Sr. Director Compliance, NA & LATAM

Sr. Director Compliance, NA & LATAM

私たちがしていること

Kenvueで、日常のケアの並外れた力を実感します。100年以上にわたる伝統を基盤に、科学に根ざした当ホテルは、ニュートロジーナ®、アヴェーノ®、タイレノール®、リステリン®、ジョンソンズ®、バンドエイド®など、すでにお馴染みのアイコニックなブランドを展開しています。科学は私たちの情熱です。ケアは私たちの才能です.

Who We Are

私たちのグローバルチームは~22,000人の優秀な人々で、すべての声が重要で、すべての貢献が評価される職場文化を持っています。 私たちは洞察に情熱を注いでいます。 革新とお客様に最高の製品を提供することに取り組んでいます。専門知識と共感力を持つKenvuerであることは、毎日何百万人もの人々に影響を与える力を持つことを意味します。私たちは人を第一に考え、熱心に気を配り、科学で信頼を勝ち取り、勇気を持って解決します。そして、素晴らしい機会があなたを待っています!私たちと一緒に、私たちの、そしてあなたの未来を形作りましょう。詳細についてはをクリックしてくださいhere.

Role reports to:

Head of Quality Compliance & Excellence

Location:

North America, United States, Pennsylvania, Fort Washington

勤務地:

ハイブリッド

あなたがすること

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.

それは何ですか

$214,200.00 - $302,400.00

これは、勤務地、候補者のスキル、経験、教育レベルなど、多くの要素を考慮に入れています。その他の仕事関連の要因.

Kenvueは機会均等雇用者であることを誇りに思っています。人種、肌の色、宗教、性別、性的指向、性同一性、年齢、出身国、または保護された退役軍人の地位に関係なく、すべての資格のある応募者は、能力に基づいて雇用の検討を受け、障害に基づいて差別されることはありません。