8 Dorchester Rd
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.
1. On time completion.
2. Regulatory and GMP Compliance
3. Robustness of program.
4. Effective metrics and reporting.
5. Training and certification compliance.
6. Values - centered execution.Requirements
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.
NONE: No hazardous or significantly unpleasant conditions. Standard office environment. Must be able to sit in front of a computer for extended periods of time.
INTENT AND FUNCTION OF JOB DESCRIPTIONS
Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected. They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions. Well-constructed job descriptions are an integral part of any effective compensation system.
All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate.
In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization.
Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.
Nice-Pak Products, Inc. (NP) is the global developer, manufacturer and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection products.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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