Director of Quality Management System(QMS) Processes

Director of Quality Management System(QMS) Processes

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：

Head of Proactive Reg Comp and Standards

位置：

North America, United States, New Jersey, Summit

工作地点：

混合

你会做什么

Remote work options may be considered on a case-by-case basis and if approved by the Company.

The Director of QMS Processes is responsible for the implementation and oversight of processes defined within the Kenvue Quality Management System (QMS) and Leadership of the Quality Global Process Owners (GPOs) in alignment with Kenvue’s Global Process Ownership model.  This individual is responsible for ensuring GPOs are in place for all key Quality-managed processes, ensuring simplification and driving functional process standardization on a global scale, and also for ensuring compliance to global regulations and Kenvue OKRs.  In addition, this role will coordinate with other key functional GPO Leaders in areas such as Global and Regional Make, Global Smart Operations, Kenvue Operational Excellence, Technical Operations, and Strategic Network Management.  The Director of QMS Processes will be responsible for establishing a collaborative community of practice comprised of these E2E Global Process Owners. This role ensures a high-performing team, with a change mindset. The organization must be able to balance a rapid pace of implementing transformational change, with the requirement to ensure compliance across all countries where Kenvue operates. Collaboration with regional teams is required.

For the Quality processes, this individual is responsible for:

• Ensuring all global processes within Kenvue’s E2E GxP QMS are maintained in a state of compliance to global regulations

• Execute the Kenvue Quality System Standards strategy and implement the quality policy and standard documentation hierarchy

• Providing primary leadership for all Quality GPOs and direct management of GPOs dedicated to key Quality Process such as Investigation/CAPA, Change Control, GxP Document Management & Retention, and others as defined by business need by Quality Leadership

• These GPOs will have clearly defined responsibilities, business partners defined, and measures of success that support Kenvue OKRs

• Closely collaborates with the regional Quality Systems leaders to ensure the consistent execution of the QMS across the regions through engagement with regional teams and leaders

• Represent Quality in Kenvue E2E Teams responsible for GPOs and ensuring alignment of the Quality organization to the overall process ownership model being implemented and sustained in Kenvue

• Collaborate with digital transformation office and Quality’s digital team to ensure an ecosystem of technologies are in planned and in place, to support execution of QMS

This role will govern key global processes for Kenvue by leading and facilitating a community of practice for functional GPOs (g a Global Process Ownership (GPO) model, which identifies clear responsibility for key processes defined within the QMS. 

This Team is tasked to:

• Ensuring collective ownership, monitoring progress and updates on overall health to senior management within Quality and Kenvue Supply Chain

• Ensure that all supporting tools and IT solutions meet the needs of the QMS

• Ongoing monitoring of performance measures and ownership of structural risk identification, mitigation, and escalation as needed

• Identify opportunities for improvement to the QMS.

What we are looking for

Required Qualifications

• A minimum of a bachelor’s degree in biology, chemistry, life sciences, engineering, or related field.  Master’s or other advanced degree is preferred.

• A minimum of 10 years in pharmaceutical, medical device, cosmetics or similarly regulated field is required.

• Excellent communication and interpersonal skills to influence leaders across the organization

• Ability to rapidly synthesize information to make decisions

• Proven facilitation skills to bring together cross-functional and global groups to make decisions and come to agreement is critical

• Fluent English is required

• Advanced computer skills, including data analysis, knowledge of ERP and compliance systems, understanding how different tools and systems can work together to achieve the digitization of the QMS

• People Management experience required

• Ability to travel up to 20%

#LI-SR1

对您有什么好处

$190,825.00 - $269,400.00

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。