Quality Lead, Global Distributor Network - Vogue International

Quality Lead, Global Distributor Network - Vogue International

Location: Zug, Switzerland (preferred)

Vogue International, a Johnson & Johnson Company, is an innovative consumer products business that distributes cutting-edge hair care products to large retail chains around the world. These brands represent an innovative hair care business which is new to our Consumer Family of Companies and focused on the marketing, development and distribution of salon-influenced and nature-inspired hair care and other personal care products. With several strong brands among its portfolio, including OGX® and MAUI MOISTURE®, the Vogue business is the cornerstone of Johnson & Johnson Consumer’s hair care operations. Vogue International products are sold in more than 40 countries.

The newly created post of Quality Lead will work as an integral part of a highly collaborative, cross-functional, global team who will support the distributor markets in APAC, LATAM, and EMEA. You will be responsible for working with Regional BQ partners to complete quality requirements for distributors. You will be an integral member of a project teams to ensure compliance and quality requirements are met during global expansion of the distributor markets.

The Quality Lead will also support New Product Launches in these distributors. You will be responsible for complying with processes and controls ensuring that the performance and quality of new products conform to established standards, J&J Global and Regional policies and procedures, U.S. and Global Quality System Regulations (QSRs) including 21 CFR 210 & 211, 21 CFR 820 and 21 CFR Part 11 and current Good Manufacturing Practices. The products managed are a regulatory classification of Cosmetics.

Key Responsibilities include but are not limited to:

• Member of Vogue’s Global Growth Squad supporting the launch of products within Vogue’s Global distributor network.
• Guide Global growth squad members on quality requirements for Vogue distributors.
• Partner with Regional BQ to audit and qualify Vogue distributors.
• QA oversight responsibility for high-complexity, new product introduction projects across the Vogue distributor network.
• Provide communication to QA and cross-functional management on status of key initiatives and issues.
• Subject Matter Expert (SME) for quality assurance processes, procedures, audits (internal and external), and activities. Remain current on assigned quality system training and seek out training and knowledge in adjacent areas.
• Troubleshoot high-risk/high-complexity quality/compliance issues, using experience, ingenuity, and creativity to provide solutions to a wide range of root causes.
• Represent Quality Assurance function on multiple, simultaneous, high-impact/high-value projects as the “Voice of Quality”, including active team engagement, proactively ensuring that quality and compliance inputs are integrated into project objectives, and act as a QA “go-to” resource for Global Growth Squad business partners.
• Independently manage and prioritize highly complex and diverse workload, ensuring that deliverables are on-time, accurate, and meet their intended objective.
• Independent decision-making authority and accountability for product disposition and compliance decisions with significant potential impact to customer service.
• Review and approve compliance records, specifications, new product introduction development plans, procedures, and other documents with significant regulatory compliance impact.
• Brings forward innovative process improvements to drive compliance and/or efficiency.
• Hold business partners accountable for meeting project development plan requirements, and independently drive timely completion of validation activities at external sites.
• Independently interact with senior Quality leadership to negotiate and influence quality decisions.

Qualifications

• Bachelor’s degree is required. A focused degree in a technical field (Engineering, Sciences, or similar disciplines) is preferred.
• Solid work experience in GMP experience in either Pharmaceutical, Medical Device Manufacturing, OTC Drug, Cosmetic, and/or Food and Dietary Supplements production is required.
• Experience in New Product Development Quality and Quality Systems is preferred.
• Experience in R&D, Process Development, Technical Transfer, Analytical Chemistry, Clinical Research, Microbiology or Product Safety is preferred.

• Detailed working knowledge of cGMP requirements and current FDA enforcement issues is required.

• Excellent verbal, written and presentation skills are required. Proficiency utilizing the MS Office Suite (Project, Work, Excel, PowerPoint, Visio, Outlook, SharePoint) is required.

• Exceptional leadership and organizational skills.

• Knowledge of Quality system regulations (ISO/GMP/BSI/FDA).
• Ability to coordinate with multiple departments and handle multiple priorities successfully.
• Fluent in English required.

Primary Location
Switzerland-Zug-Zug- Organization
Cilag GmbH International (8525)
Job Function
Quality
Requisition ID
2005879805W