Senior Manager Customer Quality - Pharma, Biotech or Medical Device

Gerresheimer • Peachtree City, GA

10d

About The Position

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 product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2022 of EUR 1.8bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.Gerresheimer Peachtree City L.P. was established in 1993 in Peachtree City, GA, as part of the Plastics & Devices Division manufacturing and assembling a variety of precision molded plastic parts for various applications in the medical industry. The subsidiary operates in an 132 K sq. ft. production facility with 600
employees.
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.

Requirements

• 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.
• 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

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees