Integra LifeSciences Holdings-posted 3 months ago
Full-time • Manager
Princeton, NJ
1,001-5,000 employees
Miscellaneous Manufacturing

The Sr. Manager, Document Control and Training is responsible for leading the Corporate Document Control and Training team and is the Enterprise Compliance Master Plan (ECMP) Quality Management System (QMS) team leader with responsibility to design, implement and oversee quality and compliance improvement and remediation strategies for document and record control, change management, and training administration program. The position is also responsible for assessing, developing and maintaining the Corporate Document Control and Training Administration Programs in compliance with U.S. and International requirements as defined in FDA Regulations, ISO Standards, European Medical Device Directives, and other International Regulations. This role will be responsible for leading a cross-functional team of individuals and partnering with global quality leaders to develop processes that result in attaining the company's improvement objectives and growth strategies across Integra manufacturing facilities and a diverse portfolio of leading medical devices. This role is crucial for ensuring the development, manufacture, and distribution of medical devices in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical and Medical Device Agency (PMDA), and other applicable regulatory agencies.

  • Drive standardization & deploy world-class solutions to drive improved quality and compliance
  • Recognized as a leading expert and internal thought leader in Document and Records Controls with highest level knowledge and broad, comprehensive knowledge of other QMS disciplines
  • Leads major improvements to existing processes and develops or champions new systems, concepts, and procedures to solve unique and complex problems that have a broad impact on the business
  • Provide strategic leadership to Global Document Control and Training team, including matrix partners at manufacturing sites
  • Ensure all quality document control and training processes meet the industry standards outlined by FDA 21CFR 820 and ISO 13485
  • Effectively identify, prioritize and manage document change requests to ensure balance in rolling out significant and non-significant changes
  • Manage the change management team and processes for the review, approval and implementation of quality system changes
  • Assess and develop quality system training and document control processes
  • Serve as business process owner for quality system document and records control and training systems
  • Potential to interact with external vendors for systems user requirements development
  • Supervising the Quality System Training Program, including the implementation of a new learning management system
  • Manage the corporate record retention program (archiving for offsite, electronic signature)
  • A minimum of a Bachelor's Degree in a Science/Engineering Mathematics, Computer Sciences or other relevant discipline
  • A minimum of 12 years of overall experience in the medical device/pharmaceutical industry
  • 7+ years of management experience
  • Demonstrated proficiency of QSR/GMP (21 CFR Part 820) regulations and ISO (ISO 13485) standards is required
  • Knowledge of 21 CFR Part 11 and Computer/Quality System Software validation is required
  • Strong oral and written communication skills and effective interpersonal skills
  • Strong experience leading deployment of enterprise quality management solutions
  • Experience in FDA controlled environment
  • Strong collaboration skills and experience working in a matrix environment
  • Ability to interface with technical and non-technical personnel
  • Ability to multitask, prioritize and meet deadlines
  • Proficiency in Microsoft Office (SharePoint, PowerPoint, Word, Excel, Adobe Acrobat, etc.) is required
  • Proficiency in training management and product lifecycle management (Agile) systems preferred
  • Ability to communicate well with all levels of management
  • Equal opportunity employer
  • Commitment to providing reasonable accommodations for disabled veterans or individuals with disabilities
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