Manufacturing Quality Manager

Position Overview
The Manufacturing Quality Manager is responsible for overseeing quality assurance within manufacturing and packaging operations to ensure compliance with regulatory requirements, internal standards, and customer expectations. This role plays a key part in maintaining a compliant, efficient, and continuously improving production environment, with an emphasis on operational excellence and regulatory readiness.

Key Responsibilities

• Provide quality oversight for all on-site manufacturing and packaging activities.
• Lead and supervise QA personnel responsible for line release, batch record review, and validation support.

• Manage inspection and testing of raw materials and packaging components.

• Oversee the lifecycle of standard operating procedures (SOPs), including review, approval, and updates.
• Support investigations and resolution of product quality issues and deviations.

• Approve batch records, specifications, and related documentation.

• Oversee product disposition, recall activities, and pest control programs.

• Conduct internal audits to ensure compliance and inspection readiness.

• Manage environmental monitoring of facilities and equipment.

• Support product stability studies and cross-functional quality initiatives.

• Partner with senior quality leadership on compliance and process improvement strategies.

Qualifications

• Bachelors degree in Chemistry, Biology, or a related scientific field.

• At least 8 years of quality assurance experience in a regulated manufacturing environment.

• Experience with multiple dosage forms, including liquids and solids.

• Proven leadership experience managing QA teams or quality staff.

• Strong knowledge of cGMPs and applicable regulatory requirements.

• Skilled in quality systems, including change control, deviations, and CAPA.

• Experience with audits and regulatory inspections.

• Proficiency with Microsoft Office and quality management systems.

Additional Requirements

• Strong organizational and communication skills.

• Ability to manage multiple priorities under time-sensitive conditions.

• Comfortable working in plant and production environments, with the ability to stand, walk, and sit for extended periods.