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