Senior Compliance Specialist
hace 3 horas
Kenvue is a leading consumer goods company that is shaping the future of everyday care. We are currently recruiting for a Senior Compliance Specialist to join our team in Mexico City.
Job SummaryThe Senior Compliance Specialist will be responsible for ensuring the quality and compliance of our products across the SelfCare Franchise in Latin America. This includes evaluating and analyzing quality aspects of new product introductions, business development, and changes to existing products.
Key Responsibilities- Participate in local and regional quality/compliance projects and act as the quality voice for new product introductions and new business development in LATAM for the Consumer OTC segment.
- Provide risk-based analysis of quality aspects related to new product introductions and new business development.
- Understand current and emerging regulations and their impact on quality, keeping affiliates and external partners updated and compliant on new regulations.
- Partner with adjacent areas of the business to build a robust strategy to achieve committed goals.
- Act as a critical voice for opportunities identified in the evaluation of follow-up studies.
- Ensure all products meet and/or exceed company and local government standards, evaluating regulations to provide risk analysis guidance and make decisions about GxP activities accurately.
- Conduct and track quality investigations and process deviations, and follow up to ensure corrective action has been taken.
- Develop and qualify new/current service providers/suppliers to attend regulations and Kenvue requirements.
Required Qualifications:
- Bachelor's Degree in Pharmacy, Chemistry, Engineering, or a related science is required. Pharmacy is preferred.
- Proven experience of at least 6-8 years in a regulated industry. Pharmaceutical Industry is preferred.
- Knowledge in Drug Product Manufacturing and Controls.
- Knowledge on regulatory requirements across the LatAm region, such as ANVISA, COFEPRIS, INVIMA, and ANMAT.
- Working knowledge of CAPA, Change Control, and General Quality Systems process.
- Advanced knowledge of Microsoft Office (Excel, PowerPoint, Word).
- Advanced to Fluent English.
- Fluent in Spanish.
Desired Qualifications:
- Basic to Intermediate Portuguese.
- Advanced technical training and experience using Statistics, Lean, and Six Sigma Methodologies.
- Strong analytic skills – Ability to standardize varying data process/inputs.
- Intellectual agility, curiosity, and creativity.
- Good communication, organizational, and interpersonal skills.
Kenvue offers a competitive benefit package, including paid company holidays, paid vacation, volunteer time, summer Fridays, and more. We also provide learning and development opportunities, employee resource groups, and a collaborative work environment.
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