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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。
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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：
Director Support to Marketed Products – OTC位置：
Europe/Middle East/Africa, Sweden, Skane, Helsingborg工作地點：
混合你會做什麼
This hybrid role integrates project management with technical process‑science to support the introduction, lifecycle management, and continued compliance of Self‑Care / OTC products destined for the China market. The position coordinates cross functional global projects, regulatory and change control activities, and provides hands‑on technical operations support, including formulation and manufacturing process expertise for solids, liquids, and gum‑based products.
The role supports delivering technically robust, compliant, and cost‑effective solutions, maintaining global alignment, and supporting expansion of existing products into new markets.
Key Responsibilities
1. Project & Portfolio Support
- Support new product introduction (NPI) projects for Self‑Care/OTC products imported from Europe into China.
- Coordinate lifecycle management (LCM) projects, including formulation changes, raw‑material qualifications, process optimization, packaging updates, and regulatory‑driven revisions.
- Contribute to global change control (GCC) and China‑specific change management to ensure timely approvals and regulatory compliance.
- Support introduction of existing products into new markets, ensuring technical readiness and regulatory alignment.
- Support scenario planning, risk analysis, and decision optimization for project strategies.
- Support project budgeting includes technical, regulatory, and financial considerations.
2. Technical Operations & Process Science
- Support Technical Operations activities for the qualification of alternative APIs, raw materials, and primary packaging for existing products.
- Support validation strategies (process, cleaning, packaging, material changes) for new products, new markets, or changes to existing processes.
- Support validation, characterization, and stability study protocols and reports.
- Partner with Production and Quality to develop or update batch manufacturing records (BMRs), packaging records, and batch documentation.
- Liase with production teams for new processes, validation batches, and technology transfer activities.
- Follow validation batches on the shop floor; collect and assess samples per protocol.
- Support manufacturing process troubleshooting, deviation investigations, and identification of corrective and preventive actions (CAPA).
- Ensure all activities comply with cGMP, internal Quality Systems, and China‑specific regulatory requirements.
3. Regulatory, Quality & Compliance Support
- Translate Chinese regulatory insights and requirements into clear technical actions for global teams.
- Prepare technical documentation to support registration filings, including process descriptions, risk assessments, and validation packages.
- Provide Technical Operations support for post‑approval variations, site changes, material substitutions, and market expansions.
- Ensure structured risk‑management integration across technical and project activities.
4. Cross‑Functional & Cross‑Cultural Collaboration
- Serve as the technical and project interface between China stakeholders and global teams (EMEA & APAC).
- Collaborate with external manufacturing partners, raw‑material suppliers, and packaging vendors.
- Navigate cross‑cultural interactions effectively, demonstrating transparency, respect, and strong stakeholder management.
- Communicate clearly and consistently with all stakeholders, ensuring visibility of risks, progress, and alignment needs.
Qualifications & Experience
Required
- Bachelor’s degree or above in Pharmacy, Chemistry, Chemical Engineering, or related field.
- 5+ years of experience in pharmaceutical process development, product development, or drug product manufacturing.
- Strong experience in process validation, including cleaning validation.
- Project management experience with the ability to manage multiple priorities and cross‑functional workstreams.
- Solid understanding of quality systems, GMP, regulatory expectations, and technical risk management.
- Strong analytical, scenario‑planning, and structured problem‑solving skills.
- Excellent verbal and written English; Mandarin is an advantage.
Desired
- Broad experience with solid, liquid, and gum‑based dosage forms.
- Knowledge of formulation science, process equipment, packaging systems, and scale‑up considerations.
- Strong shop‑floor presence; hands‑on, flexible, and proactive working style.
- Ability to influence without authority; strong leadership and team‑collaboration skills.
- Ability to work independently while managing multiple projects concurrently.
- Strong statistical literacy (e.g., DoE, SPC, validation statistics).
- Excellent presentation and communication skills.
- Financial and business acumen enabling integration of technical and commercial perspectives.
Key Competencies
- Project Management & Cross‑Functional Collaboration Skills
- Process Validation & Technical Operations
- Manufacturing & Regulatory Knowledge
- Problem‑Solving, Creativity & Risk‑Based Thinking
- Cross‑Cultural Communication & Collaboration
- Business & Financial Acumen
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