Integra LifeSciences · 3 months ago
Sr. Manager Document Control and Training
US-NJ-Princeton-100-Headquarters
Full-time
Onsite
Senior Level, Lead/Staff
$125K/yr - $172K/yr
12+ years expIntegra LifeSciences is a company dedicated to innovating healthcare solutions. The Sr. Manager, Document Control and Training will lead the Corporate Document Control and Training team, ensuring compliance with quality management systems and regulatory standards in the medical device industry.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
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 solves 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. Assess impact to business, sites and systems with stakeholders and develop risk-based strategies to ensure continued compliance
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. Identify and implement efficiencies for continual process improvement and ongoing compliance
Serve as business process owner for quality system document and records control and training systems; including identifying user requirements and working with IS to identify and deploy system efficiencies in conjunction with process improvements
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)
Qualification
Required
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
Ability to communicate well with all levels of management
This position could require up to 50% travel
Preferred
Proficiency in training management and product lifecycle management (Agile) systems
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
1001-5000 employees
H1B Sponsorship
Integra LifeSciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO
Leadership Team
Mojdeh Poul
Chief Executive Officer
Lea Knight
EVP and Chief Financial Officer
Recent News
Integra LifeSciences Holdings Corporation
2025-12-02
Company data provided by crunchbase