Quality System Lead

WuXi Biologics; Wuppertal; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

WuXi Biologics seeks an experienced Quality System Lead to ensure the highest standards of regulatory adherence and quality across the German site. You will own the QMS, provide technical and managerial leadership to QA teams, and drive cross-functional collaboration with manufacturing and QC locations.

The role requires extensive GMP experience and strong stakeholder management. You will oversee document control, CAPA, deviations, audits, and annual risk planning, while supporting global QMS

Qualifikationen

• At least 10 years experience in GMP environment within QA/QA-related functions.
• At least 3 years managerial or project leadership experience.
• Familiar with EMA, FDA, ICH and WHO guidelines.
• Proven track record in quality and GMP.
• Experience in development, manufacturing and testing of biological products.
• Strong leadership and organizational abilities.
• Excellent oral and written communication in English; German preferred.
• Strong stakeholder management and cross-functional collaboration.

Aufgaben

• Provide technical and managerial leadership to the QA/QMS and Compliance teams.
• Oversee the Quality Management System (QMS) across German manufacturing sites and QC locations.
• Lead audits, CAPA processes, and deviations management.
• Manage document lifecycle for GMP documents, SOPs, and related materials.
• Coordinate with manufacturing sites, QA counterparts, and clients during audits and inspections.
• Drive quality risk management and annual risk planning.
• Support authority inspections and client audits with thorough follow-up on findings.
• Lead and participate in global QMS projects and ensure alignment with regulatory expectations.
• Promote learning and development within the quality teams and drive performance management.

Kenntnisse

GMP experience

People management

Project management

Regulatory knowledge (EMA/FDA/ICH/WHO)

Leadership

Organizational skills

Interpersonal communication

English communication

German language (preferable)

Stakeholder management

QMS / GMP systems leadership

Tools

MasterControl

TrackWise

Jobbeschreibung

The Quality System Lead is a key role within the German QA. This person will play a pivotal role in ensuring the highest standards of professional excellence, regulatory adherence and quality within the business, with overall responsibility and accountability of the site Quality Management System.

• At least 10 years experience working in a GMP environment as part of a quality assurance, quality control, technical services or manufacturing operations function or other combination of experience and educational background that may otherwise satisfy the requirements of the role
• At least 3 years managerial experience as people manager and/ or project manager
• Must be familiar with general GMP requirements of EMA, FDA and other relevant standards, e.g. ICH and WHO guidelines
• Proven track record of accomplishments in the Quality and GMP
• Experience in development, manufacturing and testing of biological products
• Very good leadership skills
• Good organizational skills
• Good interpersonal communication skills
• Excellent oral & written communication skills (English; German is preferable)
• Task-oriented team player with partnering and stakeholder management skills
• Provide technical and managerial leadership to the QMS and Compliance team lead and team
• Provide technical and managerial leadership to the QA training team lead and team
• Provide technical and managerial leadership to the QA auditing team lead and team
• Provide technical and managerial leadership to the QA document team lead and team
• Ensure cross functional collaboration and leadership execution for the site Quality Management System, inclusive of GMP standards, compliance programs and owner of QA GMP system, such as Master Control, Trackwise.
• Participate in global QMS projects and ensure global implementation and delivery aligned with regulatory and client expectations.
• Oversee and manage the document lifecycle of SOPs and all related GMP documents at the German Manufacturing sites and QC locations.
• Oversee and manage the Quality System for the German Manufacturing sites and Quality Control locations
• Oversee and manage the Training System for the German Manufacturing sites and Quality Control locations
• Manage, review and/ or approve deviations, CAPA, and changes within the area of responsibility
• The role will require extensive liaison with stakeholders at the Manufacturing sites, incl. QA counterparts, as well as clients during initial contacts, due diligence, and visits, with a focus on quality topics
• Responsible for the planning and oversight of the annual self-inspection programs
• Support audits and inspections, response to findings from client audit and regulatory inspection and follow up CAPAs
• Point of contact for authority communication
• Develop quality risk management strategy and have oversight of annual risk planning and execution of risk assessments
• Support and guide the planning, preparation and follow-up for authority inspections, client audits and corporate audits performed at the German Manufacturing sites and Quality Control locations
• Lead the periodic management review and annual product process review/CPV.
• Ensure the engagement of the teams with learning and development initiatives and the performance management system
• Act as a role model for your team member and within German Quality in adherence to the WuXi corporate core values and local requirements.

20. Perform other quality-related duties and responsibilities as assigned by the supervisor.