Deseret Laboratories, Inc.
Director of Quality Manager/Director
Deseret Laboratories, Inc., Saint George, Utah, United States, 84770
The Quality Operation Manager provides strategic quality leadership to the manufacturing/packaging teams and directs, evaluates and controls the activities of the QA function to assure its work is accurate, timely, efficient and compliant with company policies, industry standards and government regulations.
In addition, is responsible for batch release activities at the site and continuously improving the site quality investigation system ensuring robust investigations are conducted and CAPA are in place to improve quality and compliance at the site
Responsibilities
Ensure that product released is manufactured and/or packaged in compliance with regulatory agencies' requirements and company standards.
Provide quality leadership directly and indirectly through the Quality Operations to the Production, Technical, Engineering, Supply Chain, Quality Control and cGMP units to ensure their activities are in compliance with regulatory agencies' requirements, company standards, and site procedures (SOP's).
Establish a series of stretching, measurable improvement processes and metrics across the department which will be tracked to add value to both internal and external customers.
Lead complex and critical deviation including PIRC management process.
Interact with Regulators and internal auditors.
Provide responsibility for other quality, product, and/or compliance activities as assigned.
Quality Validation oversight (approval of validation protocols, validation master plan).
Responsible for Quality Complaint management program at the site.
Maintain departmental budgets and HR company policy.
Qualifications
Masters Degree or 8 years Quality Director/Manager experience in a Nutraceutical/Pharmaceutical environment a must.
Knowledge of cGMP's/FDA and other regulatory requirements such as ICH Guidelines 8,9,10,11.
Requires project management and leadership skills
Excellent verbal and written communication skills
Conflict resolution and interaction management skills
Excellent internal audit experience
Validation oversight (approval of validation protocols, validations master plan)
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In addition, is responsible for batch release activities at the site and continuously improving the site quality investigation system ensuring robust investigations are conducted and CAPA are in place to improve quality and compliance at the site
Responsibilities
Ensure that product released is manufactured and/or packaged in compliance with regulatory agencies' requirements and company standards.
Provide quality leadership directly and indirectly through the Quality Operations to the Production, Technical, Engineering, Supply Chain, Quality Control and cGMP units to ensure their activities are in compliance with regulatory agencies' requirements, company standards, and site procedures (SOP's).
Establish a series of stretching, measurable improvement processes and metrics across the department which will be tracked to add value to both internal and external customers.
Lead complex and critical deviation including PIRC management process.
Interact with Regulators and internal auditors.
Provide responsibility for other quality, product, and/or compliance activities as assigned.
Quality Validation oversight (approval of validation protocols, validation master plan).
Responsible for Quality Complaint management program at the site.
Maintain departmental budgets and HR company policy.
Qualifications
Masters Degree or 8 years Quality Director/Manager experience in a Nutraceutical/Pharmaceutical environment a must.
Knowledge of cGMP's/FDA and other regulatory requirements such as ICH Guidelines 8,9,10,11.
Requires project management and leadership skills
Excellent verbal and written communication skills
Conflict resolution and interaction management skills
Excellent internal audit experience
Validation oversight (approval of validation protocols, validations master plan)
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