Aktuelle Jobs im Zusammenhang mit Director of Quality Assurance - Planegg, Bayern - WuXi AppTec
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Director of Quality Assurance
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Planegg, Bayern, Deutschland WuXi AppTec VollzeitJob SummaryWe are seeking a highly experienced and skilled Director of Quality Assurance to join our team at WuXi AppTec. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance in our operations.Key ResponsibilitiesCoordinate our Quality Assurance organization and ensure compliance with...
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Business Development Director
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Planegg, Bayern, Deutschland WuXi AppTec VollzeitJob Title: Business Development DirectorJob Summary: We are seeking a highly skilled Business Development Director to join our team at WuXi AppTec. The successful candidate will be responsible for expanding our LTD Division business in assigned territories, managing the sales process, and leading a team to achieve Division targets.Key...
Director of Quality Assurance
vor 2 Monaten
Job Summary
We are seeking a highly experienced and skilled Director of Quality Assurance to join our team at WuXi AppTec. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance in our operations.
Key Responsibilities
- Coordinate our Quality Assurance organization based in Germany and ensure the effective implementation of quality systems and processes.
- Set up and manage our Quality Assurance office, including related systems and processes.
- Be responsible for the certification of our manufactured products on behalf of clients for clinical and commercial purposes.
- Provide quality and compliance guidance to our staff and sites, and assist in the resolution of quality issues in a timely manner.
- Host regulatory inspections to obtain necessary licenses and authorizations to support our quality review and certification processes.
- Host major client audits related to our Quality Assurance organization and ensure their successful completion.
- Properly allocate resources to all projects and activities, and make adjustments as needed to ensure that every project meets timeline and quality requirements.
- Communicate with our customers in a timely manner and ensure their satisfaction, meeting their requirements by understanding their needs.
- Communicate across our organization and sites to ensure the effective implementation of Quality Assurance processes and certification.
- Recruit new staff and ensure that they receive proper and adequate training, coaching them to continuously improve their work skills.
Requirements
- PhD or Master's degree in pharmaceutical, chemical, or analytical sciences or equivalent degree, with proficiency in drug product manufacturing processes and GMP regulations.
- More than 10 years of experience in Quality Assurance or other relevant functions in a regulated pharmaceutical environment, with more than 6 years of people leadership and team management experience.
- More than 5 years of experience in the EU Qualified Person role, with necessary qualification and certification to act as an EU Qualified Person.
- Excellent communication and presentation skills in German and English.
- Demonstrated ability in problem-solving, communications, quality system implementation, and team building.
- Demonstrated ability of pro-active thinking and setting up systems for the prevention of quality issues.
- Demonstrated outstanding and balanced participative/directive and quality leadership.
- Talent for fostering resource optimization, continuous improvement, and operational efficiency.
- Exceptional skills for analyzing problems and finding innovative solutions.
- Proven ability to motivate, mentor, and work efficiently, as well as with persons from other cultures, in cross-functional and self-directed work teams.
