Senior Specialist, Commercial Quality Systems

The Opportunity

The Senior Specialist, Commercial Quality Systems is responsible for the quality review, disposition, and release of commercial products marketed in the United States, including Prescription (Rx), Over-the-Counter (OTC), and Cosmetics products. This role serves as a key member of the U.S. Commercial Quality organization and ensures products are released in accordance with applicable regulatory requirements, internal quality standards, Quality Agreements, and company procedures. The position collaborates with internal stakeholders and external business partners, including contract manufacturers, contract laboratories, suppliers, and third-party logistics providers, to ensure product quality, compliance, patient safety, and consumer safety throughout the product lifecycle. In addition, the role supports Quality Management System (QMS) processes, supplier quality activities, product complaint investigations, audit readiness, and continuous improvement initiatives to ensure compliance with applicable FDA regulations, international standards, and Galderma quality requirements.

Key Responsibilities

Product Release & Disposition (40%)

• Perform Quality review and approval of commercial product release packages for Rx, OTC, and Cosmetics products.
• Ensure all release documentation is complete, accurate, and compliant with applicable regulatory requirements, internal procedures, and quality standards.
• Review manufacturing, packaging, testing, and disposition records provided by contract manufacturing organizations (CMOs) and contract laboratories.
• Evaluate deviations, investigations, change controls, CAPAs, and other quality events for potential impact on product disposition decisions.
• Conduct risk-based assessments to support product release decisions and ensure products meet established quality requirements.
• Support release of imported products and associated quality documentation, as applicable.
• Escalate significant quality risks or product quality concerns through established quality governance processes.
• Maintain product release metrics and support continuous improvement of release processes.

Quality Management Systems (25%)

Serve as a subject matter resource for Quality Management System processes, including: Deviations, Investigations, CAPA, Change Control, Document Control, Training Compliance, Risk Management.

• Review and approve quality records in accordance with procedural and regulatory requirements.
• Support root cause investigations and identification of effective corrective and preventive actions.
• Monitor quality system activities to ensure timely completion and compliance with established requirements.
• Support implementation and continuous improvement of electronic Quality Management Systems (eQMS).
• Author, review, revise, and maintain SOPs, work instructions, forms, and quality documents.

Supplier Quality Management (20%)

• 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.
• Support development, review, and maintenance of Quality Agreements.
• Monitor supplier quality performance and support remediation activities when required.
• Participate in supplier audits and ensure timely closure of audit observations and CAPAs.
• Collaborate with Supply Chain, Procurement, Regulatory Affairs, and Global Quality teams to maintain supplier compliance.

Product Complaints & Market Quality (10%)

• Support investigation, evaluation, and trending of product quality complaints for Rx, OTC, and Cosmetics products.
• Collaborate with Medical Affairs, Pharmacovigilance, Supply Chain, Regulatory Affairs, and Commercial teams to assess quality-related trends and issues.
• Support quality assessments associated with market complaints, product returns, temperature excursions, withdrawals, and recalls, as applicable.
• Identify recurring quality issues and support implementation of preventive actions.

Audit & Compliance Support (5%)

• Support internal audits, supplier audits, and quality assessments.
• Participate in inspection readiness activities.
• Assist in the preparation and follow-up of audit observations and inspection findings.
• Support implementation and verification of corrective actions resulting from audits and inspections.

Qualifications

Education: Bachelor's Degree in Life Sciences, Biology, Chemistry, Pharmacy, Engineering, or a related scientific discipline required. An equivalent combination of education, training, and relevant experience may be considered in lieu of the stated educational requirements.

Experience: Minimum of eight (8) years of progressive experience within 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 (eQMS).

Preferred Qualifications

• 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.

Knowledge, Skills, and Competencies

• 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 (GDP).
• Understanding of Quality Risk Management principles.
• Knowledge of data integrity requirements and electronic quality systems.
• Strong analytical and problem-solving skills.
• Strong investigation and root cause analysis capabilities.
• Excellent written and verbal communication skills.
• Strong technical writing and documentation skills.
• Effective organizational and project management skills.
• Ability to manage multiple priorities and deadlines.
• Strong stakeholder management and collaboration skills.
• Ability to influence cross-functional teams in a matrix environment.
• Commitment to continuous improvement and operational excellence.