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