Manager, R&D Quality GMP

Company: Est--e Lauder Companies
Location: Iowa City
Posted on: March 19, 2023

Job Description:

Implement, maintain and continuously improve the R&D GMP Quality Management System including creation/revision/review of SOPs, administration of change management, timely completion of deviations and investigations, implementation of corrective and preventive measures, compilation of quality metrics etc. -Oversee document control/archiving processes. -Maintains awareness of current GMP trends and regulatory authority expectations. Responsible for informing management of quality issues in a timely manner. Exhibit professionalism and foster teamwork to create an environment of support that leads to productivity of R&D personnel and ensures GMP compliance. -50%: -Provide expertise and leadership on the activities and quality systems necessary to ensure that R&D is operating in full compliance with sound scientific practice, current Good Manufacturing Practices, as applicable, and standard operating procedures. Provide guidance and support to R&D colleagues with respect to change management, deviation reporting and other compliance activities. -Review and approve/reject data and documentation for GMP activities including, but not limited to, SOPs, batch documentation, IQ/OQ/PQ documents, protocols and reports, specifications, test reports etc. -Must have strong problem solving and decision making skills. -40%: Represent R&D QA on project teams and quality initiatives. -Provide input into development strategies to support innovation, achieve business objectives and maintain GMP compliance. -Reviews and approves dossiers to launch new products and line extensions. - - -10%: Perform internal and external quality audits and facilitate corrective actions. Represent R&D QA in internal audits and/or regulatory inspections. -Ensures responses to audit observations/inspection findings (internal and external) are completed in a satisfactory and timely manner. -QUALIFICATIONS

• BS or BA in Chemistry or related degree
• 5 years QA experienceMust have knowledge of cosmetic and OTC drug product regulations. Requires excellent communication skills to direct R&D personnel and discuss quality related issues with management. -The candidate must be able to work independently. -Ability to work on multiple projects and flexibility to adapt to changing priorities is a must. Must possess strong organizational and planning skills. -Expertise from R&D, manufacturing or process development experience is required. -Experience in a GMP regulated environment preferred. -The anticipated base salary range for this position is $81,000 to $133,000. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position is eligible for participation in a highly competitive bonus program with possibility for overachievement based on performance and company results. In addition, The Est--e Lauder Companies offers a variety of benefits to eligible employees, including health insurance coverage, wellness and family support programs, life and disability insurance, retirement savings plans, paid leave programs, education-related programs, paid holidays and vacation time, and many others. Many of these benefits are subsidized or fully paid for by the company.We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. It is Company's policy not to discriminate against any employee or applicant for employment on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. The Company will endeavor to provide a reasonable accommodation consistent with the law to otherwise qualified employees and prospective employees with a disability and to employees and prospective employees with needs related to their religious observance or practices. Should you wish to apply for this position or any other position with the Company and you believe you require assistance to complete an application or participate in an interview, please contact USApplicantAccommodations@Estee.com.

Keywords: Est--e Lauder Companies, Iowa City , Manager, R&D Quality GMP, Executive , Iowa City, Iowa