Corporate Training and Quality Manager - FCX/PCI - Raleigh, NC

Location: 

Raleigh, NC, US, 27617

Company:  9290-FCX Performance, Inc

Join the Pharmaceutical Calibrations and Instrumentation (PCI) team! We are seeking a top-notch manager that is experienced in corporate level training development and has strong ISO17025 knowledge with the proven ability to lead by example.  Please review the job description below and apply if you would like to be considered.  If you prefer working at a fast pace, are comfortable giving direction and correction in a professional and positive way, have a passion for performing quality work, and have a strong electronics or instrumentation background, this position may be just for you!   The Corporate Training and Quality Manager reports directly to the PCI President or Director as designated by PresidentThis position is an exempt position. Twenty five percent travel is required.

 

Expectations:

 

The Corporate Training & Quality Manager resource is expected to work closely with the business unit leaders.  He/she is expected to exhibit high energy and passion relative to seeking solutions and value to our clients The Training and Quality Manager is expected to establish, maintain and drive quality standards in accordance with ISO17025 requirements and company objectives.  This individual is expected to demonstrate a strong understanding of quality systems in the Pharmaceutical and Biotechnology Industry and be a subject-matter expert concerning ISO17025 requirements and possess an in-depth understanding of project management for the service industries.  The incumbent is expected to demonstrate leadership and provide guidance to direct and indirect reports and to promote teamwork and commitment to the company’s values and mission.

 

The Training and Quality Manager is expected to be an active PCI Senior Management Team member.

 

Responsibilities:

 

  • Training
    • Ensure an effective cGXP/GDP training program is in place
    • Manage the company’s training database including System Administration and user training.
    • Approve internal training programs and provide feedback on training effectiveness.
    • Promote strategic certifications, both internal and external
    • Actively participate in mid-level management position interviewing and selection
    • Mentor and develop new Team Leads and Managers
    • Manage PCI Academy and Apprenticeship program

 

  • Quality Systems
    • Maintain and continuously improve the Quality System including the Quality Manual in accordance with ISO17025 requirements and Pharma/Biotech/Life Sciences industry expectations
    • Evaluate, document, and report progress in meeting quality objectives.
    • Manage the customer satisfaction system including feedback, complaints and providing recommendations for improvement.  Submit Customer Satisfaction Survey annually, analyze results and implement corrective actions when needed
    • Manage document control program, including periodic review and approving changes.     
    • Ensure compliance of internal validation programs including change control
    • Perform Risk Assessments to address risks and opportunities to ensure actions are proportional to the potential impact on calibration results.  Update the Risk Assessment Log
    • Provide leadership and direction to Quality Liaisons and other company resources
    • Manage Corrective Action and Preventive Action (CAPA) commitments to ensure timely completion of the outlined tasks and effectiveness. Identify and implement continuous improvement programs
    • Manage the Customer Complaint system for both product and adverse event complaints; ensuring investigations are performed on time and any notifications meet regulatory reporting requirements
    • Oversee the following programs
      • ISO17025 Accreditation program, including Proficiency Testing
      • Vendor qualification and management program
      • Calibration Standards Compliance, including conducting deviation investigations, overseeing customer notification and re-calibration and closing out Calibration Exception Reports
    • Host Customer and ISO17025 Audits
    • Develop and implement quality Key Performance Indicators (KPI’s) and compliance metrics, analyze results and use the information to make data-based decisions for continuous improvement

 

  • Project Management System
    • Ensure appropriate project related communication and systems are identified and implemented including control systems and tools
    • Assist in the continuous improvement of project management training and control programs

 

  • Audits and Investigations
    • Manage the Internal Audit program of the quality system.
    • Complete the Management Review
    • Evaluate customer audit compliance. Complete Quality Assessments and other quality related customer requests for information.
  • Safety
    •   Oversees the Safety program and committee

 

Special Skills Required:

  • Self motivated individual who exhibits a professional demeanor, and enthusiasm.
  • Proven leadership and motivational skills.  Ability and willingness to mentor resources across all teams
  • Passion for the development of others
  • High level of expertise in pharmaceutical industry standards and requirements.
  • Excellent organizational, analytical and problem solving skills.
  • In-depth understanding of project management philosophies.
  • Strong interpersonal skills with the ability to interact confidently with clients and employees.
  • Possess excellent oral and written communication skills including effective technical writing and presentation skills.
  • Strong technical understanding of PCI services and life science industry
  • Superior attention to detail.  Ability to multitask.
  • Strong computer and database skills.  Intermediate to expert level experienced with Microsoft Office products such as Excel, Word, PowerPoint, Visio and Project
  • Experience with Computerized Calibration Management Systems, such as Blue Mountain RAM, ProCal, SAP, Maximo, etc.
  • Thorough understanding of ISPE Good Practices Guides for Maintenance and Calibration programs, particularly the ISPE GAMP Risk-Based Approach to Calibration Management

 

Education & Experience Required:

 

A four-year degree in Life Sciences, Management, Engineering, or other related field (or equivalent military training) and five years of quality experience in the pharmaceutical industry, ISO17025 Accredited Metrology, experience or the equivalent combination of education and experience.  Experience in service industry, metrology systems, and project management a plus.  Experience in implementation and maintenance of company wide quality system a must.

PCI is proud to serve pharmaceutical, biotechnology, medical device, and clinical research industries nationwide by providing calibration, commissioning and consulting solutions.  At PCI, calibrations are performed by highly technical, cGMP/GLP-trained personnel who are knowledgeable in quality guidelines enforced by the FDA, EPA and ISO/IEC 17025:2017. PCI is an FCX Performance Company and a Subsidiary of Applied Industrial Technologies (NYSE: AIT); a leading industrial distributor that offers more than 6.5 million parts to serve the needs of MRO and OEM customers in virtually every industry.

Applied® provides engineering, design and systems integration for industrial and fluid power applications, as well as customized mechanical, fabricated rubber and fluid power shop services. Applied also offers storeroom services and inventory management solutions that provide added value to our customers.

We are an equal employment opportunity employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, ancestry, gender, sexual orientation, gender identity, age, disability, protected veteran status, marital status, medical condition or any other characteristic protected by law.


Nearest Major Market: Raleigh

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