Manager, Compliance

Manager, Compliance

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 :

Site Quality Director

Location :

North America, United States, Pennsylvania, Fort Washington

Lieu de travail :

Entièrement sur place

Ce que tu vas faire

The Manager, Compliance is responsible for continuous improvement of site cGMP compliance. Responsible for assuring competitive compliance with current GMP enforcement, while aligning strategically with company quality/compliance initiatives. Provides compliance consulting to the process, ensuring that Plant operations consistently meet the requirements of cGMP's. Ensures that appropriate control systems are in place and continually optimized to meet changing regulatory, corporate and industry standards. Engages upper Plant Management to appropriately prioritize and put compliance improvements in place. Manages staff to prepare for, coordinate and host regulatory and corporate audits as well as manage audit responses and follow-ups. Management of the complaint system and support to the company complaint process. Provides compliance training opportunities for the Plant, interfaces with Regulatory Affairs and Home Office Compliance as needed, and manages the Site Quality Management Review Process including monitoring and interpretation of metrics and compliance risks. May be responsible for review and approval of investigations, change controls, notifications to management and other quality system documentation as needed.

Key Responsibilities:

Ensure quality and compliance in all my actions by:

• All employees
  • 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.
• People Managers
  • Ensure employees under your scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year.
  • Promote an environment of employee involvement in the workplace.
  • Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.
     

Compliance Focus:

• Provide compliance consulting to the process, ensuring that site operations consistently meet the requirements of cGMP’s. Ensure that appropriate control systems are in place and continually optimized to meet changing regulatory, corporate and industry standards.
• Manages site forums for continuous improvement –coordination/facilitation of meetings.
• Engagement of upper Management to appropriately prioritize and put compliance improvements in place.
• Preparation, coordination and hosting of regulatory and corporate audits for the site. Coordinate audit responses and follow-ups.
• Provision of compliance training opportunities for the site as needed.
• Manages the site quality management review program including monitoring and interpretation of metrics and compliance risks.
• Manages the site’s Internal Auditing program.
• Oversee the site’s Complaints program and complaint investigations.
• Oversee the site’s Supplier Quality process.
• Escalates issues as required to Home Office compliance and tracks follow ups/resolution.
• Oversee the site’s Retention sample program.
• Responsible for managing the site’s Inspection Readiness Program, including regulatory agency preparedness and pre-approval inspection readiness.
• Ensures coordination with other NA Kenvue Make sites and publication of the annual schedule of internal audits.
• Participates and provides support for the Global Notification to Management process.
• Develops and manages the Compliance budget.
   

People and Organization Focus:

• Provide direction and mentoring to supervisory and lower-level quality professionals in meeting their tactical and strategic initiatives – focusing upon the support of ongoing base business, new product/process introductions and system improvements – in a compliant, cost-competitive manner. Ensure that performance appraisals are routinely conducted, with development and succession plans in place.
• Provide compliance support in project meetings as needed.
   

Sharing Knowledge:

• Mentor site leadership on cGMP interpretation, application and current enforcement. Promote partnerships with company sites and Compliance teams.

Required Qualifications

• Bachelor's degree in Chemistry, Microbiology, Biology, Natural Science or equivalent combination of experience
• Minimum of 8-10 years of professional experience with at least 2 years of supervisory experience
• Demonstrated experience with key leadership and decision-making positions
• The ability to determine the need for process interruption
• Strong organizational skills/facilitation skills
• Fluent knowledge of cGMP regulations and guidelines, as well as the ability to interpret requirements
• Demonstrated experience managing and/or supporting Board of Health inspections including Prior-Approval inspections
• Strong verbal, written and presentation skills
• Strong skills in partnering and influencing
• Excellent communication and leadership skills

Desired Qualifications

• Knowledge of regulations and requirements for procuring, storing, manufacturing, and handling listed chemicals and controlled substances
• Previous experience interpreting the regulations and laws governing the procurement, storage, manufacture and handling of listed chemicals and controlled substances
• Experience in preparing for inspections by the US Drug Enforcement Agency
• Experience in hosting and managing inspections by the US Drug Enforcement Agency

Qu'est-ce que vous y gagnez

$124,100.00 - $175,200.00

Cela prend en compte un certain nombre de facteurs, notamment le lieu de travail, les compétences du candidat, son expérience, son niveau d'éducation et autres facteurs liés à l'emploi.

Kenvue est fier d'être un employeur souscrivant au principe de l'égalité d'accès à l'emploi. Tous les candidats qualifiés seront pris en considération pour un emploi basé sur le mérite, sans égard à la race, la couleur, la religion, le sexe, l'orientation sexuelle, l'identité de genre, l'âge, l'origine nationale ou le statut d'ancien combattant protégé et ne seront pas discriminés sur la base du handicap.