The Sr. Quality Manager leads Quality Assurance, Quality Control, and Microbiology for cosmetics, OTC drugs, dietary supplements, partnering with internal teams, external stakeholders and other third-party partners to ensure product quality, compliance, and continuous improvement.
This role leads the quality teams, oversees compliance, supports audits and inspections, and promotes quality excellence. It also ensures effective quality systems and compliant product manufacture, testing, release, and distribution under 21 CFR Parts 210/211, 111, and 820, MoCRA, customer specifications and company procedures, supporting safety, efficacy, and customer satisfaction.
Quality Assurance (QA)- Lead and maintain the QMS across all product categories, ensuring compliance with applicable FDA, ISO, and cGMP requirements and effective control of policies, procedures, specifications, records, and other quality documentation.
- Direct regulatory, certification, customer, supplier, and internal audits, including inspection readiness, responses, and Management Representative responsibilities.
- Oversee deviations, complaints, change controls, CAPAs, recalls, and major investigations, ensuring timely, scientifically sound root-cause analysis, corrective action, and risk escalation.
- Provide quality oversight for product development, technology transfer, qualification, validation, laboratory methods and controls, computerized systems, environmental monitoring, water systems, stability, and retain-sample programs.
- Manage supplier qualification and performance, quality agreements, third-party laboratories, quality metrics, management reviews, product quality reviews, and risks associated with products, processes, facilities, suppliers, and operational changes.
- Build and develop a qualified, well-resourced Quality team and foster decisions grounded in consumer safety, product quality, scientific evidence, and regulatory compliance.
Quality Control (QC) and Microbiological Functions- Oversee in-coming materials (Raw ingredients and components), in-process, bulk, finished product, stability and microbial testing in accordance with regulatory requirements.
- Ensure laboratory operations follow USP, and compendial methods.
- Approve specifications, test methods, and analytical results.
- Maintain calibration and qualification of QC laboratory equipment.
- Implement effective sampling plans and statistical quality control practices.
Leadership & Cross-Functional Collaboration- Lead and mentor the QA/QC team, fostering a culture of accountability, continuous improvement, and compliance.
- Partner with Manufacturing, R&D, Regulatory, Supply Chain, and Operations to ensure quality is built into all processes.
- Train and develop employees on cGMPs, ISO standards, and company quality policies.
- Report key quality metrics and trends to senior leadership.
RequirementsEducation:- Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Engineering, or related field (Master's degree preferred).
Experience:- 8 + years of progressive Quality Management experience in a regulated manufacturing environment (OTC drugs, cosmetics, dietary supplements, or medical devices).
- Strong working knowledge of 21 CFR 210/211, 111, 820, ISO 13485, and Cosmetic GMPs (ISO 22716 preferred).
- Experience with FDA inspections, ISO audits, and third-party audits, demonstrated success in investigations, CAPA Management, change control, validation, supplier quality, laboratory controls, product disposition, risk-based quality systems, and continuous improvement initiatives.
- Proven leadership, coaching, conflict resolution, and team-development abilities.
Skills:- Strong knowledge of cGMPs and risk-based quality systems.
- Sound technical and regulatory judgment in product quality decisions.
- Clear communicator who effectively conveys quality risks and collaborates at all organizational levels.
- Organized, accountable, and adaptable in fast-paced environments; proficiency with eQMS, LIMS, or ERP systems is preferred
Benefits- Comprehensive Health Benefits package (Medical, Dental, Vision, Life, AD&D)
- Paid time off (Vacation, Sick, Holiday, Summer Fridays)
- Monthly birthday celebrations + other fun activities!
