Senior Quality Assurance Specialist

at  Galderma

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.
We’re currently seeking a Senior Quality Assurance Specialist to join our team in North Sydney. This role is crucial in maintaining and enhancing our Quality Management System and ensuring compliance with both internal and external regulatory guidelines and procedures. In this role, you will be reporting directly to Head of Quality, JPAC and to local Managing Director based in Sydney.

Key Responsibilities

• Act as the Responsible Person (RP) for maintaining Importer’s and Wholesaler’s Licence.
• Ensure compliance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) when applicable.
• Manage product complaints and coordinate product recalls.
• Ensure proper labelling and handling of products, including review of secondary packaging and redressing.
• Implement and maintain the QMS to ensure effective processes.
• Own quality systems such as internal audits, change control, management reviews, deviation management, and CAPA.
• Create and update local SOPs in line with Corporate Policies and SOPs.
• Compile and update training manuals; conduct induction and refresher training for staff.
• Ensure quality agreements and approved audit status for affiliate third parties.
• Authorise product samples ensuring traceability and integrity.
• Decide on the disposition of trade returns and damaged products; authorize release from quarantine.
• Maintain, analyse, and report Quality KPIs.
• Foster cross-functional relationships, attend relevant meetings, and represent the Affiliate.

Skills & Qualifications

• Bachelor of Science Degree in Pharmacy or Life Science with a local Pharmacy Practice license
• Minimum 5 years Quality Assurance experience in pharmaceutical and medical devices and/or cosmetic industry
• Strong understanding of regulatory requirements and quality management systems.
• Excellent leadership and communication skills.
• Ability to work independently and as part of a team.
• Detail-oriented with strong analytical and problem-solving abilities.

What we offer in return

We are committed to providing a competitive and attractive salary package along with addition benefits such as:

• Professional development, offering opportunities for training, education, and career advancement
• Employee recognition and rewards
• Health and wellness benefits
• We plan to set you up for success

You will also be working for an organisation that embraces diversity & inclusion. We believe we deliver better outcomes by reflecting the perspectives of our diverse customer base.

Next Steps

• If your application is successful and your profile is a match, our recruiter will reach out to you directly and engage you in the first conversation regarding this role.
• The next step is a virtual conversation with the hiring manager.
• The final step is a panel conversation face to face with the extended team.
• Please note, Galderma is NOT partnering with any Recruitment agencies for this role.

Our people make a difference.
At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

• Act as the Responsible Person (RP) for maintaining Importer’s and Wholesaler’s Licence.
• Ensure compliance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) when applicable.
• Manage product complaints and coordinate product recalls.
• Ensure proper labelling and handling of products, including review of secondary packaging and redressing.
• Implement and maintain the QMS to ensure effective processes.
• Own quality systems such as internal audits, change control, management reviews, deviation management, and CAPA.
• Create and update local SOPs in line with Corporate Policies and SOPs.
• Compile and update training manuals; conduct induction and refresher training for staff.
• Ensure quality agreements and approved audit status for affiliate third parties.
• Authorise product samples ensuring traceability and integrity.
• Decide on the disposition of trade returns and damaged products; authorize release from quarantine.
• Maintain, analyse, and report Quality KPIs.
• Foster cross-functional relationships, attend relevant meetings, and represent the Affiliate