• Prepare and present KPI and quality trend reports to Senior Management.
• Review and approve Manufacturing, Packaging, and Quality Operations processes and GMP documentation
  .
• Review and approve Master Labels and Certificates of Analysis (C of
  
  A) for finished products.
• Assist with the development, revision, implementation, and approval of SOPs and controlled documents
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• Review and approve change controls
  , ensuring appropriate assessment of quality and regulatory impact.
• Develop, strengthen, and maintain quality subsystems, including:
• CAPA (Corrective and Preventive Action)
• Deviation and investigation programs
• Customer complaints
• Document and change control
• Lead or support quality investigations
  , including root-cause analysis, risk assessment, and development of effective corrective and preventive actions.
• Support Senior Management during FDA, DEA, customer, and other regulatory inspections and audits
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• Assist in establishing and maintaining raw material and finished product specifications based on regulatory requirements, product standards, and customer expectations.
• Support preparation and completion of Annual Product Reviews (APR).
• Partner with Manufacturing, Operations, Regulatory, and other departments to promote a strong quality culture and right-first-time mindset
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• Ensure compliance with applicable cGMP regulations, company policies, SOPs, and regulatory requirements
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• Promote employee awareness, accountability, and continuous improvement throughout the organization.
• Perform other quality-related duties and projects as assigned.

• Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or another related scientific discipline preferred.
• 6+ years of Quality Assurance experience within a GMP-regulated manufacturing environment.
• Experience providing leadership, supervision, mentoring, or management within a Quality function.
• Strong working knowledge of cGMP requirements and FDA regulations
  , including 21 CFR Parts 11, 111, 210, and 211
  .
• Solid experience with quality systems, investigations, CAPA, change controls, validation, audits, and regulatory compliance
  .
• Strong understanding of quality risk management and audit principles within a regulated manufacturing environment.
• Ability to read, interpret, and apply technical procedures, SOPs, GMP requirements, and governmental regulations
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• Strong analytical and problem‑solving skills, including experience with root‑cause analysis and quality trend evaluation
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• Excellent written and verbal communication skills with the ability to effectively communicate quality requirements to all levels of the organization.
• Demonstrated ability to lead, motivate, coach, and develop employees while effectively resolving conflicts and driving accountability.
• Strong attention to detail with the ability to manage multiple priorities in a fast‑paced manufacturing environment.
• Solid dose manufacturing and quality compliance experience strongly preferred.
• Experience with FDA/DEA inspections and customer audits preferred.
• ASQ certification, ISO 9000/ISO 9001 experience, or formal auditor training preferred.

The successful candidate will be a visible and collaborative Quality leader who can balance regulatory compliance with business needs, identify potential quality risks before they become problems, and work closely with Operations to continuously improve processes, systems, and overall site performance.