Job Description
The Quality and Compliance Manager oversees compliant development, implementation, and continuous improvement of quality systems within a pharmaceutical manufacturing environment. This role ensures adherence to regulatory requirements, supports and executes internal and external audits, manages complaint handling processes, oversees Supplier Corrective Action Requests (SCARs), and drives the creation and reporting of departmental Key Performance Indicators (KPIs) for APR and various reporting. The manager plays a critical role in maintaining compliance with FDA, cGMP, ISO, and other applicable regulatory standards while fostering a culture of quality across the organization. The Quality and Compliance Manager ensures that all OTC drug and cosmetic products are manufactured in accordance with applicable regulatory requirements, including FDA OTC monographs, 21 CFR 210/211, 21CFR 330, 21 CFR 701/740, and ISO 22716 Cosmetic GMP guidelines. This role oversees internal and external audits, manages consumer complaint investigations, issues and tracks Supplier Corrective Action Requests (SCARs), and develops departmental Key Performance Indicators (KPIs). The manager drives continuous improvement, ensures product quality and safety, and supports compliance across all stages of manufacturing, packaging, labeling, and distribution.
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
· Ensure compliance with all applicable pharmaceutical OTC and Cosmetic regulatory requirements, including FDA, DEA, EPA, cGMP, ICH, and ISO standards.
· Lead, coordinate, and support internal and external audits (including regulatory (FDA/ISO) inspections and customer audits), Annual QMR and APR reports .
· Oversee the complaint handling system, ensuring timely investigation, documentation, and closure.
· Manage the issuance, follow-up, tracking, and effectiveness verification of SCARs.
· Develop, monitor, and report departmental KPIs to drive performance and continuous improvement.
· Maintain and enhance quality systems, policies, and procedures.
· Collaborate cross‑functionally to ensure quality and compliance expectations are met throughout the product lifecycle.
· Provide training and guidance to staff on quality and compliance requirements.
· Maintain compliance with OTC drug regulations, cosmetic labeling laws, and GMP requirements.
· Ensure quality systems (CAPA, change control, deviations, document control, etc) meet regulatory expectations.
· Provide training to staff on OTC and cosmetic GMPs, quality procedures, and compliance requirements.
· Collaborate with R&D, Regulatory Affairs, Production, and Supply Chain to ensure Conduct routine internal audits of manufacturing, packaging, labeling, and warehousing operations and prepare audit reports, corrective actions, and follow‑up activities.
· Serve as the primary point of contact during external (supplier and customer) audits and regulatory (FDA/ISO) inspections.
· Review and approve complaint investigations, ensuring root cause analysis and corrective actions are appropriate and effective.
· Generate and manage SCAR documentation, ensuring suppliers meet quality expectations for raw materials, packaging components, or service nonconformances.
· Monitor supplier performance and escalate recurring issues.
· Analyze quality data and trends to identify risks, gaps, and opportunities for improvement.
· Prepare monthly and quarterly KPI dashboards for leadership review.
· Maintain controlled documents, including SOPs, work instructions, and quality manuals.
· Support change control, deviation management, CAPA processes, and risk assessments.
· Ensure timely escalation of quality issues and support cross‑functional problem‑solving.
· Lead quality review meetings and contribute to strategic quality planning.
· Ownership and facilitation of Annual QMR and Annual Product Review (APR) reports.
· Support OTC monograph compliance, including formula verification and label review.
· Ensure cosmetic product labeling meets 21 CFR 701/740 requirements.
· Prepare monthly and quarterly KPI dashboards for leadership.
· Support deviation investigations, CAPA development, and risk assessments.
· Participate in continuous improvement initiatives.
Knowledge, Skills and Abilities
· Strong understanding of FDA regulations, cGMP, ICH guidelines, ISO 9001/13485, and other relevant pharmaceutical quality standards (OTC drug regulations/21CFR 330, including FDA OTC monographs, 21 CFR 210/211, and drug listing requirements, cosmetic regulations, including 21 CFR 701/740, ISO 22716, and global cosmetic compliance considerations.)
· Knowledge of quality systems such as CAPA, change control, deviation management, and document control.
· Familiarity with root cause analysis tools (5 Whys, Fishbone, FMEA).
· Understanding of supplier quality management and SCAR processes.
· Knowledge of data analysis and KPI development for quality performance monitoring.
· Understanding and familiarity with annual reporting for regulatory agencies (APR)
· Understanding and familiarity with compliance and risk management
· Familiarity with ESG compliance.
· Understanding of raw material and packaging component specifications for OTC and cosmetic products.
· Knowledge of complaint handling requirements for both OTC and cosmetic categories.
· Proficiency with root cause analysis tools (5 Whys, Fishbone, FMEA).
· Excellent analytical and problem‑solving skills with a data‑driven mindset.
· Strong written and verbal communication skills for audit interactions, reporting, and cross‑functional collaboration.
· Ability to manage multiple priorities in a fast‑paced, regulated environment.
· High attention to detail and accuracy in documentation and reporting.
· Strong leadership and interpersonal skills with the ability to influence without authority.
· Proficiency in quality management software and Microsoft Office tools.
· Ability to interpret and apply regulatory requirements to operational processes.
· Strong analytical and problem‑solving skills with a focus on regulatory compliance.
· Excellent communication skills for interacting with auditors, suppliers, and internal teams.
· Strong understanding of cGMP and pharmaceutical quality systems.
· Familiarity with OTC monograph compliance and/or cosmetic labeling requirements.
Qualifications
· Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, or a related field preferred. Equivalent experience will be considered in lieu of degree.
· 5+ years of experience in pharmaceutical OTC drug/cosmetics/medical manufacturing quality assurance or compliance.
· Experience leading audits and interacting with regulatory agencies.
· Demonstrated experience with complaint handling, SCAR management, and KPI reporting.
· Certifications such as ASQ CQA, CQE, Six Sigma or ISO 22716 training are a plus.
Working Condition
The Quality and Compliance Manager works primarily in an office environment within an FDA-regulated OTC manufacturing facility, with interaction in production, laboratory, warehouse, and packaging areas. The position requires regular collaboration with Quality, Regulatory, Production, Operations, and Supply Chain personnel to ensure compliance with applicable FDA regulations, Good Manufacturing Practices (GMPs), company policies, and quality standards.
The role involves presence in manufacturing and laboratory environments where exposure to varying temperatures, noise levels, chemical odors, and moving equipment may occur. Appropriate personal protective equipment (PPE) must be worn when entering designated operational areas in accordance with company safety requirements.
Physical requirements include prolonged periods of sitting and computer use, effective verbal and written communication, walking through the facility, and occasionally lifting or moving items weighing up to 25 pounds. The position may require extended work hours during audits, regulatory inspections, quality investigations, compliance initiatives, or other business-critical activities. If travel is required, it may be minimal 5-10%.
Pay: $100,000.00 - $115,000.00 per year
Benefits:
- 401(k)
- AD&D insurance
- Dental insurance
- Employee assistance program
- Employee discount
- Health insurance
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Work Location: In person
