Quality System Support Lead

Quality System Support Lead

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:

COMPLIANCE MANAGER

Location:

North America, United States, Puerto Rico, Las Piedras

勤務地:

フルオンサイト

あなたがすること

This position reports to the Compliance Manager and is an on-site role based in Las Piedras, Puerto Rico.

 

The Quality Systems Support Lead supports the coordination and continuous improvement of key Quality Systems, including Change Controls, Annual Product Reviews (APR), Document Control, Training, and Investigations. This role partners cross-functionally to ensure compliance with cGMP requirements, FDA regulations, internal procedures, and quality standards while driving the timely execution and effectiveness of Quality Systems processes. The position also serves as a backup to the Quality Systems leadership team and supports key site initiatives related to quality and compliance.

 

Key Responsibilities

• Support the administration, execution, and continuous improvement of Quality Systems processes, including Change Controls, Annual Product Reviews, Document Control, Training, and Investigations.
• Coordinate cross-functional activities to ensure timely completion of quality-related initiatives and commitments.
• Monitor, analyze, and report Quality Systems metrics, trends, and performance indicators.
• Identify recurring issues, quality risks, and process improvement opportunities and communicate recommendations to leadership.
• Develop, revise, and implement procedures, specifications, and policies to ensure compliance with regulatory and internal requirements.
• Support regulatory inspections and external audits as required.
• Represent Quality Systems in cross-functional meetings, projects, and governance forums as needed.
• Serve as backup to the Quality Systems Manager and support the coordination of departmental priorities and activities.

Quality Systems Management

• Support the full lifecycle management of Change Controls, including review, approval, implementation, closure, system administration, metrics monitoring, and user support.
• Coordinate and prepare Annual Product Reviews (APRs), ensuring timely completion, approval, trend analysis, and compliance with applicable procedures.
• Support Document Control activities, including periodic review, approval, maintenance, and effectiveness of controlled documents and SOPs within electronic systems.
• Participate in Training Program activities, including curriculum development, training effectiveness assessments, compliance monitoring, and training requirement evaluations.
• Support investigations related to non-conformances, process failures, and quality events, ensuring root causes are identified and effective corrective and preventive actions are implemented.

Analytics & Continuous Improvement

• Analyze quality system trends, recurring situations, and significant quality events to drive continuous improvement.
• Develop reports, dashboards, and presentations to support Quality Council reviews and leadership decision-making.
• Participate in Communities of Practice and cross-site initiatives to drive standardization, best practices, and compliance excellence.
• Support implementation of action plans resulting from audits, inspections, investigations, and quality reviews.

What We Are Looking For

Required Qualifications

• A minimum of a Bachelor’s degree in Science, Engineering, Pharmacy, or a related discipline.
• Five to ten years of experience within the pharmaceutical manufacturing industry.
• Strong knowledge of solid dosage manufacturing processes.
• Experience supporting Quality Systems, including Change Controls, Investigations, Document Control, Training, and/or Annual Product Reviews.
• Knowledge of 21 CFR Parts 210/211 and DEA regulations, as well as experience with FDA inspections and site readiness.
• Knowledge of cGMP, QSR, ISO requirements, applied statistics, and failure mode analysis techniques.
• Experience preparing technical reports, metrics, and presentations.
• Strong written and verbal communication skills in English and Spanish.
• Experience working with electronic Quality Systems platforms and document management systems.
• Ability to work independently, manage multiple priorities, and collaborate effectively across functions.
• Regulatory audit support experience.

Preferred Qualifications

• Green Belt certification.
• Project Management certification.
• Knowledge of KPS and Process Excellence methodologies.
• Experience serving as a system administrator or power user for electronic Quality Systems platforms.

#LI-AP3

それは何ですか

$90.950,00 - $128.400,00

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。