Quality & Vigilance SpecialistAssociate Manager
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 (QA) Key Responsibilities
- Ensure compliance with Good Distribution Practice (GDP) and maintain the Quality Management System (QMS)
- Manage product quality matters including complaints recalls returns and counterfeit investigations
- Oversee thirdparty repacking and redressing activities including product release processes
- Lead audits inspections deviation management and Corrective and Preventive Actions (CAPA)
- Maintain qualification oversight and audit status of local thirdparty partners
- Support temperature excursion assessments and product release decisions
- Coordinate packaging artwork updates with relevant internal stakeholders
- Deliver QMSrelated training to staff and act as the primary quality contact for 3PL partners
Vigilance (PV) Key Responsibilities
- Serve as the Local Safety Officer (LSO) for pharmacovigilance cosmetovigilance and device vigilance
- Maintain a local vigilance system with 24/7 coverage ensuring compliance with global and local regulatory requirements
- Manage safety data including local literature screening and reporting to health authorities
- Support aggregate safety reporting and safety signal detection activities
- Oversee vigilance agreements with third parties and ensure appropriate PV language is included in contracts
- Maintain local PV documentation records and ongoing communication with the EUQPPV and Corporate PV teams
Local Compliance Responsibilities
- Maintain local QA and PV SOPs and address noncompliance through effective CAPA implementation
- Monitor the timeliness and accuracy of safety report submissions
- Ensure appropriate training for employees and vendors on adverse event reporting requirements
- Maintain audit and inspection readiness and lead local audit activities
Other Responsibilities
- Assess workload and escalate resource requirements when necessary
- Lead mentor and develop local QA/PV team members
- Support regional and corporate initiatives and manage assigned regulatory projects
Education / Training
- Bachelors degree in Pharmacy Science or a related discipline
Work Experience
- Minimum of 3 years of Quality Assurance experience
- Minimum of 3 years of pharmacovigilance and/or medical device vigilance experience is preferred
- Experience within the pharmaceutical or healthcare industry
Required Skills & Experience
- Strong knowledge and understanding of GMP and GVP regulations guidelines and policies across pharmaceutical cosmetic and medical device sectors
- Handson experience with GMP and GVP compliance activities and regulatory inspections
- Demonstrated familiarity with local and global pharmaco cosmeto and/or device vigilance regulations and reporting requirements
- Ability to work effectively both independently and collaboratively within a matrix organization
- Strong problemsolving influencing and decisionmaking capabilities
- Excellent written verbal and interpersonal communication skills
- Strong command of spoken and written Cantonese and English
Required Experience:
Manager
