FDA 21 CFR

Parts 210/211/330, ISO standards, ICH Q10, and applicable cosmetic regulations. The Change Control Manager acts as the central coordinator between Quality, R&D, Operations, Engineering, Regulatory Affairs, and Supply Chain to maintain a state of control and ensure product quality, safety, and regulatory compliance. Quality Specific Responsibility Ensure all operations are conducted in compliance with applicable regulatory requirements, Good Manufacturing Practices (GMP), and company quality standards. All Hydrox Laboratories Supervisors and Managers are responsible for understanding, implementing, updating and maintaining adherence to Standard Operating Procedures (SOPs), ensuring employees follow approved procedures, and promptly addressing or reporting any deviations from established quality or regulatory requirements. Every leader is accountable for maintaining a culture of quality and ensuring Hydrox standards consistently meet or exceed both internal expectations and customer requirements. Duties & Responsibilities

Lead the end‑to‑end change control process, including intake, risk assessment, impact analysis, approval routing, implementation oversight, and closure.
Ensure all changes comply with FDA, c

GMP, OTC

monograph, and cosmetic regulatory requirements.

Facilitate cross‑functional change review board (CRB) meetings and maintain alignment across departments.
Maintain and continuously improve the Change Control System within the company's electronic Quality Management System (eQMS).
Monitor change progress, escalate delays, and ensure timely completion of actions, verifications, and documentation.
Partner with Regulatory Affairs to determine regulatory filing requirements and ensure appropriate submissions when needed.
Provide training and guidance to employees on change control procedures and best practices.
Develop and track KPIs related to change control performance, cycle time, and compliance.
Support internal and external audits by providing documentation, responding to observations, and implementing corrective actions.
Ensure changes are properly validated, qualified, or verified according to established protocols.
Review and evaluate change requests for completeness, accuracy, and regulatory impact.
Conduct or coordinate risk assessments (e.g., FMEA, hazard analysis) for proposed changes.
Maintain accurate and compliant documentation within the eQMS.
Ensure that affected SOPs, batch records, specifications, and quality documents are updated and approved.
Coordinate with Engineering and Operations to ensure equipment or process changes are properly qualified.
Verify that training requirements are met before changes go live.
Prepare reports, metrics, and summaries for management review.
Support deviation, CAPA, and complaint investigations when changes intersect with quality events.
Ensure proper archival and traceability of all change control records.
Works with suppliers and customers to ensure changes are established and communicated for the organization. Knowledge, Skills and Abilities
Strong understanding of FDA cGMP regulations (21 CFR 210/211/330) for OTC drug manufacturing.
Familiarity with cosmetic regulations, including FDA guidelines and international requirements (e.g., EU Cosmetic Regulation).
Knowledge of ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System).
Understanding of validation principles (IQ/OQ/PQ), process controls, and quality systems.
Working knowledge of eQMS platforms and document control systems.
Awareness of supply chain, manufacturing, and packaging operations in a regulated environment.
Understanding of risk analysis and application of risk assessment (FMEA)
Strong analytical and critical‑thinking skills with the ability to assess complex technical changes.
Excellent communication and facilitation skills to lead cross‑functional teams.
Ability to interpret and apply regulatory requirements to real‑world manufacturing scenarios.
High attention to detail and strong organizational skills.
Ability to manage multiple projects simultaneously and meet deadlines.
Proficiency in writing clear, concise, and compliant documentation.
Ability to influence without authority and drive accountability across departments.
Strong problem‑solving skills with a continuous improvement mindset.
knowledge of FDA regulations, cGMP, and quality systems. Qualifications
Associates or higher degree in Engineering, Chemistry, Pharmaceutical Sciences, Quality Assurance, or a related field (Master's a plus). Experience will be considered in lieu of degree.
3+ years of experience in pharmaceutical, OTC, medical device or cosmetics manufacturing within a regulated environment.
Experience managing or working within a formal change control system.
Experience with eQMS platforms (e.g., MasterControl, Veeva, TrackWise, QT9).
Experience supporting audits (FDA, ISO, customer) strongly preferred.
Certifications such as

ASQ CQA, ASQ

CQE, or PMP are a plus. Working Condition This position primarily works in an office environment with frequent interaction in manufacturing, engineering, warehouse, laboratory, and packaging areas of an FDA-regulated OTC pharmaceutical and cosmetic manufacturing facility. Regular use of computers, electronic quality management systems (eQMS), document management systems, engineering software, and standard office equipment is required to administer change controls, review technical documentation, and coordinate cross-functional projects. The position requires frequent sitting, standing, walking, and the ability to move throughout the facility to evaluate equipment, processes, and manufacturing operations, participate in change control assessments, conduct implementation reviews, and collaborate with Quality, Engineering, Operations, Regulatory Affairs, and Supply Chain personnel. Occasional lifting of up to 25 pounds may be required. The employee must be able to perform prolonged computer work and review technical documentation with a high degree of accuracy. While on the manufacturing floor, the employee is required to wear appropriate personal protective equipment (PPE) and comply with all safety, quality, and Good Manufacturing Practice (GMP) requirements. Exposure to manufacturing noise, chemical odors, varying temperatures, moving machinery, and production activities may occur. The position may require occasional extended hours to support change implementations, equipment qualifications, validation activities, audits, regulatory inspections, or other business needs. This job description lists the major duties and requirements of the job and is not all-inclusive. Incumbent may be expected to perform job-related duties other than those contained in this document and may be required to have specific job-related knowledge and skills.

Pay:

$90,000.00 - $110,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Disability insurance Employee assistance program Health insurance Life insurance Paid time off Tuition reimbursement Vision insurance

Work Location:

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