Manager, Quality Control

Kenvue Inc.; Fort Washington (Montgomery County); On-site; USD 124,000 - 175,000; Full time

Benefits offered by this job

Competitive benefits

Paid holidays

Learning & development

Kenvuer Impact Networks

Job summary

KenvueはFort WashingtonのサイトでQuality Controlのマネージャーを募集しています。分析ラボを率い、部材・工程材料・完成品の試験、検証、データ管理を統括します。規制要件と社内基準を満たすことで、製品の品質と供給の信頼性を維持します。

候補者は8–10年の製薬業界経験と3年以上のリーダー経験を有し、cGMP/データガバナンスに熟達していることが求められます。英語での実務能力と部門間の協働が重要です。

Qualifications

• 化学または関連自然科学の学士号が必須。
• 製薬業界等の高度に規制された環境での8–10年の経験。
• 3年以上の監督・マネジメント経験。
• QC分析ラボの運用をリード/監督した経験。
• 湿式化学・機器分析の深い知識。
• Drug cGMP要件、データインテグリティ、規制文書の実務知識。
• 分析方法移管・資格取得・検証・関連プロトコルの監督経験。
• LIMS、Empower、電子記録とERPの実務知識とMS Officeの使用経験。
• 検査・データ監視・CAPAの実施と監督。

Responsibilities

• 分析ラボ活動をリードし、部材・工程材料・仕上げ品・安定性・クリーニング検証を支援。
• cGMP、環境・安全法規、規制要件に沿った適合性を確保。
• 人材育成・ラボパフォーマンス改善・サイト優先事項を推進。
• 分析機器の適格性・校正・保守計画を監督。
• LIMS/Empower等の電子記録とデータガバナンスを管理。
• 方法移管・検証・関連報告の審査・技術監督を提供。
• USP/NF等の更新・規制要件の適用を監視。
• OOS/OOT調査・CAPAの実施・効果検証を推進。
• 監査対応の準備・内部/外部監査での専門性を発揮。
• 予算管理・継続的改善を推進（Lean/オペレーショナルエクセレンス）。

Skills

Leadership

Prioritization

Communication

Problem-solving

Collaboration

Education

Bachelor's degree in Chemistry or related natural science

Advanced degree (Chemistry, Pharmaceutical Science, Business, or related)

Tools

LIMS

Empower

SAP

Job description

Kenvueは現在、a:

Manager, Quality Control

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hereをクリックしてください。

Role reports to:

Site Quality Director

Location:

North America, United States, Pennsylvania, Fort Washington

勤務地:

フルオンサイト

あなたがすること

The Manager, Quality Control is responsible for leading the site analytical laboratory and ensuring compliant, reliable, and timely testing in support of Fort Washington operations. The role oversees analytical testing of components, in-process materials, finished products, cleaning validation samples, and marketed-product stability samples. This leader ensures laboratory activities comply with current Good Manufacturing Practices (cGMP), all applicable environmental/health/safety laws and regulations, company standards, and applicable regulatory requirements while developing people, improving laboratory performance, and supporting site priorities.

