Product Quality Lead

Role Summary

Reporting to the US Business & Product Quality Head, the Product Quality Lead is a technical expert in regulatory requirements, standards, and best practices in one or more regulatory classification areas. This position is responsible for quality oversight of new product launches, and product changes, ensuring to maintain high quality and applicable compliance. This position will work closely with R&D, Regulatory, Analytical, Manufacturing Plant Quality and Operations to support successful launches and influence these functions in the development of a new product quality plan and change control documents. The position is also a key contributor to issue resolution utilizing quality engineering skills to ensure on-time commercialization. This position is responsible for the review, approval and release of first to market of approximately 20 – 40 new products/improvements per year.

Key Responsibilities

· Quality oversight of new product development projects from conception to commercialization, involving both internal and external manufacturing.

· Lead cross-functional teams to support the resolution of corporate-level quality issues related to new product launches.

· Escalate areas of non-compliance to management and manage field actions as appropriate.

· Develop new processes and procedures that are effective, efficient, agile, and compliant to all applicable regulations and requirements.

· Oversee implementation of new processes to ensure adherence to requirements.

· Test, confirm and/or improve processes to ensure they are in control and being followed.

· Champion “lessons learned” reviews, implement key outputs and identify potential trends for improvement initiatives.

· Keep current on trends in the marketplace, with the competition, and in the organization

· Promotes culture of collaboration and teamwork across organizational boundaries

· Develops others through coaching, feedback, exposure and stretch assignments

Skills and Competencies

· Demonstrated ability to influence cross functionally to deliver against goals and objectives

· Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues to all levels of the organization.

· Ability to work with all levels of management and to build relationships across disciplines.

· Team minded, detail-oriented, proactive self-starter.

· Ability to prioritize and to handle multiple projects simultaneously.

· Global business mindset, understanding of commercial processes, strong business acumen.

· Practical understanding, interpretation, and application of GMPs.

· Working knowledge of data analysis/statistical methods

· Experience with investigations, CAPA, and field actions.

· Excellent influence, persuasion, communication, and presentation skills

· Strategic and creative problem-solving skills

· Approaches work with energy and optimism.

· Experience leading complex global projects a plus.

· Standard computer-based software knowledge (Microsoft Office Suite)

Education and Experience

· Minimum Bachelor’s degree from an accredited institution in a related field

· Minimum 10 years technical experience and a demonstrated track record

· In depth knowledge in at least 2 areas: Consumer products, medical device, food, dietary supplements, or pharmaceuticals

· Supervisory experience preferred

· Black Belt a plus

· Manufacturing plant experience and/or R&D process/product experience a plus