Director of Global QA Laboratory Program

## Description Provide global leadership and management to ensure that proper policies/procedures are established to meet industry regulations and company business practices for both Quality Assurance and R&D. This includes all regulatory compliance requirements for change management and documentation control for OTC and cosmetics products globally. Responsible for developing, implementing, and maintaining the corporate QA and R&D policies and procedures programs to ensure the company's quality reputation and regulatory compliance. In addition, manage the development and implementation of all corporate QA and R&D policy/procedure training as well as the technical writing associated with any document changes or new policies and procedures. (50%): * Responsible for leading the development and maintenance of a comprehensive set of corporate QA policies/procedures globally across QA, Supply Chain, and R&D. * Works with QA/R&D Senior Management to ensure these global policies/procedures build on a community of best practices and meet all company and regulatory requirements. * Leads a periodic policy/procedure review process that assures the policy requirements are current and applicable to regulations and business practices. * Develops an effective document collaboration process that assures draft global documents are appropriately and adequately reviewed, edited, and approved. * Leads and develops a two to three⁃year global policy/procedure strategy plan and every fiscal year develops an annual global document development plan that is approved by the QA/R&D leadership teams. (30%): * Responsible for developing and maintaining a comprehensive global training program for QA and R&D corporate policies/procedures. * Assure personnel is adequately trained and that they understand the corporate policy/procedure requirements as well as ensure that they have the tools and knowledge necessary to perform their essential tasks. * For approved global policy/procedure documents, ensure training records are documented and retained, including quizzes that demonstrate training effectiveness. (15%): * Manage and maintain the corporate part of the Open Text documentation software program that allows for the routing, tracking, approval, change control, and retention of both corporate QA/R&D global policies/procedures. * Oversee the security, access, and upgrades to the Open Text software system. (5%): * Directly supervise and manage the Technical Writer position to assist in the development and implementation of the R&D policy/procedure documents program. ## Qualifications * Advanced level MS Office skills (particularly MS Word). Skills in a range of industry DTP Software. * Professional understanding of templates, macros and styles. * Must be detail⁃oriented and able to work with a high volume of documents in a fast⁃paced environment. * Must be highly organized and process⁃oriented. * Must have excellent oral, written communication and listening skills as well as the ability to interact and influence with all levels of the organization. * Must be able to handle multiple requests while detailing document activity and have strong attention to detail. * Must be able to work both independently and within a team environment. * Must be able to focus on a task and follow a precise process to the conclusion. * Key knowledge should cover experience in documentation review, control, retention and maintenance. * 10 years with good experience in Quality Systems Management and implementation including hands on experience developing and writing technical documents, preferably in a regulated industry. * Minimum Education level: BS/MS