Job Title: Manufacturing Quality Manager
Department: Quality Assurance
Reports To: Sr. Director of Quality
Effective Date: 09/02/2025
Salary Range: $90,000 – $120,000 (Salaried)
Direct Reports: QA Specialists, QA Technicians

Job Summary: The Manufacturing Quality Manager is responsible for the quality oversight of all manufacturing and packaging operations to ensure compliance with applicable regulations (21 CFR Part 210/211), internal quality standards, and customer expectations. This role is central to implementing and maintaining a compliant manufacturing environment in a fast-paced, plant-based setting, with a focus on continuous improvement, operational efficiency, and regulatory excellence.

Key Responsibilities:

• Provide quality oversight for all pharmaceutical manufacturing and packaging operations on-site.
• Supervise and lead QA staff responsible for line release, batch record review, and process validation activities.
• Manage incoming inspection and sampling of raw materials and packaging components.
• Own the SOP lifecycle, including review, approval, and biennial updates.
• Participate in the investigation and resolution of product quality issues and non-conformances.
• Oversee the issuance and approval of batch records, labels, specifications, and monographs.
• Manage product quarantine shipments, recall programs, and the pest control program.
• Audit internal manufacturing processes to ensure compliance and readiness for regulatory inspections.
• Oversee facility environmental monitoring, including temperature and humidity controls.
• Support the product stability program and provide quality support to cross-functional teams.
• Collaborate with the Senior Director of Quality on strategic initiatives and compliance goals.

Required Skills and Competencies:

• Strong leadership and team management capabilities, with experience leading QA personnel in a manufacturing environment.
• Deep understanding of cGMPs, particularly in OTC or pharmaceutical manufacturing.
• Excellent communication skills, both written and verbal.
• Highly organized, with strong attention to detail and the ability to manage multiple priorities under pressure.
• Proven ability to analyze data, manage quality systems (change control, deviations, CAPAs), and implement improvements.
• Experience conducting internal audits and supporting regulatory inspections.

Education and Experience Requirements:

• Bachelor’s degree in Chemistry, Biology, or a related scientific discipline (required).
• Minimum of 8 years’ experience in pharmaceutical or OTC manufacturing environments.
• Prior experience with liquid and solid oral dosage forms required.
• People management experience is required; must have led QA teams or operations personnel.
• Strong familiarity with FDA regulations and 21 CFR Part 210/211.
• Proficient in Microsoft Office and quality management systems (QMS platforms a plus).

Physical Requirements:

• Ability to walk, stand, and sit for 8 or more hours daily.
• Must be comfortable working in plant and production environments.

Ideal Background:

• Prior experience in an OTC manufacturing facility is preferred.
• Candidates from aseptic or more highly regulated pharmaceutical environments are welcome, provided they can adapt to a broader manufacturing scope.
• This role is not clinical in nature – GCP or clinical QA backgrounds are not aligned with the position's responsibilities.

Screening Questions (Optional for Application):

• Do you have 8+ years of experience in the industry, including overseeing manufacturing and packaging operations in a pharmaceutical or OTC environment?

What specific dosage forms (e.g., liquid, solid oral) have you worked with?

• What is your experience with change control, deviations, CAPAs, and SOPs?

Have you led or contributed to any continuous improvement initiatives involving these systems?

• Have you directly managed QA staff?

How many people did you manage, and what were their roles/titles?

• What is your highest level of completed education?
• Have you worked in a plant-based or OTC manufacturing environment?

If from a highly regulated background, how do you adapt to broader manufacturing scopes?

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