Manager Customer Quality - Pharma, Biotech or Medical Device at Gerresheimer

Peachtree City, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Jul, 26

Salary

0.0

Posted On

07 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Personnel management, Leadership, ISO 13485, ISO 15378, 21 CFR 820, ISO 14971, Quality engineering, Quality management, Statistical methods, Problem-solving, Six Sigma, Fault-tree analysis, Process validation, Risk identification, Project management, Mentoring

Industry

Machinery Manufacturing

Description

Company Description Gerresheimer is an innovative system and solution provider and global partner for the pharma, biotech and cosmetics industries. The company offers a comprehensive portfolio of pharmaceutical packaging, drug delivery systems, medical devices and digital solutions. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With around 13,600 employees and over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. Job Description 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, ISO 15378, 21 CFR 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.

Responsibilities

The Manager Customer Quality will provide technical and disciplinary leadership to the Quality Engineering team while overseeing resource planning and personnel development. They are responsible for ensuring quality standards are met during product realization and supporting global production sites through process validation and transfer phases.