Quality System Lead

Teil II Primäres Ziel der Stelle / Part II Primary Job Objective

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.

Teil III Mindestanforderungen an die Stelle / Part III Minimum Requirements

Bildungshintergrund und Erfahrung / Education Background and Experience

• 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

Besondere Kenntnisse / Special Knowledge

• 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

Teil IV Berufliche Verantwortung / Part IV Job Responsibilities

1. Provide technical and managerial leadership to the QMS and Compliance team lead and team

1. Provide technical and managerial leadership to the QA training team lead and team

1. Provide technical and managerial leadership to the QA auditing team lead and team

1. Provide technical and managerial leadership to the QA document team lead and team

1. 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.

1. Participate in global QMS projects and ensure global implementation and delivery aligned with regulatory and client expectations.

1. Oversee and manage the document lifecycle of SOPs and all related GMP documents at the German Manufacturing sites and QC locations.

1. Oversee and manage the Quality System for the German Manufacturing sites and Quality Control locations

1. Oversee and manage the Training System for the German Manufacturing sites and Quality Control locations

1. Manage, review and/ or approve deviations, CAPA, and changes within the area of responsibility

1. 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

1. Responsible for the planning and oversight of the annual self-inspection programs

1. Support audits and inspections, response to findings from client audit and regulatory inspection and follow up CAPAs

1. Point of contact for authority communication

1. Develop quality risk management strategy and have oversight of annual risk planning and execution of risk assessments

1. 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

1. Lead the periodic management review and annual product process review/CPV.

1. Ensure the engagement of the teams with learning and development initiatives and the performance management system

1. 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.