Global Regulatory Compliance Auditor

Ce que nous faisons

Chez Kenvue, nous réalisons le pouvoir extraordinaire des soins quotidiens. S'appuyant sur plus d'un siècle d'héritage et enraciné dans la science, nous sommes la maison de marques emblématiques - dont NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® et BAND-AID® que vous connaissez et aimez déjà. La science est notre passion ; Le soin est notre talent.

Qui nous sommes

Notre équipe mondiale est composée de ~ 22 000 personnes brillantes avec une culture d'entreprise où chaque voix compte et chaque contribution est appréciée. Nous sommes passionnés par les idées, l'innovation et l'engagement à fournir les meilleurs produits à nos clients. Avec de l'expertise et de l'empathie, être un Kenvuer signifie avoir le pouvoir d'avoir un impact sur des millions de personnes chaque jour. Nous donnons la priorité aux personnes, nous nous soucions farouchement, nous gagnons la confiance grâce à la science et nous résolvons les problèmes avec courage - et nous vous offrons de brillantes opportunités ! Joignez-vous à nous pour façonner notre avenir et le vôtre. Pour plus d'informations, cliquez sur ici.

Role relève à :

Senior Director Auditing

Lieu :

Asia Pacific, India, Maharashtra, Greater Mumbai

Lieu de travail :

Entièrement à distance

Ce que tu vas faire

Kenvue is currently recruiting for:

Global Regulatory Compliance Auditor

This position reports into Senior Director Auditing and is based at Mumbai.

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who we are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours.

Travel %: 40%

What you will do

• Execute the corporate’s Regulatory Compliance audit program by, among other duties assigned as deemed applicable, performing, and leading, audits across Internal Manufacturing (IM), External Manufacturing (EM), suppliers and others to assure audit readiness and compliance with applicable government regulations, company standards, policies, quality agreements, international standards and procedures.

• Manage the execution of audit planning, scheduling, site coordination, budget, and employee development.

• Identify, accurately capturing holistic view of potential compliance risks, documenting audit findings and promptly communicating, and as appropriate escalating issues to senior management.

• Issue and distribute, in a timely manner, audit results for review by management

• Develop and maintain effective and collaborative business relationship with key stakeholders and functional department within J&J to ensure that the strategic objectives of the corporate audit program are achieved and continuously improving execution and results based on process insights.

• Maintain current on regulatory requirements changes and responsible for providing recommendations for audit program improvements to effectively assess GxP compliance.

• Support the Enterprise Regulatory Outreach group to appropriately influence and interpret requirements of the Regulatory Agencies around the globe.

• Provides support to the year’s audit schedule including pre-audit planning, resourcing, scheduling and execution of audits (in-person, remote or using appropriate auditing tools) to ensure the audit program is consistently meeting the objectives of achieving a healthy state of audit readiness

• Plans audits to fit auditee’s site type, products, technology and potential linkages to other sites

• Leads and executes audits per said schedule or at the discretion of management based on risk or prioritization deemed necessary and reports via verbal and written communication any outcomes that are in the scope of the audit

• Immediately escalates significant compliance issues to management capturing description of potential violation, severity and potential impact on the company’s products, systems, processes or consumers

• Continuously improves technical and interpersonal skills, through training or otherwise, to serve as subject matter expert on Regulatory Compliance matters and help stakeholders improve awareness of potential gaps and opportunities for remediation

• While in audit, represents the audit team as an engaged partner fostering trust and collaboration to identify strengths and weaknesses, helping the auditee understand their state of compliance and allowing the process to provide the appropriate steps to remediate

• Support the preparation of metrics and performance data as appropriate, based to support identification of emerging compliance trends. This will enable providing holistic view of potential compliance risks across the company and help deploy countermeasures strategies to prevent impact and sustain state of compliance

• Supports the department effort to maintain the yearly budget

• Continuously evaluates Regulatory Compliance procedures identifying improvements based on input from the changing Regulatory requirements, emerging trends, voice of customer and audit outcomes, changes to product, technology portfolios of the company, etc.

What we are looking for

Required Qualifications - A minimum of bachelor’s degree in science, engineering, or another related field

Experience - Experience in conducting or exposure to Quality or Regulatory Compliance auditing in a global regulated healthcare environment. Experience in Quality and Regulatory Compliance. Minimum years of experience is set by department head.

Knowledge, Skills and Abilities:

• Proven ability to conduct and manage GxP audits including development of risk-based audit strategies, audit planning, execution, reporting audit findings in a concise manner.

• Strong Quality and Compliance background with deep understanding of Global Regulatory cGMP requirements.

• Working knowledge of FDA/ European guidance documents.

• Knowledge dealing with Worldwide Health Authorities inspections and their approaches and how to effectively respond to their observations.

• Computer System Validation experience.

• Strong communication skills and ability to quickly build credibility with Operations, Quality and Compliance stakeholders.

• Excellent decision making and analysis skills.

• Exceptional written and oral communication skills with individuals and groups at all levels of the company.

• Strong negotiating and influencing skills.

• Ability to identify and take in the vital points of the audit and make big picture decisions and author appropriate observations.

• Knowledge of regulatory and development process (both pre-approval and post launch monitoring) and scale up.

• Strong understanding of all requirements for compliant drug/ device/ cosmetic/ dietary supplement manufacturing, including facilities, equipment, documentation, testing, and product flow.

• Knowledge in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles/tolls and their application.

What’s in it for you

• Competitive Benefit Package*

• Paid Company Holidays, Paid Vacation, Volunteer Time & More!

• Learning & Development Opportunities

• Kenvuer Impact Networks

• This list could vary based on location/region

*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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