Quality Assurance Associate

Job content

Company Overview

Galderma, the world’s largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com

Job Description

In this challenging and dynamic role this person will:

• Lead and manage activities related to Quality Assurance for the Swiss Market
• Maintain the Quality Management System and monitor its compliance status with the focus on the Swiss Market
• Deputize the Swiss RP (Deputy FvP)
• Contribute proactively, functioning responsibly and autonomously while working within the framework of internal and external regulatory guidelines and procedures

Job Responsibilities

• Deputize the Responsible Person for the direct supervision of the company concerning all activities covered by the Swissmedic Establishment license
• Responsible for compliance with GDP guidelines defined for the regulatory purposes (AMBV, GDP guidelines (2013/C 343/01)
• Verification of entitlement to benefits in accordance with the requirements of Swiss legislation
• Lead and perform Quality and compliance specific tasks including but not limited to processing product complaints, review of information about secondary packaging/redressing, ensure proper labelling of products at the distributor, and product recall coordination
• Manage the creation/update of local SOPs to reflect local practices in accordance with Corporate Policies and SOPs
• Implementing and maintaining the QMS to ensure that required processes are established and effective
• Actively contribute in the management of quality systems such as, but not limited to: internal audits/self-inspection, change control, management reviews, deviation management and CAPA
• Compile and update training manuals, undertake induction training and refresher training related to QMS for local affiliate staff
• Ensure product samples are authorized with maintained traceability and product integrity
• Decision of disposition for trade returns and damaged products
• Authorization of any product from quarantine to approved product status
• Maintenance, analysis and reporting of Quality KPIs
• Ensure local repackaging of products are performed in accordance with specifications and required licenses
• Develop and manage effective relationship with competent authority and Galderma Global teams
• Foster and maintain good cross-functional relationship with other departments; attend cross-functional meetings and represent the local operating site where necessary
• Represent the local operating site in the relevant committees of the professional/industry associations, if necessary Deputy Authorized Representative for Medical Device Products

Minimum Requirements

• Bachelor of Science Degree in Pharmacy or Life Science
• Minimum three years’ experience in the bio/pharma industry, preferably acquired in Regulatory Affairs or Quality Assurance departments
• Experience in cosmetics, prescription, OTC and medical devices products
• Good knowledge of regulated products and the country/regional regulations and governmental authorities
• Has the power to take decisions and give instructions to all employees to in his/her field of activities to ensure compliance with legal requirements
• Decision of release or non-release of incoming batches independently from the executive board
• Decision of batch recalls and information of the executive board accordingly
• Able to read, write and speak German and English fluently. Contact with authority will be in German
• Thorough knowledge of the local regulatory Guidelines and Corporate Standards and applicable laws
• 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
• Good, positive, and proactive communication and the ability to foster excellent working relations with external customers including the health authorities, industry associations and internal stakeholders
• Skills such as project management, problem solving, ability to present information in easily understood format at internal and external meetings, good time management, negotiation, and interpersonal skills
• Ability to work both independently or as part of a team as required
• Be proactive, motivated and a self-starter
• Be able to balance company commercial needs with achieved compliance
• Ability to think strategically and innovatively for resolution of quality issues
• Commitment to continued improvement in department processes and performance
• Strong team player, assisting others with workload peaks and the management of challenging situations
• Proactively contributes to a positive team attitude and highly productive work environment