Quality & Vigilance SpecialistAssociate Manager

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 bodys 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.

Quality Assurance

• Responsible as the Quality Representative (QR) for ensuring GDP compliance
• Ensure all aspects of GDP are implemented and maintained to current QMS required by global and/or local regulations
• Develop maintain and assist in the implementation of QMS
• Manage Product Quality Complaints Recalls Returned products and Counterfeits
• Manage third party redressing/ repacking activities and the release to the market when applicable
• Conduct Q/PV Management Review based on KPI data and implement the actions for improvement
• Report and monitor monthly KPIs
• Manage external inspections internal audits complaints and deviations according to Galderma Corporate Standard and local written procedures and implement each CAPA timely
• Ensure affiliate 3rd parties are qualified maintained in an approved audit status and with Technical Quality Agreements (TQAs) established
• Support principal release of products received inbound including temperature excursion assessment
• Keep up to date with changes to regulations and standards and ensure relevant colleagues are advised of the implications of such changes
• Arrange and update artworks of packaging materials of registered products concerned by coordinating with Logistics Regulatory Affairs Sales and Marketing
• Conduct staff training as required by the QMS
• Act as primary quality contact person with Third Party Logistics(3PL) and as qualified person for internal quality compliance matters

Vigilance

• Responsible as the Local Safety Officer(LSO) for pharmaco- cosmeto- and device vigilance activities and acts as the local health authority vigilance contact/Qualified Person for Pharmacovigilance (QPPV)
• Nominates a back-up LSO
• Sets up and maintains a local vigilance system with 24/7 coverage and handles safety information in accordance with current valid Corporate SOPs 3rd party agreements (when applicable) and local regulatory requirements
• Implements and maintains a local Summary of Pharmacovigilance System as applicable per the local regulation
• Sets-up a local (pharmaco)vigilance generic e-mail box for exchange of safety information
• Ensure that all vendor/3rd party contracts undergo appropriate PV qualification and have appropriate vigilance language incorporated prior to the start of any activity; ensure that these contracts are archived in the local PV system and notified to Corporate PV as applicable
• Provide local data as required to support the preparation of aggregate safety reports (Periodic Safety Reports etc.) as required
• Set up appropriate procedures with departments and vigilance agreement partners at country organization level that may receive adverse event reports and ensure reconciliation is performed
• Provides Corporate PV with requested feedback on ICSR Reconciliation
• Keeps up-to-date on local pharmaco- cosmeto- and device vigilance legislations and keeps Regional/Corporate PV informed of any change
• Establish a process to screen and monitor local scientific literature local regulatory websites and digital platforms for case reports involving Galderma medicinal cosmetic and device products or any active substance contained in a Galderma product including translation if required
• Conducts signal detection and monitors the safety of products and informs Regional/Corporate PV of any changes that may impact the benefit-risk profile
• Keeps all local vigilance records and files updated and archived in accordance with Galderma procedures and local regulations
• Provides the EU-QPPV with the 24-hour contact details and keeps the EU-QPPV informed on any change
• Informs Corporate PV of all 3rd party agreements to be signed locally
• Informs Corporate PV of non-interventional studies and interventional clinical trials conducted with marketed products whether sponsored or supported by Galderma Hong Kong
• Maintenance of Local Compliance
• Establishes and maintains necessary local QA and PV SOPs and supportive documents
• Documents non-compliance with proposed CAPA(s)
• Implements and follows-up CAPA(s) until resolution of the issue
• Ensures and monitors compliance with local regulations regarding reporting of adverse drug reactions/undesirable effects/device adverse events reported with marketed Galderma medicinal cosmetic and device products
• Monitors the compliance with the timeliness of submissions to local health authorities of any safety reports
• Performs control and oversight of the local vigilance system
• Ensures a process in place to guarantee all employees in Galderma Hong Kong as well as local 3rd parties external vendors and local partners are adequately trained (induction and yearly refresher) in Adverse Event reporting and ensure that accurate and updated training records are available for that purpose
• Ensures pharmaco- cosmeto- device vigilance audit and inspection readiness at all times in Galderma Hong Kong
• Is the primary point of contact and leads the local vigilance audits and inspections efforts within Galderma Hong Kong
• Develops CAPA plans and drives local implementation

Other

• Periodically assesses workload in order to ensure local resources are adequate to maintain the quality and compliance of QA and PV activities; if needed to escalate the need of resources to Regional teams
• Lead and manage all local QA and PV staff and ensure that they are competent trained and developed effectively to perform their roles
• Participates in Corporate or Regional project initiatives and meetings if any
• Manage regulatory projects as assigned
• Other agreed tasks as assigned by manager