Senior Specialist, Commercial Quality Systems

Job description

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee. At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact. 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 Regulatory & Technical Knowledge 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. Professional Competencies 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 collab