Director of Quality Management System(QMS) Processes

Director of Quality Management System(QMS) Processes

我們做什麼

在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

我們是誰

我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.

Role reports to：

Head of Proactive Reg Comp and Standards

位置：

North America, United States, New Jersey, Summit

工作地點：

混合

你會做什麼

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

對您有什麼好處

$190,825.00 - $269,400.00

這考慮了許多因素，包括工作地點、候選人的技能、經驗、教育水準和其他與工作相關的因素

Kenvue 很自豪能成為一個機會均等的雇主。所有合格的申請人都將根據業績獲得就業考慮，不分種族、膚色、宗教、性別、性取向、性別認同、年齡、國籍或受保護的退伍軍人身份，並且不會因殘疾而受到歧視。