This role encompasses both quality and manufacturing functions. This role requires strong experience in consumer goods manufacturing, preferably in FDA regulated spaces. The person must be obsessed with the consumer experience and be able to demonstrate how driving quality standards and processes are linked to this. The successful candidate will be comfortable with building strategy from ambiguity, have strong attention to detail, self-motivated to learn new categories quickly, strong vision for quality standards, strong interpersonal skills and ability to communicate clearly, identify patterns from large sets of data, and be motivated by a fast-paced dynamic environment.
- Support quality assurance and operation programs, ensuring adherence to cGMP, support product compliance, testing requirements, ensure compliance with final product testing, ongoing manufacturer quality programs, and leading troubleshooting activities with suppliers.
- Support cross-functional teams in assessing and working with chosen suppliers to ensure an optimized manufacturing process is in place, including all aspects of raw materials, packaging, authenticity, process controls, documentation, required equipment, and test parameters are in place to deliver against the consumer and brand needs.
- Identify and communicate roadblocks or risk areas for quality and timing, and provide solutions to help ensure products launch on time and on budget without compromising customer satisfaction.
- Experience creating, implementing and maintaining internal quality systems/document management systems, standards/SOPs for internal and external applications.
- Supporting audit processes and tools to ensure supplier compliance to internal and external standards and requirements and driving CAPA closure as needed.
- Provides direction, training and leadership to quality control personnel and related team members
- Develop tools to improve efficiencies such as Go/No Go Gauges
Skills and Required Experience
- Bachelor’s degree in Engineering or Quality Management from a 4 year college or university and at least 5 years of previous experience in Quality in the pharmaceutical/packaging industry with progressive responsibilities.
- 5+ years of related experience in a Quality Manager role with supervision responsibilities with multiple production shifts
- Experience in FDA/EPA regulated space
- Excellent user with Microsoft Office suite tools: Excel, PowerPoint, Word.
- Enhanced communication skills (both written & verbal); ability to interface with personnel at all levels throughout the business
- Demonstrated analytical ability
- Strong “hands-on” operational background with Quality / Supplier involvement
- Team oriented
- Statistical sampling & Inspection per ANSI AQL Ruler
- Sense of urgency
- Normally works with minimal direction
- Certification in Six Sigma Yellow/Green Belt and Lean manufacturing a plus
Grasping, Feeling, Talking, Hearing, Sitting
Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
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