Key Responsibilities

• Lead all analytical laboratory activities supporting components, in-process materials, finished products, stability, equipment-cleaning validation, and other site testing needs. Ensure work is performed safely, accurately, on schedule, and in accordance with approved procedures, specifications, cGMP, and data integrity expectations.
• Exercise appropriate laboratory decision-making authority, including escalating significant compliance, product quality, and data integrity concerns; placing testing, equipment, or laboratory activities on hold when warranted; rejecting analytically invalid work; and recommending interruption of laboratory operations when continued activity may affect compliance or product quality.
• Plan and schedule laboratory work to optimize the use of people, equipment, materials, and external testing resources. Forecast staffing, capability, and equipment needs in advance of operational and regulatory demand.
• Oversee qualification and requalification of analytical equipment and the laboratory calibration and preventive maintenance programs. Ensure laboratory equipment and systems remain suitable for their intended use.
• Provide oversight for applicable laboratory computerized systems, including LIMS and Empower, and ensure compliant use of electronic records and automated processes. Oversee laboratory data governance, review of electronic data and audit trails, appropriate system access and role controls, segregation of system-administration and operational responsibilities, and periodic review of laboratory computerized systems.
• Review or approve analytical method transfer, qualification, validation, and related protocols and reports, as applicable. Provide technical oversight for wet chemistry and instrumental analysis activities.
• Monitor, assess, and implement applicable changes to USP/NF and other relevant pharmacopeial requirements, regulatory expectations affecting analytical laboratory controls, and global laboratory standards and procedures.
• Ensure adequate resources and timely, scientifically sound execution of laboratory investigations, including out-of-specification (OOS) and out-of-trend (OOT) investigations. Participate in or review root-cause analyses, nonconformances, change controls, risk assessments, and other quality records; oversee development and implementation of appropriate corrective and preventive actions (CAPAs), evaluate CAPA effectiveness, and ensure timely escalation of potentially reportable or product-impacting results and significant issues through effective closure.
• Establish, monitor, and interpret laboratory and site metrics to identify signals, improve right-first-time performance, strengthen reliability, reduce cycle time, and support annual product and quality system reviews.
• Maintain the analytical laboratory in a state of inspection readiness. Serve as a laboratory subject matter expert during internal audits, corporate audits, and regulatory health authority inspections, and contribute to inspection responses and follow-up commitments.
• Lead, coach, and develop laboratory employees. Set priorities, clarify accountability, maintain training and qualification, support performance and development discussions, and foster an inclusive culture of open communication, ownership, collaboration, and continuous learning.
• Partner with Quality Assurance, Manufacturing, Engineering, Validation, Regulatory Affairs, R&D, Supply Chain, EHS, vendors, and contract laboratories to resolve issues and support new product introductions, technology transfers, post-approval changes, validation activities, and site initiatives.
• Develop and manage laboratory operating and capital budgets. Identify, prioritize, and implement continuous improvement opportunities using Lean and operational excellence principles.
• Perform other related duties as required.

What we are looking for

Required Qualifications

• Bachelor's degree in Chemistry or another relevant natural science.
• Minimum of 8 to 10 years of experience in the pharmaceutical industry or another highly regulated industry.
• Minimum of 3 years of supervisory or people-management experience.
• Experience leading or providing substantial oversight of Quality Control analytical laboratory operations.
• Thorough understanding of wet chemistry and instrumental analysis.
• Demonstrated knowledge of Drug cGMP requirements, laboratory controls, data integrity, and regulated documentation practices.
• Experience with laboratory investigations, analytical methods, equipment qualification, calibration, preventive maintenance, and inspection readiness.
• Strong leadership, prioritization, resource-planning, influencing, facilitation, oral communication, and written communication skills.

Desired Qualifications

• Advanced degree in Chemistry, Pharmaceutical Science, Business, or a related discipline.
• Experience overseeing a laboratory equipment qualification, calibration, and preventive maintenance program.
• Experience with analytical method transfer, qualification, validation, and validation of analytical computerized systems.
• Experience interacting with or supporting inspections by regulatory health authorities.
• Working knowledge of LIMS, Empower, SAP or another ERP system, electronic records, and Microsoft Office applications.
• Knowledge of statistical concepts, data trending, capacity planning, Lean principles, and continuous improvement methods.
• Experience supporting new product introductions, technology transfers, stability programs, cleaning validation, or post-approval changes.

#LI-SR1

それは何ですか

このポジションの新入社員の年間基本給の範囲:

$124,100.00 - $175,200.00

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.

• 競争力のある福利厚生パッケージ*
• 有給の会社の休日、 有給休暇、ボランティアタイム&詳細!
• 学習&開発の機会
• Kenvuer Impact Networks
• このリストは場所/地域によって異なる場合があります

*注:Kenvueの合計報酬には、給与、ボーナス(該当する場合)、および福利厚生が含まれます。あなたのタレントアクセスパートナーは、採用および採用中に、関連する場所の報酬提供総額と特定の給与範囲について詳しく共有することができます。採用プロセス.

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。

障害を持つ個人の方は、宿泊施設のリクエスト方法について、私たちの障害者支援ページを確認してください。