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Job #02983

About our client Our client is an established CRO that is a leading resource for contract semisolid and liquid development, manufacturing and packaging services. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Director of Quality San Antonio, Texas Salary Highly competitive package, commensurate with experience Responsibilities 1) Direct, plan, administer and provide leadership for the personnel-related activities in multiple disciplines (with various levels of duties) 2) Develop and authorize implementation of site policies and procedures (SOPs) to ensure compliance with government requirements as well as corporate policies 3) Participate as a member of the site Senior Management Team developing site strategies, policies and successfully implementing them 4) Work with other Quality directors to ensure alignment of policies and procedures between as well as within sites 5) Represent company (at the director’s level) with customers and regulatory agencies 6) Ensure that site is compliant with applicable quality and regulatory requirements 7) Manage FDA and customer audits as well as CAPA 8) Ensure that all testing (chemical, microbiological and physical) is conducted in a timely fashion and within approved framework (SOPs, customers’ requirements, etc.) 9) Ensure that each finished product’s disposition reflects the company's commitment to integrity and quality 10) Generate functional and technically sound validation plans/protocols (process and cleaning) ensuring reliable and consistent process when placed into the ongoing operation 11) Ensure the timely testing and prompt evaluation of data generated through testing (chemical and/or microbiological) 12) Evaluate data to determine the product’s efficacy through its assigned expiry date 13) Ensure that procedures (SOPS and operating instructions) are available 14) Administer the documentation program for reviewing and approval 15) Investigate customer/consumer complaints and in-house generated excursions (process, technical, etc.) 16) Establish probable cause, to minimize potential impact, and/or reveal opportunities for improvement in operations (production, laboratories, etc.) and manage associated CAPA 17) Develop the logistics for and control of an accurate fee schedule and timely billing for company customers (testing, managed stability program, validation, etc.) 18) Review and revise (if necessary) test’s availability as well as service fees to reflect most current cost and expense of services performed 19) Develop and manage budgets for the Quality Team, supporting business initiatives as well as strategies 20) Develop and maintain relationships with customers for current as well as future products 21) Exercise general supervision over employees in the quality organization 22) Carry out supervisory tasks as per the organization's policies and applicable laws 23) Interview, hire and train employees 24) Plan, assign and direct work 25) Appraise performance as well as reward and discipline employees 26) Address complaints and resolve problems Requirements 1) Bachelor’s degree in Science (Chemistry or Microbiology preferred) 2) Minimum 15 years of experience and hands-on working expertise in OTC and Rx pharmaceuticals as well as NDA filed products 3) Experience in semi-solids, gels, aerosols and creams 4) Prior experience in a Director/VP’s role 5) Experience in laboratory management and GMPs 6) In-depth knowledge of FDA regulations and establishment of plant-wide quality systems 7) Excellent QA/QC managerial skills 8) Superb communication skills 9) Ability to interact with customers and colleagues at all levels