Commercial Quality is the global Johnson & Johnson organization within each sector responsible for Quality support to the commercial operations space, including distribution, in full compliance with health authority regulations and the J&J Quality Standards. This position is part of the Commercial Quality Shared Services (CQSS) organization and leads the Temperature Control Support Center which provides technical expertise and services to the Deliver organization including global Transportation for both MedTech and Innovative Medicine.  Furthermore, this position ensures that there is a consistent and optimized temperature control program globally to support new product introductions and cost improvement projects.

This role develops and implements qualification guidelines for temperature control equipment and monitors as well as maintains a global temperature control Approved Supplier List (ASL).

• Leads Global Temperature Control Support Center with dotted line reports in the 4 regions.
• Ensures consistency and interpretation of temperature requirements globally. Incorporates changing global regulatory requirements into J&J processes and standards.
• Identifies, qualifies and deploys optimal solutions that address the storage and distribution temperature needs of the globe. Development of strategy to optimize the portfolio of current and future temperature solutions.
• Develops/implements qualification and validation guidelines and standards for temperature solutions.
• Develops and maintains strong collaborative relationships with Deliver including global Transportation, Segment Commercial Quality, Franchise Product Quality Owners, and R&D.
• Interacts with various regional stakeholders to provide consistency in approach towards compliance/standards.
• Proactively drives ongoing improvements to the business processes and systems in support of key business objectives including new product introductions and cost improvement projects.
• Ensures compliant regional execution and implementation of transportation lane mapping studies and maintains ambient temperature profiles and methodology thereof.
• Provides supplier management for global temperature control suppliers.
• Oversees the global temperature control certification program.

Education:

• A minimum of Bachelor’s degree is required. Focus degree in pharmacy, engineering, or a scientific field is preferred. Master’s degree in engineering, science, or business is preferred.

Experience and Skills Required:

• A minimum of ten (10) years of experience in a regulated industry.
• Previous experience in quality, regulatory and regulatory compliance competencies in the areas of: transportation, customer service, distribution and commercial operations.
• Decisive, organized, and able to lead people within a complex global environment.
• Previous experience working with global regulatory agencies, e.g., ANVISA, INVIMA, FDA, MHRA, TGA, notified bodies, etc, and a history of success and credibility resolving complex regulatory compliance issues.
• Excellent communication / presentation skills, able to encourage trust and quickly build credibility within the Quality & Compliance, Supply Chain, and Commercial organizations.
• “Hands-on” operational orientation with an attitude of learning.
• High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others.
• Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally.
• Builds consensus and impacts outcome without always having line authority and can develop trade off decisions across the organization.

Experience and Skills Preferred:

• Demonstrated ability to build and influence strong partnerships internally and externally with customer focus.
• Expertise in temperature control and monitoring.
• Strong project management skills.

Others:

• Proficient in written and spoken English is required.
• Ability to travel up to 30% travel, domestic and/or international, is required.
• Remote work could be considered from other Johnson & Johnson locations.