Senior Manager Customer Quality Pharma, Biotech or Medical Device

Peachtree, GA - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Department:

Quality Management

Job Summary

Technical and disciplinary management of the team with all relevant individual tasks (management and control personnel development performance management etc.)
Resource Planning for the Team
Support of QE Team members in fields of audits and meetings.
Timely processing of quality-relevant activities for customer projects within the QE Team.
Participation in the creation and improvement of internal quality standards according to regulatory or industrial standards and guidelines.
Mentoring function for QE Team members
Active participation in the goal achievement process within the GMS system.
Execution of assigned quality tasks during product realization process according to the stage gate process (Phase I IV)
Transfer of DMR including training (Phase IV) and support of the global production sites during transfer phase (Phase IV to Phase V) especially support of PQ / Process Validation stage.

Qualifications :

Very good knowledge of personnel management and leadership methods (Professional Level)
Professional Knowledge of applicable standards (e.g. ISO 13485 ISOCFR 820 ISO 14971)
Good operating experience with standard office software (SAP MS Excel MS Word MS Powerpoint) (Professional Level)
Solid knowledge of statistical / QM methods (Advanced Level)
Technical studies in the field of mechanical engineering plastics engineering medical engineering with extensive professional experience in the medical/pharmaceutical industry.
Minimum of 5 years professional experience in the field of Quality Engineering or Quality Management within a leadership role.

Additional Information :

Counseling skills and conflict management methods
Knowledge and use of leadership methods (e.g. MCCL)
Risk identification and presentation
Fluent written and spoken English (A2 / B1)
Good analytical competence; experience in systematic problem-solving Techniques (e.g. KT Six Sigma Fault-Tree Analysis)
Well established moderation and presentation techniques
Solid structured way of working

All your information will be kept confidential according to EEO guidelines.

Remote Work :

Employment Type :

Full-time

Technical and disciplinary management of the team with all relevant individual tasks (management and control personnel development performance management etc.)Resource Planning for the TeamSupport of QE Team members in fields of audits and meetings.Timely processing of quality-relevant activities fo...

Technical and disciplinary management of the team with all relevant individual tasks (management and control personnel development performance management etc.)
Resource Planning for the Team
Support of QE Team members in fields of audits and meetings.
Timely processing of quality-relevant activities for customer projects within the QE Team.
Participation in the creation and improvement of internal quality standards according to regulatory or industrial standards and guidelines.
Mentoring function for QE Team members
Active participation in the goal achievement process within the GMS system.
Execution of assigned quality tasks during product realization process according to the stage gate process (Phase I IV)
Transfer of DMR including training (Phase IV) and support of the global production sites during transfer phase (Phase IV to Phase V) especially support of PQ / Process Validation stage.

Qualifications :

Very good knowledge of personnel management and leadership methods (Professional Level)
Professional Knowledge of applicable standards (e.g. ISO 13485 ISOCFR 820 ISO 14971)
Good operating experience with standard office software (SAP MS Excel MS Word MS Powerpoint) (Professional Level)
Solid knowledge of statistical / QM methods (Advanced Level)
Technical studies in the field of mechanical engineering plastics engineering medical engineering with extensive professional experience in the medical/pharmaceutical industry.
Minimum of 5 years professional experience in the field of Quality Engineering or Quality Management within a leadership role.

Additional Information :

Counseling skills and conflict management methods
Knowledge and use of leadership methods (e.g. MCCL)
Risk identification and presentation
Fluent written and spoken English (A2 / B1)
Good analytical competence; experience in systematic problem-solving Techniques (e.g. KT Six Sigma Fault-Tree Analysis)
Well established moderation and presentation techniques
Solid structured way of working

All your information will be kept confidential according to EEO guidelines.

Remote Work :

Employment Type :

Full-time

Key Skills

Debugging
Remote Access Software
IT Service Management
IOS
Multithreading
VPN
Neo4j
FISMA
SSO
Github
Google Suite
Troubleshooting

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About Company

Gerresheimer

Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end pr ... View more

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