SR Quality Assurance Manager

Job Description

Job Description

Salary: $90,000-$100,000

Summary

The Sr. Quality Assurance (QA) Manager is responsible for overseeing all quality systems and ensuring compliance with FDA cGMP regulations (21 CFR Parts 210, 211, 330 and 700), USP standards, and internal policies governing Cosmetics OTC drug manufacturing. This role provides leadership in product quality, compliance, documentation, and continuous improvement, ensuring that all products are manufactured, tested, and released in accordance with regulatory and company standards.

The Sr. Quality Control Manager works under the general direction of Quality Assurance Director.

Essential Responsibilities

• Manage and maintain the companys Quality Management System (QMS) in compliance with cGMP and FDA OTC requirements.
• Oversee and ensure proper execution of Change Control, Deviations, CAPA (Corrective and Preventive Actions), and OOS/OOT processes.
• Ensure compliance with FDA, USP, and ICH guidelines applicable to OTC drug products.
• Maintain and revise SOPs, batch records, and master manufacturing documents.
• Lead internal audits and coordinate regulatory or customer audits (FDA, third-party, etc.).
• Review and approve batch production records, analytical data, and Certificates of Analysis (CoA) prior to release of raw materials, in-process, and finished goods.
• Ensure all materials and products meet established quality specifications before disposition.
• Manage lot disposition, rework, and reprocessing decisions according to quality and regulatory standards.
• Process Questionable Material Reports (QMR), Material Destruction Records (MDR) and Reprocessing Orders (RO) as needed.\
• Collaborate closely with QC, Production, and R&D to address manufacturing or testing issues.
• Maintain data integrity across all quality-related systems and records.
• Ensure compliance with cGMP documentation practices, including controlled documents, logbooks, and records retention.
• Develop and implement training programs on cGMP and quality procedures for manufacturing, laboratory, and warehouse staff.
• Support or lead Product Quality Reviews (PQRs/APR) and trend analyses.
• Provide QA oversight during manufacturing, packaging, and labeling operations, ensuring adherence to approved procedures.
• Review and approve validation protocols and reports (equipment, process, cleaning, and computer systems).
• Monitor environmental controls and ensure utilities (e.g., purified water, compressed air) meet applicable standards.
• Ensure calibration, preventive maintenance, and qualification of critical equipment are performed and documented.
• Serve as the Secondary QA contact during FDA inspections and third-party audits; prepare and manage audit responses and CAPA implementation.
• Stay current with regulatory changes (e.g., FDA guidance, USP updates, ICH Q-series) and update quality systems accordingly.
• Drive continuous improvement initiatives to enhance efficiency, compliance, and product quality.
• Enforce adherence to safety policies, chemical hygiene, and PPE requirements.

Qualifications

To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Discretion in handling confidential and sensitive matters.
• Strong knowledge of FDA OTC regulations, USP/NF methods, and ICH stability guidelines.

Education, Experience and Licensure

• Bachelors degree in science (chemistry, pharmacy, or biology) or equivalent work experience.
• 5+ years Quality Control related experience in a cGMP OTC manufacturing environment, including 2+ years in a supervisory or managerial capacity.
• Experience with method validation, OOS investigations, and audit preparation/response.
• Experience supporting regulatory inspections, cGMP audits, and method or process validation.

PLEASE NO RECRUITERS