Manager, Quality Validation

Manager, Quality Validation

我们做什么

在 Kenvue，我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础，植根于科学，是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。

我们是谁

我们的全球团队由 ~ 22,000 名才华横溢的员工组成，他们的职场文化中，每个声音都很重要，每一个贡献都受到赞赏。 我们热衷于洞察， 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心，成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本，热切关怀，以科学赢得信任，以勇气解决——有绝佳的机会等着您！加入我们，塑造我们和您的未来。有关更多信息，请单击 here.

Role reports to：

Site Quality Director

位置：

North America, United States, Pennsylvania, Fort Washington

工作地点：

完全现场

你会做什么

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

对您有什么好处

$124,100.00 - $175,200.00

这考虑了许多因素，包括工作地点、候选人的技能、经验、教育水平和其他与工作相关的因素

Kenvue 很自豪能成为一个机会均等的雇主。所有合格的申请人都将根据业绩获得就业考虑，不分种族、肤色、宗教、性别、性取向、性别认同、年龄、国籍或受保护的退伍军人身份，并且不会因残疾而受到歧视。