Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 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!
The purpose of the Manager, Quality Systems, is to ensure Enterprise-wide Quality and Regulatory compliance through implementation and maintenance of robust electronic quality systems and processes. This includes, but is not limited to: System ownership of the Electronic Quality Management system (QMS), Process ownership of interrelated Quality System Elements (QSEs) and processes, including Regulated Documents, Consumer Quality (Product Complaints), and Enterprise GXP Training Qualification and CAPAs.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
DEPARTMENT/PEOPLE MANAGEMENT: 25%
1. Lead the development and implementation of Quality Systems and processes in accordance with Corporate Quality Objectives and in collaboration with team.
2. Manage the daily activities of responsible functional areas, including Document Control, and Corporate Training. This includes work assignments, schedule management, document distribution, delegation, coaching, and guidance.
3. Work collaboratively with direct reports to establish individual goals to align with organizational goals.
4. Conduct performance reviews, coaching, and guidance as appropriate.
5. Maintain all departmental procedures and processes.
6. Evaluate compliance with program through self-assessments, audits, inspections, investigations, and correction action activities as established through QRC and other Continuous Improvement activities.
7. Ensure that all issues associated with Regulated and registered products are properly managed, and data are provided to appropriate departments for internal use and for Federal and State filings.
SYSTEM MANAGEMENT: 35 %
1. Route, review, approve, obsolete, and archive controlled documentation, for all applicable areas of the QMS. Change Control, Customer Complaints, Training, CAPAs
2. Manage the periodic review process.
3. Maintain all system documentation, including, but not limited to validation documentation, design documents, and vendor payment documentation.
4. Point of contact for system inquiries during audits and regulatory inspections.
5. Ensure the e system and software are validated and consistently upgraded to the latest version in the technology.
6. Maintain the big picture of the system Enterprise and promote systems upgrades as required
1. Train direct reports on their job roles and responsibilities.
2. Train organization on the functionality of the system.
3. Maintain all system training documentation.
REPORTING & ANALYSIS: 15%
1. Create monthly trending reports and metrics for management review and Continuous Improvement.
2. Actively participate in management teams, including, Quality Review Committee (QRC), Quality/Regulatory Management Team (QRMT), and others as appropriate.
3. Deliver departmental metrics as requested.
4. Analyze monthly reports and make recommendations to ensure department is running efficiently.
AUDITS, INSPECTIONS, AND COMMITMENTS: 15%
1. Lead the organization and execution of audits and inspections, including personnel, requests, documentation, and process flow.
2. Ensure accurate, thorough, and on-time completion of all Agency and Third-Party Commitments.
3. Maintain documentation and records in accordance with regulations and internal policies.
EDUCATION/CERTIFICATION: B.S. or B.A. degree in a scientific discipline with 5+ years combined developing and managing cGMP quality systems. Advanced degree preferred.
REQUIRED KNOWLEDGE: Proficiency in Microsoft Office Suite, Internet Browsers, and Adobe PDF applications.
EXPERIENCE REQUIRED: A minimum of 5 years in a GMP Quality role, with a minimum of 4 years directly supervising personnel and/ or projects.
SKILLS/ABILITIES: Expert knowledge of the GMP Quality System in accordance with FDA regulations and ISO Standards. Strong people management skills are required; must be able to train, coach and motivate direct reports to effect a culture of Quality and compliance. Experience conducting and managing Audits and Inspections required. Ability to meet needs of Enterprise by effective prioritization and task balancing. Strong written and verbal communication skills with all organizational levels and external partners. Ability to troubleshoot complex problems. Previous system migration knowledge, including validation, is a plus.
This position is located in Orangeburg, NY in Rockland County and does not provide relocation.
To read further details or apply directly: https://bit.ly/2LL3uGv
Healthcare benefits starting on Day 1, 401k, base & bonus, and many other benefits!
Nicepak Products Inc./ PDI