Manager, Quality Systems

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

The Manager, Quality Systems leads and manages the Quality Systems team, ensuring enterprise-wide regulatory compliance through robust electronic systems; Electronic Document Management System (eDMS), Electronic Quality Management System (eQMS), and Laboratory Information System (LIMS).

This role represents the Quality Organization in New Product Development (NPD), enhancing processes to providing deliverables to ensure safe, effective product design, production, and distribution.

Additionally, this role drives cGMP training, regulatory compliance, continuous improvement, and efficient document and data management.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

• Lead the development, implementation, and maintenance of the Quality Systems organization and processes in accordance with Corporate Quality Objectives and applicable standards including FDA, EPA, and Health Canada.
• Manage the daily activities of responsible functional areas and staffing needs within the areas of Document Control, Training, Master Control User Management, and LIMs support.
• Ensure effective performance of the MasterControl System (eQMS)-User Management, Training and Document Control Function, and development of new eQMS Functionality.
• Document Control Management: Oversee the document control system, ensuring timely reviews, approvals, and archiving of quality documentation
• LIMS Administration: Manage the LIMS team, ensuring seamless support and performance of laboratory data system and compliance with industry standards.
• Ensure appropriate curriculums and role-based training is set up, maintained, and optimized for all Quality Management System documentation.
• R&D Project Support: Provides Quality Strategy and guidance for new product development projects, cost reduction projects and remediation projects on raw material, in-process and final product inspection, review and guidance on new raw material introduction, supplier qualification, risk assessment (FMEA, gap analysis, impact assessment), document reviews (protocols/reports), new production trials, procedures, test methods, specifications, and manufacturing instructions.
• Ensure accurate, thorough, and on-time completion of all Agency and Third-Party Commitments.
• Serve as the point of contact for eQMS and Document Control inquiries during audits and regulatory inspections.
• Continuous Improvement: Drive quality initiatives, such as CAPA management, root cause analysis, and process optimization to enhance operational efficiency.
• Other duties as assigned.

PERFORMANCE MEASUREMENTS

• Achievement of goals/metrics.
• Regulatory and cGMP compliance.
• Continuous improvement initiatives.
• Employee engagement and competency development Attainment of established goal/metrics

QUALIFICATIONS

EDUCATION/CERTIFICATION:

• Bachelors or Masters Degree, B.S. or B.A. degree in a scientific discipline, Engineering, Quality Management, or a related field or equivalent work experience.
• Advanced degree preferred but not required
• ASQ certifications are a plus

REQUIRED KNOWLEDGE:

• cGMP, FDA, and other relevant regulations.
• eQMS functionality (Document Control, Training Management, Change Control)
• Advanced Proficiency in:
  
  
  
  • Microsoft Office Suite
  • MasterControl or similar eQMS
  
  
  
  

EXPERIENCE REQUIRED:

• 10+ years in GMP Quality roles supervising personnel/projects in an FDA-regulated industry
• Experience in one or more areas: Manufacturing, Quality Engineering, Quality Assurance, and/or Quality Systems
• Administration level management and development of electronic document management system (eDMS).
• Experience developing and implementing role-based training
• Experience supporting R&D and/or in an advanced quality engineering role
• Experience developing or enhancing eQMS functionality a plus

SKILLS/ABILITIES:

• Strong leadership, communication, and problem-solving skills
• Ability to train, coach, and drive a culture of quality and compliance
• Analytical skills for troubleshooting and data-driven decision-making
• Have a sense of urgency and apply the ability to meet needs of stakeholders by effectively prioritizing and balancing tasks of self and staff
• Capability to work independently, and cross-functionally within a team environment

WORKING CONDITIONS

• No hazardous or significantly unpleasant conditions. Standard office environment. You must be able to sit in front of a computer for extended periods of time.

SALARY RANGE

• $140,000 - $150,000 annually, plus bonus

PDI is pleased to offer a comprehensive and affordable benefits program to our associates, which includes:

• Medical & prescription drug coverage
• Dental / Vision plan
• 401(k) savings plan with company match
• Basic and supplemental life insurance
• Flexible Spending Accounts (FSAs)
• Short- and long-term disability benefits
• Health Advocacy Program / Employee Assistance Program (EAP)

Many other voluntary benefit plans such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide: Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options