Corporate Quality Audit Manager

Recruiter
Nice-Pak Products, Inc.
Location
Montvale
Salary
Competitive
Posted
13 Oct 2019
Closes
15 Oct 2019
Job role
Audit
Contract type
Permanent
Hours
Full time
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.??

We're currently looking for a Quality Management Systems (QMS) Audit Manager in our Montvale, NJ location.

POSITION PURPOSE:

The Quality Management System (QMS) Audit Manager is responsible for and has the authority to establish, and maintain the effectiveness of the internal audit program.? This role will also lead, conduct, and support the external supplier audit program as
required.

The Audit Manager provides global management of quality system audits of facilities, products, and processes against medical device regulations and standards. The Audit Manager provides training, and guidance for the QMS Audit Team when applicable. This
role assures compliance with global quality systems regulation requirements including, but not limited to, the FDAs Quality System Regulations (21 CFR 210, 211), ISO 9001, the Health Canada Drug Regulations and the EMA Regulations.? The Audit Manager provides
leadership, and development to the audit program for the implementation of the quality system.

Ensures harmonization of company Quality Management System audits, and drives continuous improvement of Corporate Internal Audit by maintaining expert knowledge of regulations, company procedures, auditing and quality principles.

ESSENTIAL FUNCTIONS AND BASIC DUTIES:
  • Prepare and maintain the Internal Quality Audit Schedule, including preparing the audit agenda with cross functional groups, conducting audits, preparing auditing reports, following up the status of corrective actions, and closing the audits.? Ensure Internal
    Audits are conducted per the published Audit Schedule, and Internal Quality Audit files are well maintained.
  • Collaborate with subject matter experts to conduct external audits on suppliers, labs and 3rd party manufacturers as required.?
  • Plan and perform Quality Management Systems audits of departments, and functions against medical device, quality system regulations, and standards to achieve corporate compliance objectives.
  • Ensure that the response forms are initiated to address the audit findings, and communicate with management and auditee(s).
  • Determine when findings and audits are closed OR require escalation, and risk level review with the Vice President of Quality.
  • Ensure that Corrective And Preventative Actions (CAPAs) generated by internal audit findings are audited for effectiveness as supporting audit evidence, where applicable, and that such audits are documented.
  • Monitor, and report the effectiveness of audits including corrective action plans, effectiveness checks, and risks.
  • Provide support in the development, and monitoring of the effectiveness of the Quality Management System throughout the organization including measurement, analysis and trending of policy and objectives implementation, identification of continuous improvement
    opportunities, training and management review.
  • Assist in site audit readiness activities, and provide support during customer and regulatory body audits.
  • Assist with writing and review of procedures and instructions for development of the Quality Management System as required.
  • Develop, and maintain a Certification/Qualification program for internal auditors.
  • Interface with Site Audit Leads to evaluate, and implement Global Best Practices.
  • Participates and provides feedback into Management Reviews, and other QA related meetings.
  • Consistently demonstrates good judgment and critical thinking in the performance of Compliance activities.
DATA ENTRY & INTEGRITY:
  • Prepare, and maintain the Internal Quality Audit Schedule, including assignment of auditors if applicable, conducting audits, follow up the status of findings, writing and review report, and audit closure.
  • Lead and manage external supplier audits as required.
REPORTING & ANALYSIS:
  • Management Review, Internal Audit Team (IAT), and Quality Review Committee (QRC) matric reporting
  • Monthly Analysis and scheduling
CLIENT ENGAGEMENT:
  • Audit Remediation
  • Fair Presentation with cross functional auditee
TECHNICAL EXPERTISE:
  • Maintenance of standards including statutory and regulatory law (i.e. GMP, ISO, and local government).
  • Requirements not specified by the customer, but still needed.
SPECIAL PROJECTS:
  • Audit Remediation
  • Third party Audit support
PERFORMANCE MEASUREMENTS:
  • On time completion
  • Robustness of program
  • Training and certification compliance
  • Values centered execution
Requirements

QUALIFICATIONS:

EDUCATION/CERTIFICATION:
  • Bachelor?s Degree in a discipline that is relevant to QA
  • Exposure to Quality Management Systems, processes and procedural internal or Supplier audits to 21 CFR Part 210, 211, ISO 9001, and other applicable standards to ensure corporate and regulatory compliance
REQUIRED KNOWLEDGE:
  • Proficiency in Microsoft Office Suite, SmartSolve and Master Control modules is preferred.
EXPERIENCE REQUIRED:
  • Lead Auditor certification preferred.
  • Over 5 years of experience implementing, interpreting, and providing guidance on domestic and international regulations for drug products: FDA 21CFR210, 211, ISO 9001 standards, etc.
  • Must have experience with international regulations for medical devices.
  • Must have medical device experience, knowledge of Pharmaceutical Regulations desired.
  • Certified Quality Auditor/ISO lead Auditor Certified to conduct Quality System audits against standards and regulations such as 21CFR210, 211 and ISO 9001.
Up to 60% travel
SKILLS/ABILITIES:
  • Excellent interpersonal and communication skills; ability to work in cross–functional teams.
  • Strong analytical skills in order to analyze processes and provide solutions.
  • Flexibility to work in a high paced environment with strong prioritization skills.
  • Exhibits a high degree of integrity, initiative and motivation.
  • Knowledge of statistical methods and sampling techniques
WORKING CONDITIONS:
  • NONE:? No hazardous or significantly unpleasant conditions.
  • 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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