About the position
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. The role involves close collaboration with R&D, Regulatory, Analytical, Manufacturing Plant Quality, and Operations to support the on-time launch of new products and changes, influencing these functions in the development of a new product quality plan and change control documents. The position is also a major contributor to issue resolution utilizing quality engineering skills to ensure on-time commercialization, responsible for the review, approval, and release of first to market of approximately 20 - 40 new products/improvements per year.
Responsibilities
- Knowledge of policies, procedures and metrics
- Standard computer based software knowledge
- Keeps accurate documentation and submits detailed reports to appropriate executives
- Skills in data analysis to report and present effectiveness of business processes
- High attention to detail, organization and accuracy
- Math abilities and working knowledge of data analysis/statistical methods
- Contributes to policy, strategy implementation, and execution of relevant policies and procedures across manufacturing sites
- Leads and directs strategic programs focused on meeting regulatory company requirements
- Manages and develops other members of the team
- Mentors others in technical areas of expertise
- Demonstrates broad business orientation
- Shows personal commitment to the vision and creates energy and optimism
- Develops others through coaching, feedback, exposure and stretch assignments
- Promotes a culture of collaboration and teamwork across organizational boundaries
- Demonstrates strong leadership skills
- Keeps current on trends in the marketplace, with the competition, and in the organization
- Tests, confirms and/or improves processes to ensure they are in control and being followed
- Monitors project progress and sets deadlines and budgets
- Solves issues quickly and efficiently
- Ensures Stakeholder Satisfaction
- Delivers project tasks on time
- Works cross-functionally to identify and communicate regulatory requirements
- Works cross-functionally to influence others to align with new requirements
- Oversees implementation to ensure adherence to new requirements
- Set requirements for suppliers and monitor their compliance
- Oversee all product development procedures to identify deviations from quality standards
- Monitors spend and identifies additional project needs
- Evaluates Project Performance
- Ability to prioritize and handle multiple projects simultaneously
- Communicates and engages appropriately with vendors/suppliers
- Conducts sensitive conversations in a confidential manner with vendors/suppliers
- Maintains sensitivity of communication with internal and external entities (e.g. stakeholders, vendors, suppliers)
- Monitors progress by maintaining dialogue on work and results
- Makes good and timely decisions that keep the organization moving forward
- Provides clear direction, removes obstacles, and holds self and others accountable
Requirements
- University's degree from an accredited institution in a related field
- Professional typically with 8+ years technical experience and a demonstrated track record
- Generalist in at least 2 areas: Consumer products, medical device, food, dietary supplements or pharmaceutical
- Supervisory experience preferred
- Contributions balanced between strategy and functional execution elements; independent; people management
- Consulted internally as an expert in 1 area of functional expertise
Nice-to-haves
- Practical understanding, interpretation, and application of ISO13485, MDSAP
- Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates issues to internal and external stakeholders, including Senior Management
- Ability to work with all levels of management and to build relationships across disciplines
- Excellent influence, persuasion, communication, and presentation skills
