Area Quality Lead

area quality lead

city: salt lake city

home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

in research and development, we're full of highly skilled talents that include scientists, engineers, medical, clinical and regulatory professionals - all working to create a cleaner, healthier world. With nine centres of excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.

We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality. The size of our organisation means you'll have the opportunity to learn and work in different functions within r&d, giving you exposure to different disciplines, teams and environments.

You will also have access to our research and development academy, designed to develop our team and allow you to grow in our great organisation.

the primary responsibilities of the area quality leader are to provide overall day-to-day management of quality system activities within their respective area. This includes oversight, planning and implementing quality improvement activities, assuring proper quality systems are embedded, establishing objectives for quality within site production operations. The position will routinely provide feedback to the quality team and production/operational teams on performance against quality requirements and support in the remediation of operational quality challenges, including implementation of proactive and reactive corrective actions/preventative actions.

• owns all area specific deviations and non-conformances from the quality perspective partnering with the manufacturing team and all other necessary support roles.
• interface with engineering support, technical, cl team, suppliers and r&d.
• support groups in delivering in‑house & regulatory standards of compliance to best business advantage.
• training and competency assessment of operational staff.
• to advise on, and assist with, practical operation changes and improvements.
• identifies and supports actions to resolve quality problems, both internal issue and from outside suppliers.
• identifies with psl where support is required from support teams.
• makes recommendations and acts to improve process, procedures and systems.
• assesses change controls, protocols and ncrs, recommends release or otherwise of product involved.
• co‑ordinate area document control and assists with training regarding quality system.
• chairs quality sections of group meetings.
• resolving on‑line issues regarding quality to the point of stopping production operation and.
• ensuring quality requirements and production requirements are considered, without detriment to either.
• product release or reject recommendation in the event of significant quality issues.

• ability to lead the development and implementation of quality processes to assure regulatory compliance, leading cross‑functional technical personnel, and coordinating the execution of multiple complex projects in a fast‑paced environment.
• must have a strong working knowledge of applicable parts of title 21 of the cfr, ich & competency of specific cgmps, and thorough understanding to manufacturing operational processes in the nutraceutical, pharmaceutical or medical device industry.
• experience using electronic quality management tools such as mastercontrol or trackwise is a plus.
• must have experience with quality tools such as: spc, advanced quality planning, control plans, fmea, root‑cause analysis, six sigma, cross‑functional problem‑solving teams, etc.
• experience…