R&D Deployment Q&C Principal Specialist

Kenvue is currently recruiting for a:

R&D Deployment Q&C Principal Specialist

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. For more information, click here.

Role reports to:

EH R&D Quality & Compliance EMEA Lead

Location:

Europe/Middle East/Africa, Italy, Lazio, Rome

Work Location:

Hybrid

What you will do

Kenvue is currently recruiting for:

R&D Deployment Q&C Principal Specialist

This position reports into EMEA Essential Health R&D Quality & Compliance Lead and is based in Pomezia Santa Palomba.

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®, 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. For more information, click here.

What you will do

The R&D Deployment Q&C Principal Specialist supports the administration of integrated and comprehensive quality systems and controls that are appropriate, effective, efficient, and continuously improving to ensure that R&D Deployment and Tech Ops functions are operating in full compliance with sound scientific practice, Current Good Manufacturing Practices (CGMP)and within Kenvue Policies and Standard Operating Procedures.

The R&D Deployment Q&C Principal Specialist supports the deployment and the maintenance of quality systems and controls related to GMP regulations and Kenvue policies and standards. She/He reviews and approves quality system documents change control, protocols and reports and review of investigation, CAPA.

They also review and approve quality NPD/NPI/LCM (with impact to R&D Deployment activities) project relate documentation including but not limited to protocols, process/analytical reports, method validation reports, test methods, specifications, deviations/investigations, release of R&D Deployment Human use supplies, and FFC review or audits, documentation maintenance and archival, quality inspections of product, and participating on internal assessments.

The Principal Specialist will also support the general compliance such as review and approval of standard operating procedures, batch records, packaging dossiers, Certificates of Analysis and release of study materials related to the projects. Function as an advisor providing guidance on applicable Regulations (ISO, FDA, ICH, EU, and others) pertaining to business

partners.

RESPONSIBILITIES:

Be the Quality representative for R&D Deployment Project

• Participate on R&D Deployment/TechOps project teams as the Quality representative. The Principal Specialist will work with these groups relative to GMP issues, project plans, due dates, and problem identification and resolution along with assisting in compiling documentation to release R&D/TechOps studies.
• Provide GMP development documentation review and approval of batch records (Manufacturing, Packaging, and Labeling) and related documents, including Lab, Pilot, and Trial scale batches.
• Follow up, review and approve deployment plan and/or Change control or other appropriate documentation.
• Contribute to root cause investigation, review and escalation of deviations, OOS, NC and other critical issues during projects and follow up on resulting CAPAs, support in case of field actions (linked to design or GMP R&D/TechOps issues).
• Provide Quality guidance on GMP regulatory requirements including training of R&D/TechOps personnel.
• End-to-end Q&C connection in project execution.
• Support strategic R&D Deployment/TechOps initiatives.
• Anticipate and proactively shape requirements adapted to the business needs, particularly to meet sustainability objectives.

Ensure GMP level of the operation of EMEA SH/EH R&D including Pomezia R&D Deployment site

• Participate in the deployment and implementation of GMP and Quality & Compliance processes and procedures.
• She/He is responsible for the GMP documentation maintenance, storage, and archival process, including the daily activities supporting this process.
• The specialist will support the validation master plan issuance. She/He will also provide Quality and Compliance support for qualification, validation, and decommissioning activities for lab equipment, instruments, utilities, and processes.
• Training process owner support, including GxP training process.
• Attend on a regular basis laboratory operation ensuring compliance against GMP, ISO, and applicable standards.

Responsible for Management and follow up of SH/EH EMEA R&D Deployment suppliers

• Participate in R&D Deployment supplier selection, qualification and control in a timely manner up to R&D Deployment needs.
• Back-up in managing external audit plan for R&D Deployment and implementation of the external audit plan, ensuring the implementation, monitoring and execution of the resulting action plans.
• Perform and/or participate in internal audits of GMP R&D.
• Perform and/or participate in internal assessments of R&D GMP processes and areas.
• Participate in inspection readiness activities and contribute to Corporate audits and Authorities inspections.
• Manage Intracompany QA for Pomezia Deployment Center.
• Manage Intracompany QA for EMEA manufacturing sites.

What we are looking for

Required Qualifications

• Proficiencies in English and Microsoft Office applications are required.
• Internal/Lead auditor certification – if available – will be part of job assessment
• Scientific education – min bachelors’ degree or equivalent, with remarkable experience in Pharmaceutical/Food/Cosmetic or Fast Moving Consumer Goods (FMCG) companies.
• Very knowledgeable about Good Manufacturing Practices governing various product classification types (Cosmetic, Medical
• Devices) and highly committed to quality.
• Experience in auditing internal and external sites and hosting/preparing inspections.
• Proficiencies in English and Microsoft Office applications are required.
• Core competencies
• Problem solving.
• Proactive thinking.
• Project management mindset.
• Ability to work on multiple projects/topics.
• Excellent communication, interpersonal skills and diplomacy, with ability to engage and align with diverse and dispersed organizations, seniority levels and functions.
• Flexible and persistent, with good conflict handling and negotiation skills.

What’s In It For You

• Competitive total remuneration package
• Employee Assistance Program
• Learning & Development Opportunities
• A dynamic and inclusive work environment.

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.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

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