Job Details

Requisition Number 18-0354
Post Date 12/5/2018
Title Manager, R&D Quality
City Montvale
State NJ
Description 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!

POSITION PURPOSE

This position is responsible for the overall quality practices and direction of the R&D team to produce excellence in execution and risk mitigation. The incumbent will be responsible for creating processes and linkage to other cross functional teams that allows the smooth progression of projects through PDI’s stage gate procedure.

RESPONSIBILITIES

• Provides quality system methodology guidance, support and review for FDA, EPA and non-regulated products throughout the design, development and change control processes.
• Actively participates on cross-functional design teams assessing design documentation for quality characteristics, including: product requirements, safety risk management, design verification, design validation, manufacturability, biocompatibility, sterilization and packaging.
• Serves as a technical resource for problem investigations to guide root cause analysis / corrective action development.
• Ensures that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation and other applicable standards.
• Leads safety and compliance within R&D. Interfacing directly with corporate QA and EH&S.
• Leads continuous improvement efforts toward data integrity and research processes. Implements a regular cadence of compliance audits within R&D laboratories.
• Reviews design history files for traceability, cohesion and risks.
• Takes an active role in providing solutions to remediate previously identified gaps
• Owner of R&D lead CAPAs
• Analysis, trending and presentation of quality metrics

PERFORMANCE MEASUREMENTS

• Ability to work in partnership with the product development, corporate quality and regulatory functions.
• Support work stream timelines and be able to balance priorities according to stakeholder needs.
• Take ownership for assigned projects and self-lead initiatives.
• Create a working environment of safety and compliance.
• Streamline existing processes to reduce redundancy and demonstrate efficiencies.
• Propose and foster new processes that further enhance R&D efficiency and reduce project risks.
• Coach others in the use of quality tools.
Requirements QUALIFICATIONS

EDUCATION/CERTIFICATION:
• University Degree in a Scientific Discipline required
• Masters an advantage
• Kaizen/Six Sigma Green Belt an advantage

REQUIRED KNOWLEDGE:
• Proven expertise with interpreting, applying, and leading others in compliance with 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, ICH Q9 Guidance for Industry – Quality Risk Management
• Experience interacting with regulatory agencies and notified bodies.
• Good knowledge and experience with corrective action and preventive action system, statistical process control, quality risk management, FMEA, DOE and other key tools for managing quality performance.
• Knowledge of medical device biocompatibility and engineering change management an advantage

EXPERIENCE REQUIRED:
• 7+ years of working experience in either pharmaceutical, medical device or FMCG industries.

SKILLS/ABILITIES:
• Excellent communication skills (verbal / written).
• High influencing skills.
• Prudent risk taker.
• Can operate with ambiguity.
• Able to work on multiple projects of varying complexity.
• Able to influence cross-functional partners to gain support and alignment to ideas.
• Computer literate (Outlook / Word / Excel).


WORKING CONDITIONS

NONE: About 5% Lab, 5% Manufacturing and 90% office environment


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.
  • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
  • Please view Equal Employment Opportunity Posters provided by OFCCP here.
  • The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
  • Please refer to the Company’s Substance Abuse Policy which protects the safety and well-being of all associates and potential associates.
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