GxP Coordinator Germany - Dermatology

Arbeitsort: Neu-Isenburg 63263, Hessen, Deutschland, hybrides Arbeitsmodell 
Vertragsart: Dauerhaft unbefristete Festanstellung in Vollzeit, office based contract
Stelle ID: 3916 

LEO Pharma has embarked on an ambitious journey to become the preferred Dermatology care partner improving people’s lives around the world – and that is why we need you.
 
As GxP Coordinator in Germany, you will get the opportunity to shape the future and help people with skin diseases live more fulfilling lives by advancing the standard of care.

Your role

The GxP Coordinator is the owner of GxP related coordination tasks within LEO Germany, and serves as coordinator, administrator and main overall contact for GxP related functions (as per German Drug Law), e.g. the roles Stufenplanbeauftragter (Graduated Plan Officer), Informationsbeauftragter (Information Officer), Großhandelsbeauftragter (Wholesales Officer), and the respective authorities.

The GxP Coordinator is overall accountable for accurate filing, archiving and administrative upkeep of local GxP documentation and escalates substantive regulatory or legal issues to the local management and the respective roles as mentioned above. 

Responsibilities 

Document & process governance

• Maintain, file and archive original GxP documentation to meet retention, retrievability and audit/inspection requirements. Maintain the respective sharepoint sites
• Coordinate creation, maintenance and controlling of SOPs, work instructions and checklists for Stufenplan, Information and Wholesale responsibilities.

Regulatory & authority liaison

• Prepare, coordinate and respond to authority correspondence, notifications and information requests; ensure timely, compliant responses – in coordination with the respective stakeholders
• Support GxP audits and inspections and related follow-up activities; maintain inspection logs and evidence; coordinate CAPA tracking and closure.

Role administration & support

• Maintain lists of responsible persons and contact details for GxP roles; coordinate handovers and rolerelated documentation.
• Support role holders in executing required processes and documentation and coordinate these activities.
• Together with other GxP functions, evaluate the adequacy of potential new candidates for GxP relevant roles acc. to German Drug Law, when and if required, before submission to the authorities

Compliance monitoring & change impact

• Track national (and EU) changes in regulations, guidances and legislation; perform impact assessments and implement required process updates. Reporting & management information

• Produce regular compliance reports and KPIs for local management (document status, open actions, inspection readiness).

Training & stakeholder advice

• Provide training and advisory support for employees and partners on GxP procedures and regulatory requirements.

Wholesale & GDP-related tasks

• Support GDP controls for wholesale activities (license checks, distribution documentation, traceability), when needed.

Graduated Plan Officer support

• Support the Graduated Plan officer(-s) during ad hoc activities, e.g. crisis situations: Tasks may include: Organising meetings, preparing agendas, writing minutes, administration of documentation, preparation of communication

Working conditions

• Travel as needed to support inspections or regulatory meetings.
• Possible oncall availability for critical regulatory events 

Your qualifications 

To succeed in this role, we imagine that you have the following qualifications: 

• Relevant qualification with GxP experience and / or degree in Pharmacy, Life Sciences, Biotechnology, Natural Science or equivalent
• ideally practical experience in a GxP environment; experience with Stufenplan/Information officer/Wholesale processes is a plus.
• Solid understanding of GxP and national/EU regulatory frameworks.
• ideally experience supporting inspections/audits and working with CAPA systems.
• ideally familiarity with QA systems, CAPA/issue tracking and preparing compliance reports/KPIs.
• Proficient with document management systems and MS Office.
• Behavioural & technical competencies
• Structured, process-oriented, and detail-focused.
• Action- and goal oriented

Contact and application.

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.

Beyond the skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet. 
 
At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.
 
For certain positions, LEO Pharma might complete a background check conducted by a third party.