Distribution Center QA Lead-Palmetto, Georgia

Distribution Center QA Lead-Palmetto, Georgia - ~~~W

Description

Kenvue is currently recruiting for

Distribution Center QA Lead

This position reports to Senior Manager Distribution and Supplier Quality CQ and is based in Palmetto, Georgia

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: Senior Manager Distribution and Supplier Quality CQ

Location: Palmetto, Georgia

Travel %: 25%

What you will do

The Distribution Center QA Lead is responsible for supporting the Quality and Regulatory Compliance function for Commercial Quality on behalf of Kenvue Consumer Health. Specifically, this position, coordinates and implements quality compliance programs related to the storage, handling, and distribution of a broad portfolio of products including devices, drugs, cosmetics, and consumer goods with focus on being the quality voice for the DC operations. This position supports the Distribution organization with external and internal regulatory audits such as FDA, DEA, etc.

Taking direction from Commercial Quality Leadership to execute the Quality Strategic Objectives and implements the overall company strategy. The DC QA will support and influence to represent quality with action and decisions involving audits, escalations, field actions or other significant quality events. Assures compliance to appropriate processes, controls, training, and qualifications followed to ensure a sound compliance profile for the U.S. Consumer DC network in support of current and future business needs. The DC QA will drive processes and systems to ensure that appropriate interfaces are in place end-to-end with Supply Chain and the Marketing Companies to which Deliver provides services.

Key Responsibilities

• Oversees Distribution Centers' daily issues/inquires and the 3PL sites for all products.

• Supports key strategies (tactics, projects, goals, and objectives, etc.) and related measures/metrics necessary to deliver on the Commercial Quality business, compliance, and values goals.

• Executes the tactics, projects and goals and objectives across the Quality Systems and Quality Compliance, to ensure delivery against the strategies and measures.

• Ensure quality systems are well integrated into the business in critical areas for control including product receipt, storage, handling, transportation, supplier control, non-conformance management, change management, document/records management, validation, and training.

• Support Returns processing, DC month end processes, new product introductions, monthly audits at the DC, product dispositioning and other required duties.

• Advises management on changes to corporate and government requirements. Provides guidance to organization in interpreting and implementing changes. Provides input into emerging internal and external requirements on behalf of Commercial Quality.

• Interfaces and builds partnerships with source companies, Marketing companies and third-party suppliers. Drives consistent processes and requirements through the establishment of efficient and compliant SOPs across all Partner companies and 3PLs

• Gathers metrics and data needed for the Quality System Management Review regarding the compliance status and performance of Deliver.

• Supports regulatory inspections (both internal and external) via preparation, participation, response writing and implementing corrective actions as appropriate to ensure Quality and Compliance of the Consumer DC.

• Provides Quality input and support to the Distribution training processes.

• Follow all company guidelines related to Quality and Regulatory Compliance and that all resources needed to do so are available.

• Responsible for supporting the Escalation of issues as per Kenvue Standards

• Drives quality aspects on projects, acquisitions, and divestitures.

• Implements and executes the quality system to ensure adherence to Good Manufacturing/Distribution Practices.

• Oversees the Quality performance of the Deliver 3rd Party Logistics provider via regular meetings, supplier audits and Quality System reviews. Tracks and provides KPIs / metrics to Deliver Operations and Commercial Quality to facilitate the review of ongoing quality performance.

• Participate in 1:1 and Team Meetings to cultivate an environment of diversity, equity, inclusion, teamwork, development, and continuous improvement.

• Coordinate audit readiness activities and facilitate administrative aspects of internal and external audits. Support effective and timely remediation of all deficiencies as appropriate.

• Complete respective activities described in Investigations, CAPA's, Escalations, Recalls and Change Control, as required.

• Acts as back-up for the Commercial Quality Manager.

Qualifications

What we are looking for

Required Qualifications

• Bachelor of Science or equivalent in Life Sciences or related field

• Minimum of 6 years of experience in the medical device and/or pharmaceutical industry

• Experience across the elements of a quality organization-quality systems (CAPA's, NC's Change Controls) regulatory, quality operations and regulatory compliance

• In depth knowledge of Health Authority regulations: Medical Device Regulation, Food & Drug Act, GMP's, Narcotic and Controlled Substances Regulations

• Experience in leading and managing regulatory agency inspections

• Experience with the distribution practices and requirements of regulated products (drugs/devices)

Preferred Qualifications

• Post graduate program in Quality is an asset

• Direct working knowledge of the business environment outside of the Quality Organization

• External supplier management experience

• Knowledge of SAP

• Knowledge of Tru Specification Lifecycle Management process

• Excellent interpersonal skills

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-New Jersey-Skillman

Other Locations NA-US-Georgia-Atlanta

Travel Yes, 25 % of the Time

Job Function Quality (Generalist)

Req ID: ~~~W