Quality Systems Director

Quality Systems Director

 

Leiner Health Product

America’s largest store brand manufacturer of vitamins, minerals, supplements (VMS) and diet aids. Is searching for an exceptional Quality Systems Director. 

For the Opportunity of Your Life.... Come Join Our Team !

Leiner Employees EnjoyOn-Site Fitness CenterProduct Purchase Program (discount rates)

(Employee Store with over 90+ vitamin/health products items)On-Site Car Wash every WednesdayBusiness Casual EnvironmentAdvantage Club (discount cards to recreation and theme parks)

 

We offer the following benefits: Medical, Dental, Vision, Life, 401K, Employee Assistance Program, Educational Assistance, and Paid Holidays.

 

 As the Quality Systems Director you will be responsible for Direct, plan, administer, and pro responsibilities. Provide leadership for the activities of personnel in multiple disciplines with various levels of Develop and authorize the implementation of site policies and procedures (SOPs) to assure compliance with government requirements, and corporate policies. Participate as a member of the Senior QA Management Team developing site strategies, policies, and successfully implementing the same. Work with other Quality Directors to assure alignment of policies and procedures between and within sites. Must be able to represent

company at the Director level with customers and regulatory agencies.

Site Compliance: ensure site is compliant with applicable quality and regulatory requirements. Manage, and CAPA. Review organization for Technical and Compliance GAPS and provide technical resolution through a mentoring and team based approach.

Testing and Product Disposition: assure that all testing (chemical, microbiological, and physical) is 5. Procedures: assure that procedures (SOPS and operating instructions) are available, and administer the documentation program for review and approval.

Manage the Annual Product Review System and resolution of resulting technical issues.

Develop and provide technical training modules.

Review and approve customer/consumer complaints and in-house generated excursions (process, technical, etc.). Establish probable cause, to minimize potential impact, and/or reveal opportunities for improvement in operations (production, laboratories, etc.) and manage associated CAPA.  Develop and manage budgets for the Quality Team supporting business initiatives and strategies.  Customer Interface: Develop and maintain relationships with Customers for current and future products.

Exercises general supervision over employees in the Quality Systems Organization. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

 

Minimum Qualifications:Wide-ranging QA/QC managerial skills, a minimum of 10-15 years experience and hands-on work. This experience should encompass OTC, dietary supplements, and Rx Pharmaceuticals. Thorough knowledge of FDA regulations and involvement in establishing multi-plant quality systems also required. Communication skills and the ability to interact with customers and colleagues at all levels is required.Thorough knowledge of FDA regulations and involvement in establishing multi-plant quality systems also required.