Sr. Director Compliance, NA & LATAM

Sr. Director Compliance, NA & LATAM

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 Quality Compliance & Excellence

位置：

North America, United States, Pennsylvania, Fort Washington

工作地点：

混合

你会做什么

Kenvue is currently recruiting for:

Senior Director Regulatory Compliance, NA & LATAM

Role reports to: Head of Quality, Compliance & Performance

Location: Fort Washington, PA

Travel %: May require up to 25% travel, with higher peaks depending on issues and urgent support needs.

What you will do

The Sr. Director Regulatory Compliance, NA & LATAM, is responsible for managing and directing the North America, LATAM, and External Manufacturing compliance team members to create and execute the strategy for obtaining sustainable compliance and supporting end-to-end Quality System management across the multiple business units in North America and LATAM, as well as External Manufacturing groups.
 

This role provides leadership for development, deployment and maintenance of strategic regulatory and quality requirements within North America and LATAM.  Lead the core activities of expert cGMP compliance support for sites, while continuing to work closely with other compliance teams, Quality Assurance, and process owners within assigned regions.  Will also work closely with key quality, regulatory affairs, supply chain, R&D and compliance partners within the Supply Chain global network, particularly in areas of interest regarding regulatory requirements. 

Key Responsibilities

• Collaborates with the Global Q&C Leadership team members (Make, Source, Commercial Quality and/or Quality Systems) in establishing short- and long-term strategic goals and directs implementation to achieve compliance and business objectives.  Participates in and provides inputs to Global management reviews and ensures Site level management reviews are covered by reporting staff.

• Provides support for Q&C initiatives that impact quality and compliance systems, and in partnership with Make and Commercial Quality leadership will develop plans and coordinate resources to support deployment.

• Drives effective business strategies to ensure proactive regulatory compliance programs and projects are standardized and aligned with regulatory requirements, and company standards. 

• Provides measurable input into the development and implementation of Regulatory Compliance processes, standards, or plans in support of the organization’s strategies, with focus on health authority management and readiness, internal audits, regulatory intelligence and Regulatory Compliance processes. 

• Drives the strategy to monitor the implementation and sustainability for compliance remediation projects within assigned regions and functions, as needed.  Assures the development and execution of audit plans and provides for the periodic assessment of the overall compliance with the business unit remediation efforts. Monitors quality related data, trends and overall program for sustainability.

• Exercises a high level of independent judgement and execution in anticipating, interpreting, evaluating and resolving complex organizational opportunities while appreciating the direct impact on the operational results of the business.  These decisions impact the portfolio and help shape long-term strategies.

• Provides overall management of the Regulatory Compliance staff (direct reports) development and establishes learning initiatives and training of staff in current and emerging regulatory compliance and related requirements.

• Assure the timely execution of the Regulatory Compliance common processes for Independent Audit and Follow-up (CAPA implementation), as well as Recovery. 

*This is not an exhaustive or comprehensive listing of job functions.  May perform other duties as assigned.

What we are looking for:

Required Qualifications

Education:

• A minimum of a Bachelor’s degree is required, an advanced degree is preferred.

• Focused degree in science, engineering or equivalent is strongly preferred.

Experience:

• A minimum of 15 years of experience in a medium to large scale, matrixed Life Sciences organization is required.  A minimum of 10 years of Quality and Regulatory Compliance experience in the Pharmaceutical/OTC Drug and/or Medical Device industries is required.

• Previous experience working inside a Regulatory Agency/Board of Health (i.e. FDA, MHRA) is strongly preferred.

Desired Qualifications

Knowledge:

• Understanding of the requirements for compliant drug, cosmetic and consumer medical device manufacturing including facilities, equipment, documentation, testing and product flow.

• Strong knowledge of quality and compliance (GMPs) in a regulated manufacturing environment.

• Knowledge of regulatory and development process (both pre-approval and post launch monitoring) and scale up.

• Thorough understanding of how regulatory bodies (boards of health) approach inspections and how to respond to issued observations.

• Working knowledge of New Drug Regulations and GxP/Quality System Regulations.

  • Preferred:

    • Experience working in global and multicultural settings.

    • Experience working with statistics, analytics and data trending.

Skills:

• Leadership Skills:

  • Strong personal leadership with demonstrated competency interfacing with senior leaders.

  • Strong ability to translate complex information for a wide range of senior leaders.

  • Demonstrated experience engaging executive leaders and establishing stakeholder relationships.

  • Experience managing people.

  • Strong influencing, negotiating, networking and relationship building skills.

  • Ability to create an open and inviting environment.

  • Proven track record for leading and developing others (direct reports, mentees, etc.).

  • Exceptional written and verbal communication skills.

• Technology Skills:

  • Proficient with MS Office products (WORD, EXCEL, PowerPoint, etc)

  • Advance analytical skills.

Responsibility for Others:

• This position will/may have responsibility for 3 to 5 FTEs, consisting of Directors, Sr. Managers and Managers assigned to support the businesses across assigned regions and functions.

Working Relationships / Interfaces:

• Principal Relationships Inside the Companies

  • This individual will interact with Global Executive/Senior leadership, including Make, Source, Commercial Quality and Quality Systems.

• Principal Relationships Outside the Companies

  • This individual may interact with quality professionals in third-party organizations and health authority officials, as required.  This role will have the capacity to engage in Regulatory Outreach and be connected to one of the major industry organizations for benchmarking and knowledge-sharing with regulatory bodies and industry experts.

What’s in it for you

• Annual base salary for new hires in this position ranges from $214,200 to $302,400. This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.

• Competitive Benefit Package*

• Paid Company Holidays, Paid Vacation, Volunteer Time & More!

• Learning & Development Opportunities

• Kenvuer Impact Networks

• This list could vary based on location/region

*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

对您有什么好处

$214,200.00 - $302,400.00

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。