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Process Quality and Inspection Readiness Lead - 2407018597W

Description

Quality Process and Inspection Readiness Lead

Kenvue is currently recruiting for: Quality Process and Inspection Readiness Lead to be based in Poland. This position reports to the Global Head of Performance and Compliance

Who we are At Kenvue, we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® —are category leaders trusted by millions of consumers who use our products to improve their daily lives. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes.

What You Will Do

The Associate Director, Process Quality and Inspection Readiness Lead (PQIRL) is responsible for Medical Safety preparation, coordination, logistic management, reporting, and follow-up of Regulatory Authority (RA) inspections and Marketing/Alliance Partner PV audits of relevant functional groups. The Associate Director also supports co-ordination and quality control of the audit requests pertaining to Medical Safety during internal audits of global Medical Safety functions. The Associate Director establishes when notification to senior management is appropriate and recommends where necessary required actions. As a part of the responsibility for the inspection and audit follow-up activities, the Associate Director works closely with QPPV and the Global Head of Performance and Compliance to analyze any trends in relation to findings and implementation of the robust preventative strategies.

In addition, the Associate Director is responsible for oversight of Medical Safety Quality and Compliance governance and oversight forums. Keys for success in this role include the ability to develop partnerships with Regulatory Affairs and Local Operating Company colleagues of all levels and to influence without authority. Key Responsibilities

Manage PV inspection and audit support activities including, but not limited to:

• Develop, document, and continuously apply learnings to the inspection and audit conduct activities including introduction of the automation

• Manage logistics of the relevant audits and inspections: coordinate scheduling and logistics, preparation, confirming Subject Matter Expert (SME) lists and interviewees, ensure availability of organization charts and overview presentations, managing pre and during audit/inspections requests for information. Ensure that these resources are in place also to account for unannounced RA inspections

• Where appropriate provide a sense check review of pre and during audit/inspections requests for information

• Manage PV questionnaires, surveys, and queries from Health Authorities and Marketing/Alliance Partners

• Maintain Audit/Inspection mailbox

• Maintain audit and inspection master schedule

• Prepare and communicate audit/inspection announcements

• Prepare and circulate daily updates concerning audit/inspection progress

• Ensure that end of days and close out meetings are scheduled

Analyze trends in relation to findings and implementation of the robust preventative strategies:

• Provide expertise in root-cause analysis

• Review outputs from different sources for inclusion into the PSMF, including self-identified non-conformances, temporary change controls to look for commonalities of findings and areas for system improvements

• Coordinates planning, conduct and follow-up on action items derived from PV Q&C Governance Forums and Any other duties as assigned including support of operational compliance and quality oversight functions as necessary

Qualifications

What We Are Looking For

Required Qualifications

• Minimum of bachelor’s degree in relevant discipline (Business, Science, Medical, Operations, etc.) with 8 years of pharmaceutical industry experience or advanced academic degree with 5 years of pharmaceutical industry experience.

• Minimum of 3 years of experience in PV and/or PV compliance monitoring.

• Knowledge of global PV laws and regulations.

• Requires problem solving skills to interpret data & information, analyze, and make recommendations.

• Ability to lead global work streams, drive teams to make decisions, achieve deliverables and issue resolution

• Ability to function in a global matrix environment.

• Excellent communication and writing skills.

• Understanding of and experience with multi-cultural working is preferred.

• Ability to evaluate processes and procedures against outcomes to identify methods to improve efficiency, accuracy, and compliance.

• Ability to utilize appropriate initiative and autonomy in achieving objectives.

• Experience in participation, management, or conduct of audits/inspections preferred.

• Proficiency in Microsoft Excel and SharePoint and developing and conducting presentations for different levels of management is required

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

Primary Location Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw

Job Function Drug & Product Safety Operations

Req ID: 2407018597W