Jobs at Gerresheimer

Quality Manager

91 West Forest Grove Road, United States | Vineland | Full-time

Job Description

The Quality Systems Manager is to conduct all departmental activities such that operations are able to supply the Global Pharmaceutical industry with a quality package delivered on time at a reasonable cost. This includes correspondence and communications internally and externally directly with customers. Reports to the VP of Quality with dotted line responsibility to the Plant Manager for reporting and resolution of quality concerns.  Is responsible for the implementation and maintaining of a system to ensure that all products manufactured by the organization meet customer specifications and achieve superior quality and reliability levels.  Directly supervises Quality Specialists, Quality Engineers, and Quality Supervisor.  Indirectly responsible for hourly QC and QA personnel.

•       Responsible for the implementation, update and improvement to the Quality Management System to ensure the program continues to be suitable and effective.  Ensures that the production process and final product both meet established and changing customer requirements and quality standards such as ISO 9001:2015, FDA Regulations, GMP, and other relevant standards. 

•       Transform stated Gerresheimer Quality Strategies and Objectives into a sustainable Quality Assurance Process.  Formulate and maintain Quality objectives and coordinate those objectives in cooperation with other department managers to maximize quality, reliability and to minimize costs

•       Interaction with customers, understanding their quality requirements, working with Commercial Account Executives and Field Quality Engineers.  High degree of customer visitation as required to engage in Quality meetings to identify opportunities to improve customer satisfaction and service as it relates to Quality

•       Coordinate investigation for all customer complaints and articulate customer concerns to the internal QA, QC, and Operations Teams.  Effectively and efficiently, prepare comprehensive responses to customer complaints and concerns.  Work directly with Operations and SMEs to set expectations, drive accountability, and timely resolve complaints.  Monitors / reports complaint status for TGA and works to reduce, minimize and eliminate complaints.

•       Coordinate with all departments to improve repeatability and consistent good quality in the manufacturing processes.   Evaluate and insist on solutions that eliminate repetitive Quality complaints and result in achieving and sustaining dimensional and cosmetic AQLs to meet customer standards.

•       Responsible for the management of a team that:

o    Develops and maintains a Strategic Supplier Index and effectively manages supplier risk.

o    Coordinates and approves all sample submissions of new products and initiates change control policies.

o    Oversees lab services and compliance to requirements, both inside and outside

o    Reviews, makes recommendations and approves all credit approvals for quality complaints.  Informs and notifies BU Financial Department of appropriate accrual levels

o    Oversees all activities surrounding CAPA’s and related customer interaction

o    Assists plant and company management in preparing quality related reporting and presentation materials including Operative and Strategic Plans 

o    Coordinates customer specification development, related production trials and customer audits.  Facilitates approval and sourcing of capacity from international Gerresheimer Tubular Glass facilities as needed.

o    Participates in plant management staff meetings

o    Ensure plant audits are being performed to determine the effectiveness of the quality system. Ensures that all non-conforming material, either raw material or finished goods, is handled according to established policies and procedures.

o    Identifies training needs, recommends and assists in training of plant personnel in other targeted areas, as needed.

o    Consults with all segments of management responsible for plant policies.  Ensures compliance within area of responsibility.  Makes recommendations for improving effectiveness of policies and procedures.

•       Recruit, hire, train staff, evaluate employee performance, and recommends or initiates promotions or transfers, and will initiate disciplinary actions if needed.

•       Performs other duties as assigned.

•       High degree of availability on weekends and evenings due to the operation of 24/7 plant 

 

Qualifications

QUALIFICATIONS & SKILLS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.

 

•               Well-developed management skills

•               Ability to recruit, train and motivate personnel

•               Excellent written, oral communications and interpersonal skills

•               Excellent technical writing skills

•               Strong computer competencies, Microsoft Office, SAP, Project Management

•               Ability to read and interpret technical drawings / schematics

•               Excellent administrative skills

•               Strong problem solving skills

•               Ability to learn new process and technologies

•               Strong project management skills and organizational skills

•               Able to handle pressure and demands of fast-paced high-volume customer facing role

 

BEHAVIORAL ATTRIBUTES:

 

•               COMMAND SKILLS

•               COMPOSURE

•               CUSTOMER FOCUS

•               TIMELY DECISION MAKING

•               DECISION QUALITY

•               DIRECTING OTHERS

•               INFORMING

•               INTEGRITY AND TRUST

•               INTERPERSONAL SAVVY

•               LISTENING

•               MANAGERIAL COURAGE

•               PERSEVERANCE

•               PLANNING

•               PRIORITY SETTINGS

•               PROCESS MANAGEMENT

•               MANAGING THROUGH SYSTEMS

•               WRITTEN COMMUNICATION

Additional Information

EDUCATION/EXPERIENCE:

•       Bachelors’ Degree required; STEM degree preferred.  Preferred additional certifications in (CQE, CQM, CQA), Auditing, Six Sigma, or other. 

•       10 years experience in Quality, with minimum 5 in a supervisory role

•       Prior experience with complex manufacturing processes with multiple variables affecting quality.  Glass industry background helpful; familiarity with pharmaceutical compliance practices desired.

•       Strong background in ISO-9000 and other similar quality system and regulatory requirements, cGMP experience preferred.

Company Description

Gerresheimer is the global partner for pharma, biotech, healthcare and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging and drug delivery devices. 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, focus on quality and customers. 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 10,000 employees and generates annual sales of more than €1.4 billion. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.

Equal rights

All applicants are considered without any regard to race, color, creed, religion, age, national origin, ancestry, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status or membership, or any other legally protected status.

Interested? Apply today!

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