Manager Customer Quality - Pharma, Biotech or Medical Device

Gerresheimer

Manager Customer Quality - Pharma, Biotech or Medical Device

Peachtree City, GA
Full Time
Paid
  • Responsibilities

    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

    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.