Sr. Manager Document Control and Training

Integra LifeSciences

83d

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. 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.

Requirements

• 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.
• Knowledge of 21 CFR Part 11 and Computer/Quality System Software validation.
• 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.

Nice To Haves

• Proficiency in training management and product lifecycle management (Agile) systems.
• Ability to communicate well with all levels of management.

Responsibilities

• Drive standardization & deploy world-class solutions to drive improved quality and compliance.
• Lead major improvements to existing processes and develop or champion new systems, concepts, and procedures to solve unique and complex problems.
• 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.
• 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.
• Serve as business process owner for quality system document and records control and training systems.
• Supervise the Quality System Training Program, including the implementation of a new learning management system.
• Manage the corporate record retention program.

Benefits

• Equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
• Commitment to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees