Global R&D Quality Director
- 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.
- 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.
- 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.
- Directly supervise and manage the Technical Writer position to assist in the development and implementation of the R&D policy/procedure documents program.
- 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
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