Overview

　　This position is responsible for organizing, planning and managing the personnel, systems and resources critical to the daily operation of the department(s). The Manager works cross functionally to ensure processes and procedures in place to align with regulatory requirements.

　　Responsibilities

　　Lead and manage employees to ensure that employees are fully trained, providing adequate leadership, mentoring, and support. Including active maintenance in keeping the site current with cGMP, including EU, FDA and other relevant foreign regulatory bodies.

　　Ensuring that the Quality Management System is maintained in compliance with WuXi AppTec policies, ISO 17025, and any other applicable standards and regulations.

　　Lead Quality Management Planning activities to ensure continued compliance, metrics, and other activities necessary for changes impacting the QMS.

　　Providing leadership to the organization in QMS processes including Internal and External Audit Management, Management Review, Change Control, Document Control, Supplier Management, CAPA, NCE.

　　Maintaining, enforcing, and managing a compliant and effective QMS, lean QMS structures and documents throughout.

　　Lead/Support client, regulatory and accreditation audits and inspections; respond to inspection findings in a satisfactory and timely manner.

　　Lead and/or participate on cross-functional teams and projects representing quality in positive and compliant manner. Work and interact in a collaborative manner at all levels of the organization.

　　Support from the QA perspective validation / qualification activities for the facility, utilities and equipment.

　　Responsible for hiring, transfer, promotion, discharge and salary changes of staff.

　　Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.

　　Ability to work in a team environment and independently as required.

　　Contributes to the overall operations and to the achievement of departmental goals.

　　Perform job specific tasks in compliance with applicable Regulations, International. Standards, and WuXi AppTec Policies and Standard Operating Procedures.

　　Coordinate and support the alignment of US Quality Management systems.

　　Responsible for the oversight of the Quality Assurance (QA) team.

　　Participate/lead continuous improvement initiatives both within QA and cross functionally.

　　Develop, implement and approve policies and procedures.

　　Review, approve, and perform investigations. Provide guidance for non-compliance situations using creative problem-solving skills.

　　Other duties as assigned.

　　Qualifications

　　Experience / Education

　　Previous role in QMS management in medical device, pharma or laboratory regulated quality management systems.

　　Laboratory Management System knowledge would be a plus.

　　Bachelor’s Degree or higher.

　　Proficient knowledge of Quality Systems regulations and standards.

　　Experience managing, hosting EU, FDA, Notified Body and/or customer audits.

　　Minimum 5 years of experience.

　　ISO 17025 and cGMP experience.

　　Must have 3 or more years of experience managing personnel.

　　Knowledge / Skills / Abilities:

　　Ability to use judgment, clear problem-solving and decision-making skills.

　　Ability to work under limited supervision and to handle complex problems.

　　Excellent organizational and interpersonal skills.

　　Ability to communicate effectively with all levels of the organization.

　　Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices.

　　Proficient in Oral & Written communication skills.

　　Able to communicate (read, write, speak) in German and English

　　Proficient in Microsoft (Excel, Word, Outlook).

　　Physical Requirements:

　　Must be able to work in an indoor office setting

　　Must be able to wear appropriate PPE

　　Must be able to work in environment with minimal noise levels

　　Ability to stand for long periods of time

　　An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

　　This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

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　　Job Locations DE-Martinsried

　　Job ID 2023-12498