Quality Management Supervisor
vor 2 Wochen
We are seeking a highly skilled Quality Management Supervisor to join our team at WuXi AppTec. The successful candidate will be responsible for overseeing the implementation and maintenance of our Quality Management System (QMS) to ensure compliance with regulatory requirements.
Key Responsibilities- Lead and manage employees to ensure they are fully trained and equipped to perform their duties effectively.
- Develop and implement processes and procedures to align with regulatory requirements, including EU, FDA, and other relevant foreign regulatory bodies.
- Ensure 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.
- Provide leadership to the organization in QMS processes, including Internal and External Audit Management, Management Review, Change Control, Document Control, Supplier Management, CAPA, NCE.
- Maintain, enforce, and manage 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 in cross-functional teams and projects representing quality in a positive and compliant manner.
- 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 the 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 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. Guide non-compliance situations using creative problem-solving skills.
- 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.
- 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).
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