Establishes, maintains, and continuously enhances the local PV Quality Management System in alignment with global PV standards and regulatory requirements.
Owns PV quality documentation governance, including SOP frameworks, work instructions, local addenda, document control, and archival processes.
Authors and maintains compliance‑specific procedures related to deviations, CAPAs, compliance monitoring, and inspection readiness.
Conducts ongoing compliance monitoring of PV systems, processes, and activities to assess adherence to regulatory and internal requirements.
Tracks, trends, and reports PV quality and compliance metrics (e.g., KPIs, QPIs, deviations, CAPAs, audit findings) to PV leadership.
Manages PV quality events, including deviation investigations, root cause analysis, CAPA development, effectiveness verification, and closure.
Coordinates audit and inspection readiness activities, including documentation preparation, mock inspections, and tracking of inspection outcomes.
Supports regulatory change impact assessments and ensures timely updates to SOPs, training materials, and quality documentation.
Collaborates with Global PV Compliance, Quality Assurance, and cross‑functional partners to align oversight activities and remediation efforts.
Ensures PV training requirements are defined, current, and audit‑ready; supports delivery of compliance‑focused training as needed.
Identifies compliance risks, quality trends, and opportunities for continuous improvement and escalates issues appropriately.
Contributes to PV system enhancements, inspections readiness planning, and quality initiatives supporting regulatory compliance and operational excellence.
Requirements
Advanced degree (Master's, PharmD, MD, PhD) in life sciences, pharmacy, medicine, or a related field required.
6+ years of experience in pharmacovigilance quality, compliance, or safety operations within the pharmaceutical, biotechnology, or medical device industry.
Demonstrated experience with PV quality systems, deviation and CAPA management, and regulatory inspection support.
In‑depth knowledge of U.S. and international PV regulations, including FDA requirements, ICH guidelines, and GVP modules.
Strong understanding of PV systems, safety reporting processes, and quality oversight best practices.
Proven ability to conduct compliance assessments, root cause analyses, risk evaluations, and trend analyses.
Experience supporting regulatory inspections and internal audits.
Strong organizational, analytical, and
Benefits
Health insurance
Additional Information
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.
Title: Pharmacovigilance Compliance and Oversight Manager
Job Summary
The Pharmacovigilance (PV) Compliance and Oversight Manager, U.S. Region is responsible for overseeing and maintaining the local PV quality management system (QMS) to ensure compliance with applicable U.S. and global pharmacovigilance regulations, company policies, and industry standards. The role provides an independent quality and compliance perspective across PV activities, supporting inspection readiness, CAPA management, compliance monitoring, and continuous improvement initiatives.
This position partners closely with the Local Safety Officer (LSO), Senior PV Manager, and Global PV Compliance and Quality teams. While strategic regulatory engagement is led by PV leadership, the PV Compliance and Oversight Manager is responsible for operational oversight, documentation, monitoring, and quality execution within the affiliate.
Galderma · Boston