Quality Manager

Position Summary: The Quality Manager is responsible for maintaining and continuously improving the site's Quality Management System (QMS) to ensure all OTC drug products, including enema products, are manufactured, tested, packaged, and released in compliance with FDA cGMP requirements (21 CFR 210/211), applicable OTC monograph requirements, and internal quality standards. This role owns batch record review and product release, deviation/CAPA/complaint systems, internal and supplier audits, and serves as a primary quality contact during FDA inspections and customer audits.

Essential Duties and Responsibilities: Review and approve executed batch production records, in-process test results, and finished product testing prior to product release, ensuring compliance with approved specifications and cGMP requirements. Own and maintain the site's Quality Management System, including SOPs, batch record templates, specifications, and validation documentation. Manage the deviation, out-of-specification (OOS), out-of-trend (OOT), CAPA, and change control systems; ensure timely investigation, root cause analysis, and effectiveness checks. Own the product complaint handling process, including intake, investigation, trending, and determination of reportability. Lead and coordinate internal audits/self-inspections and support external audits, including FDA inspections, customer audits, and third-party certification audits; own responses to audit observations and FDA Form 483 findings. Manage supplier and contract manufacturer quality oversight, including supplier qualification, quality agreements, incoming material inspection/testing programs, and supplier corrective action requests (SCARs).Oversee equipment, facility, and process validation/qualification activities (IQ/OQ/PQ) and cleaning validation, in coordination with Operations and Engineering. Maintain the site's document control system, including SOP lifecycle management, training records, and controlled document distribution. Ensure personnel training programs meet cGMP requirements; develop and deliver quality-related training to production, QC, and support staff. Monitor and report quality metrics (e.g., right-first-time rate, deviation/CAPA aging, complaint rates, batch reject rates) to site leadership. Partner with Operations, Regulatory Affairs, R&D, and Supply Chain on new product introductions, process changes, and continuous improvement initiatives. Provide oversight on select company-wide Quality Procedures and Responsibilities. Maintain facility environmental monitoring and microbiological control programs as applicable. Support recall readiness, including periodic mock recall exercises and traceability verification.

Required Qualifications: Bachelor's degree in a scientific, engineering, or related technical discipline (e.g., Chemistry, Microbiology, Biology, Chemical Engineering) required. Minimum 3–5 years of progressive quality assurance/quality control experience in an FDA-regulated manufacturing environment (OTC drug, prescription drug, medical device, or closely related regulated industry).Working knowledge of 21 CFR Parts 210 and 211 and FDA OTC monograph requirements. Demonstrated experience with batch record review and product disposition/release decisions. Hands-on experience managing deviation, CAPA, OOS/OOT, complaint, and change control systems. Experience participating in or leading FDA inspections, customer audits, or third-party certification audits (e.g., ISO 9001, ISO 13485).Strong understanding of supplier quality management, including supplier qualification and incoming material inspection programs. Excellent written and verbal communication skills, including technical writing for SOPs, investigation reports, and regulatory correspondence. Proficiency with quality management software/eQMS platforms (e.g., Master Control, Track Wise, Veeva QMS, ETQ) and standard office software.

Preferred Qualifications: Experience specific to OTC monograph drug products, liquid/semi-solid dosage forms, or unit-dose/single-use delivery devices (e.g., enema, suppository, or similar rectal/topical delivery products).ASQ certification (Certified Quality Manager/Organizational Excellence, Certified Quality Engineer, or Certified Quality Auditor) or equivalent. Experience with process validation, cleaning validation, and equipment qualification (IQ/OQ/PQ) protocols and reports. Familiarity with combination products or Class I/II medical device requirements (21 CFR 820).Experience responding to FDA Form 483 observations or Warning Letters. Physical Requirements &

Working Conditions: Ability to work on the manufacturing floor, including exposure to production equipment, cleanroom or controlled-environment areas, and standard PPE requirements (gowning, gloves, eye protection, etc.).Ability to stand, walk, bend, and lift up to 25 lbs. as needed to access production areas and review in-process activities. Primarily an on-site role; occasional travel to supplier or contract manufacturing sites as needed (