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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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