Manager, Quality Validation

Manager, Quality Validation

Lo que hacemos

En Kenvue, nos damos cuenta del extraordinario poder del cuidado diario. Sobre la base de más de un siglo de herencia y arraigados en la ciencia, somos el hogar de marcas icónicas, incluidas NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® y BAND-AID® que ya conoces y amas. La ciencia es nuestra pasión; El cuidado es nuestro talento.

Quiénes somos

Nuestro equipo global está formado por ~ 22.000 personas brillantes con una cultura laboral en la que cada voz importa y cada contribución es apreciada. Nos apasionan las ideas, innovación y comprometidos con la entrega de los mejores productos a nuestros clientes. Con experiencia y empatía, ser un Kenvuer significa tener el poder de impactar a millones de personas todos los días. Ponemos a las personas en primer lugar, nos preocupamos ferozmente, nos ganamos la confianza de la ciencia y resolvemos con coraje, ¡y tenemos oportunidades brillantes esperándote! Únase a nosotros para dar forma a nuestro futuro y al suyo. Para obtener más información, haga clic en aquí.

Role reports to:

Site Quality Director

Location:

North America, United States, Pennsylvania, Fort Washington

Lugar de trabajo:

Totalmente in situ

What will you

The Manager, QA Validation is responsible for managing daily operations of the QA validation department, designing and developing validation policies and procedures, and ensuring continuous improvement in line with regulatory requirements:

Key Responsibilities

• Lead a team of QA professionals to ensure compliance with industry standards for Commissioning & Qualification (C&Q), cleaning validation, manufacturing process qualification, packaging line trials (PLT) process performance validation (PPQ), and computer system validation (CSV)
• Collaborate with cross-functional teams to achieve site and company objectives
• Lead cross-functional teams to drive continuous improvement in validation processes and strategies, as necessary
• Stay updated on industry trends and regulatory requirements to provide expert guidance on validation activities
• Collaborate with senior management to address critical business issues and identify growth opportunities
• Ensure strict adherence to Health, Safety, and Environmental guidelines in all validation practices
• Represent FWP QA at VRC and TRF
• Provide quality support and oversight to the criticality assessment process
• Support New Product Introduction (NPI), Technical Transfer (TT) and continuous improvement projects
• Support in house deviation processes, providing insights and validation input.
• Interact with Regulatory Health Authority representatives during inspections as an SME.  Support responses to Regulatory Health Authorities.
• Responsible for accurate preparation, review and approval of protocols and reports.
• Responsible for ensuring adherence to protocol sampling plans
• Responsible for collecting and providing required APR/PQR quality attribute data and analysis of the data
• QA Validation SME with responsibility for understanding the critical aspect of products, components and labeling requirements.
• Must understand product familiies, product size and put-up and product characteristics associated with active ingredients and excipients.  Must understand the link between Critical Quality Attributes (CQAs) and Critical Processing Parameters (CPPs)
• Coordinate with regional and global teams to standardize the validation process and communicate trends in audit findings and actions

What we are looking for

Required Qualifications

• Bachelors Degree in Engineering, Chemistry, Microbiology or a related field
• Minimum 8-10 years of experience in quality validation, preferably within the drug industry
• Strong leadership skills with the ability to mentor and motivate team members
• In-depth knowledge of regulatory requirements and quality standards, especially in the areas of equipment commissioning and qualification, cleaning validation, computer system validation, and process performance qualification
• Strong organization skills and ability to manage multiple competing priorities

Desired Qualifications

• Proven track record of leading key enabling functions
• Exceptional analytical skills to interpret complex business data and make informed decisions
• Ability to influence decision-making at plant leadership level
• Effective leadership in navigating ambiguity, conflict, and complexity
• Demonstrated alignment with Leadership Imperatives through behaviors and actions
• Excellent communication skills, both verbal and written

What's in it for you

$124,100.00 - $175,200.00

Esto tiene en cuenta una serie de factores que incluyen la ubicación del trabajo, las habilidades del candidato, la experiencia, el nivel de educación y otros factores relacionados con el trabajo.

Kenvue se enorgullece de ser un empleador que ofrece igualdad de oportunidades. Todos los solicitantes calificados recibirán consideración para el empleo basada en el mérito sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, edad, origen nacional o estado de veterano protegido y no serán discriminados por motivos de discapacidad.