Quality Manager

Job Description

POSITION SUMMARY: The Quality 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for the implementation, update and improvement to the Quality Management System to achieve transformation of the site to world class performance as measured by demanding pharmaceutical customers.  Ensures that the production process and final product both meet established and anticipated 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.   Integral participation in the site leadership team to achieve performance and sustainability targets as outlined in Gerresheimer’s Formula G strategy.

• 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 to the shop floor, and timely resolve complaints.  Monitors / reports complaint status for Moulded Glass Americas and works to reduce, minimize and eliminate complaints.

• Coordinate with all departments to improve repeatability and consistent good quality in rapidly evolving high value product 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:
  • Develops and maintains a Strategic Supplier Index and effectively manages supplier risk.
  • Coordinates and approves all sample submissions of new products and initiates change control policies.
  • Oversees lab services and compliance to requirements, both inside and outside
  • Reviews, makes recommendations and approves all credit approvals for quality complaints.  Informs and notifies BU Financial Department of appropriate accrual levels
  • Oversees all activities surrounding CAPA’s and related customer interaction
  • Assists plant and company management in preparing quality related reporting and presentation materials including Operative and Strategic Plans 
  • Coordinates customer specification development, related production trials and customer audits.  Facilitates approval and sourcing of capacity from international Gerresheimer Moulded Glass facilities as needed.
  • Participates in plant management staff meetings and key strategic initiatives
  • 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.
  • Identifies training needs, recommends and assists in training of plant personnel in other targeted areas, as needed.
  • 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

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.

 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

Additional Information

PHYSICAL DEMANDS:

Normal demand of management level employee including but not limited to: (Code: Occasional- up to 2.5 hours; Frequent – up to 5.5 hours;  Continuous – over 5.5 hours

• Standing/Walking                                          Occasional
• Lifting up to 25lbs                                          Occasional
• Twisting/Bending                                           Occasional                                
• Stair Climbing                                               Frequent
• Manual Dexterity 100% during shift              Continuous
• Near Vision                                                   Requires accurate (20/20) vision
• Color Vision                                                  Requires minimal color discrimination
• Visual Depth
• Travel required including domestic US and/or international (approx. 5% travel)