Senior Specialist, Commercial Quality Systems

Galderma • Miami, FL

1d • $84,800 - $106,000

About The Position

The Senior Specialist, Commercial Quality Systems is responsible for quality review, disposition, and release of commercial products marketed in the United States, including prescription, over-the-counter, and cosmetics products. The role is part of the U.S. Commercial Quality organization and helps ensure products meet applicable regulatory requirements, internal quality standards, Quality Agreements, and company procedures. It works with internal stakeholders and external partners—including contract manufacturers, laboratories, suppliers, and third-party logistics providers—to protect product quality, compliance, patient safety, and consumer safety throughout the product lifecycle.

The position also supports Quality Management System processes, supplier quality activities, product complaint investigations, audit readiness, and continuous improvement. It helps maintain compliance with applicable FDA regulations, international standards, and Galderma quality requirements.

Requirements

• Bachelor's degree in Life Sciences, Biology, Chemistry, Pharmacy, Engineering, or a related scientific discipline; an equivalent combination of education, training, and relevant experience may be considered.
• At least eight years of progressive experience in Quality Assurance, Quality Systems, Compliance, Supplier Quality, or a related quality function in a regulated industry.
• Experience supporting pharmaceutical, OTC, cosmetics, consumer healthcare, medical device, or combination product environments.
• Experience reviewing and approving quality records and supporting product release activities.
• Experience working with external manufacturers, contract laboratories, and suppliers.
• Experience with electronic Quality Management Systems.
• Working knowledge of FDA regulations and GxP requirements.
• Knowledge of pharmaceutical, OTC, and cosmetic quality systems and regulatory expectations.
• Knowledge of supplier quality management principles and Quality Agreement management.
• Understanding of Good Distribution Practices and Quality Risk Management principles.
• Knowledge of data integrity requirements and electronic quality systems.
• Strong analytical, problem-solving, investigation, and root cause analysis skills.
• Excellent written and verbal communication skills and strong technical writing and documentation skills.
• Effective organizational and project management skills, including the ability to manage multiple priorities and deadlines.
• Strong stakeholder management and collaboration skills, with the ability to influence cross-functional teams in a matrix environment.
• Commitment to continuous improvement and operational excellence.
• Must be eligible to work in the United States; the role does not offer work authorization sponsorship.

Nice To Haves

• Advanced degree in a scientific discipline or business-related field.
• ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or equivalent certification.
• Experience supporting commercial quality organizations.
• Experience working within a global or matrixed organization.
• Experience using Veeva, TrackWise, MasterControl, SAP, or equivalent systems.

Responsibilities

• Perform quality review and approval of commercial product release packages for prescription, OTC, and cosmetics products.
• Ensure release documentation is complete, accurate, and compliant with regulatory requirements, internal procedures, and quality standards.
• Review manufacturing, packaging, testing, and disposition records from contract manufacturers and contract laboratories.
• Evaluate deviations, investigations, change controls, CAPAs, and other quality events for potential impact on product disposition.
• Conduct risk-based assessments to support product release decisions and confirm products meet established quality requirements.
• Support release of imported products and related quality documentation, as applicable.
• Escalate significant quality risks and product quality concerns through established governance processes.
• Maintain product release metrics and support continuous improvement of release processes.
• Serve as a subject matter resource for QMS processes, including deviations, investigations, CAPA, change control, document control, training compliance, and risk management.
• Review and approve quality records and monitor quality system activities for timely completion and compliance.
• Support root cause investigations and the identification of effective corrective and preventive actions.
• Support implementation and continuous improvement of electronic Quality Management Systems.
• Author, review, revise, and maintain SOPs, work instructions, forms, and other quality documents.
• Support qualification, onboarding, and ongoing oversight of suppliers, contract manufacturers, contract laboratories, distributors, and third-party service providers.
• Participate in supplier risk assessments and performance evaluations, and support the development, review, and maintenance of Quality Agreements.
• Monitor supplier quality performance and support remediation activities.
• Participate in supplier audits and support timely closure of audit observations and CAPAs.
• Collaborate with Supply Chain, Procurement, Regulatory Affairs, and Global Quality teams to maintain supplier compliance.
• Support investigation, evaluation, and trending of product quality complaints for prescription, OTC, and cosmetics products.
• Collaborate with Medical Affairs, Pharmacovigilance, Supply Chain, Regulatory Affairs, and Commercial teams to assess quality trends and issues.
• Support quality assessments related to market complaints, product returns, temperature excursions, withdrawals, and recalls, as applicable.
• Identify recurring quality issues and support implementation of preventive actions.
• Support internal and supplier audits, quality assessments, and inspection readiness activities.
• Assist with preparation and follow-up of audit observations and inspection findings.
• Support implementation and verification of corrective actions resulting from audits and inspections.

Benefits

• Medical coverage
• Dental coverage
• Vision coverage
• 401(k) plan with employer match
• Paid time off
• Annual short-term incentive program, subject to plan terms and eligibility requirements
• Opportunities for growth and development

What This Job Offers

• Job Type: Full-time
• Career Level: Senior