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 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
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Enterprise Compliance Master Plan (ECMP):
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
Evaluate new regulations, guidelines and industry standards and their impact on ECMP QMS Workstream processes; plan and effectively implement plans across the business to maintain compliance
Establish an Enterprise-wide Document and Records Control program, including governance and oversight, to ensure compliance and consistency in areas of document and records control, change management and training administration
Ensure compliance with all process and digital improvements with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, EU MDR and PMDL
Interact and coordinate activities with other departments, external vendors, and customers. Influences and collaborates across stakeholder groups in the areas of process / system improvements, identify and implement opportunities
Drive quality culture improvements and foster collaboration to ensure functional teams work harmoniously and secure synergy and strengths across the global teams
Provides strategic direction and communication of the CMP QMS workstream goals, directives, and policies to employees, creating a clear vision and positive, team-oriented environment resulting in the achievement of the company’s goals and increased profitability
Demonstrates technical leadership as an inter-departmental resource coaching and teaching other Integra Leaders across all functions and geographies
Perform other related duties as expected
Document Control and Training Administration:
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)
Qualifications
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
This position could require up to 50% travel
Integra LifeSciences is an equal opportunity employer, and is committed to providing 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.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.
Integra - Employer Branding from Integra LifeSciences on Vimeo