Compliance Specialist II

Job Description

Kenvue is currently recruiting for-

Compliance Specialist II

This position reports to Compliance Manager and is based at Fort Washington PA

Who We Are

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® Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, 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 the life of 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. For more information, click here .

Role reports to- Compliance Manager

Location- Fort Washington PA

Travel %- none

What You Will Do

The The Compliance Specialist II is responsible for-

Leader for internal audit teams and may participate in audits/inspections for third party suppliers on behalf of Kenvue Quality. This person ensures compliance to FDA and other worldwide health authority regulations/guidelines, site SOPs, study protocols, and industry standards, as applicable. This position informs department and senior management, provides recommendations for corrective action and tracks corrective action commitments until closure. The Compliance Auditor identifies areas for process and other quality improvements. The incumbent will also be responsible for other responsibilities within the Compliance department as needed.

Interfaces with management and leadership teams across Kenvue sites to achieve harmonization and standardization of practices and policies in order to improve core process reliability and efficiency. This individual also identifies deficiencies and areas for improvement and coordinates with stakeholders to strategize those remediation methods and timelines to complete commitments

Key Responsibilities

Internal Auditing-

• The persons shall be responsible for all phases of the Internal Audit Program and have the authority and responsibility to make decisions regarding the conduct of the audit and any audit observations.
• Review of applicable quality system documentation.
• Preparing the audit plan, working documents and briefing the audit team.
• Review of applicable quality system documentation
• Review of audit findings to determine if they represent conformities or nonconformities.
• Provide communication of observations to auditee as soon as possible after they are identified.
• Preparing and presenting the audit results clearly and conclusively.
• Documenting and submitting the audit report to those responsible for the matters being audited in a timely manner.
• Verify that corrective actions have been taken and are effective.
• Determines the classification for audit observations.
• Interface with Board of Health, personnel, Corporate and Sector auditors on an as [1] needed basis to represent the process. Conduct system audits and walk-through inspections as assigned.
  
  

Ensure quality and compliance in all my actions by-

• Attend GMP training on the schedule designated for my role and as appropriate for my role
• Adhere to strict compliance with procedures applicable to my role.
• Exercise the highest level of integrity in the tasks that I perform
• In a timely and prompt manner, identify report and seek correction for deviations noted in my workplace.
• Embrace a behavior of employee involvement and commitment to doing the job right the first time.
  
  

Additional Responsibilities-

• May be required to participate in cross functional teams providing Quality support as needed.
• Provide support to other functions within the Compliance group.
• Provide support to multisite teams and meetings.
• Perform other related duties as required
  
  

Required Qualifications

• A minimum of a Bachelor's degree is required, Science background preferred
• 2-4 years of experience in a Pharmaceutical GMP environment, in a quality and/or compliance position is required.
  
  

Desired Qualifications

• GMP auditing experience preferred
• Must have the capability to interpret regulatory requirements in the light of current guidance and FDA/international regulatory body field activity (regulations change day by day, issues that FDA posts for review.)
• Demonstrated ability to manage an internal audit oversight program. Interact effectively with a diverse group of individuals .
• Work independently on complex issues; serving as a subject matter / technical expert within the functional area. Ability to lead cross functional teams and facilitate discussions.
• MS Office Tools knowledge required. Excellent analytical, prioritization, communication, and strong leadership skills. Ability to work independently with minimal supervision.
• Strong GMP knowledge with proficiency in interpreting and applying GMPs to Over the Counter environment.
• Ability to conduct projects with well-defined scope in own discipline.
• Strategic view of project issues in a Quality Systems environment.
• Ability to communicate effectively with various levels (technical through senior management); excellent written and verbal communication skills.
• Ability to lead in matrix-management environment including cross-functional influence skills.
• Thorough understanding of applicable regulations/guidelines to facilitate the interpretation and impact of findings for internal and external audits.
• Ability to facilitate the interpretation and assess the impact of findings for internal audits and refer to applicable regulations/guidelines.
• GMP Auditor certification from recognized pharmaceutical organization preferred
  
  

What’s In It For You

• Competitive Total Rewards Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Employee Resource Groups
• 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 business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

Primary Location

NA-US-Pennsylvania-Fort Washington

Travel

No

Job Function

Quality Assurance

Job Qualifications

What we are looking for