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Quality and PV Manager

Quality and PV Manager

GaldermaAntwerpen
18 dagen geleden
Functieomschrijving

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.

At Galderma we’re unique and we embrace difference.

Whether it’s the unique breadth of our integrated offering that covers Aesthetics, Consumer, and Prescription products; or our commitment to recognising and rewarding people for the contribution they make – working here isn’t like anywhere else.

At Galderma, we actively give our teams reasons to believe in our 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.

Job Title : Quality, Responsible Person and PV Manager

Location : Antwerp, Belgium / Hybrid located from Breda, Netherlands (3 days per week)

  • The Quality Manager is assigned to manage activities related to Quality Assurance and Pharmacovigilance and ensure Responsible Person duties in Galderma Benelux.
  • Lead and oversee the Quality activities for the Benelux Market
  • Verify that only authorized activities are performed and that records are accurate and of good quality.
  • Verify that initial and continuous training programs (for all employees of Galderma Benelux) are implemented and maintained.
  • Ensure the maintenance of the Quality Management System, the GDP relevant trainings and monitor the Market compliance status.
  • Oversee customer complaints, product deviation and changes affecting the products
  • Ensure compliance with GDP and Benelux regulatory framework.
  • Working within the framework of internal and external regulatory guidelines and procedures.
  • Ensure the required operational Quality activities are performed for Benelux Drug Products
  • Ensure the required operational Quality activities are performed for Benelux Medical Device Products
  • Oversee the Quality related activities for the cosmetic products
  • The Responsible Person has access to all areas, sites, stores and records which relate to the licensable activities and shall regularly review and monitor all such areas, etc. and the standards achieved or subcontract this to delegated parties and supervise the subcontracted activity.
  • The Responsible Person has the authority to take decisions with regard to the above-mentioned responsibilities and shall contact other quality departments within the Galderma Group where required, such as Quality Departments at manufacturing sites, and other Galderma entities.

Skills & Qualifications

  • Bachelor of Science Degree in Pharmacy or Life Science or equivalent
  • Fluent English, Dutch and strong French language
  • Minimum three years’ experience in the bio / pharma industry, acquired in Quality Assurance departments.
  • Experience in GxP requirements related to in prescription and OTC drug products, and medical device products
  • Good knowledge of the products sold, marketed, distributed and of the conditions necessary for their safe storage and distribution.
  • Knowledge of pharmaceutical law in the Benelux countries, and of EU pharmaceutical law
  • A good understanding of the commercial drivers of the life science industry and an associated ability to provide advice / guidance that takes these into consideration
  • What we offer in return

  • To work for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
  • A competitive compensation package with bonus structure and extended benefit package.
  • Hybrid work culture.
  • You will participate in feedback loops, during which a personalized career path will be established.
  • You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability.
  • Next Steps

  • If your application is successful and your profile is a match, we will invite you for a first virtual conversation with the recruiter.
  • The next step is a virtual conversation with the hiring manager
  • The final step is a business case and panel conversation with the extended team
  • 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.

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