Director of Quality
Director of Quality
Chief Operations Officer
Revision Skincare Headquarters (Irving, TX)
Revision Skincare, located in Irving, TX, provides dermatologists, plastic surgeons and medical spas with clinically-proven, high-performing skincare products. Using only premium quality ingredients, the Revision Skincare collection was formulated to provide targeted solutions for enhancing skin’s appearance and reducing signs of aging.
This position is ultimately responsible for maintaining the overall company quality standards, as directed by Revision executive management, which meet and exceed client and Federal / State / Local government expectations. It is also responsible for leading a team to continuously assess, manage and improve the Quality System utilized for Cosmetic and OTC products.
Primary responsibilities include (but are not limited to):
- Establishing and maintaining the structure for the Quality Management System including Procedures, SOPs, Work Instructions, etc.
- Manages company complaint process through the gathering, review and trending of all customer complaints. Identifies areas of concern and initiates actions for improvement.
- Manages Change Control Process including all Labels, Marketing Materials and Company Standard Operating Procedures (SOPs).
- Responsible for quality related project management of formulation changes from Ideation stage through Commercialization stage.
- Ensures compliance to all applicable Federal, State, and Local governmental regulations.
- Responsible for Company training and documentation of training for cGMPs, SOP Implementation and various other areas.
Essential Duties and Functions
- Proactively identifies and notifies upper management of quality issues and works towards issue resolution.
- Responsible for identifying serious adverse events and communicating with upper management the need for reporting such complaints as applicable.
- Conducts assessments and/or audits of all potential and current suppliers to determine capability and adherence to Company standards.
- Responsible for final review and or approval/rejection of all incoming components, marketing materials and finished product goods by ensuring predetermined specifications are met.
- Minimum of 5+ years in Quality Management experience with emphasis on standards development and implementation.
- Knowledge of/certification in quality methodology (Lean, Six Sigma, and/or other standards) and audit processes.
- Working directly with pharmaceutical, OTC drug and/or personal care products is highly desired, but not required.
- Experience with packaging of Consumer Packaged Goods preferred.
- Bachelor’s Degree (4 year degree) is required, Engineering Degree preferred.
- Lean, Six-Sigma Green or Black Belt preferred.
Other skills and abilities
- A thorough understanding of cGMP and FDA regulatory requirements (21 CFR 200, 300 & 700)
- Excellent analytical skills. Ability to analyze large quantities of data to extract relevant, meaningful insights and recommend potential actions
- Detail oriented with excellent problem solving abilities and root cause analysis experience
- Excellent verbal and written communication skills
- Must have experience with project/program management techniques and methods
- Must have excellent communication skills with a track record for coordinating initiatives across cross functional teams
- Ability to identify process improvement opportunities to continually improve performance, optimize quality, and increase agility
To apply, please e-mail a cover letter and resume to email@example.com
Revision Skincare is an Equal Opportunity Employer.
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