Senior Quality Manager, Document Control and Training

Integra LifeSciences•Princeton, NJ

1d•$125,350 - $172,500•Onsite

About The Position

The Sr. Quality Manager, Document Control and Training is the 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 programs. 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 10 years of overall experience in the medical device/pharmaceutical industry or equivalent education and years of experience
7+ years of management experience
Demonstrated proficiency of QMSR/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-regulated 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 preferred
Ability to communicate well with all levels of management

Responsibilities

Drive standardization & deploy world-class solutions to drive improved quality and compliance
Recognized as a leader in document and record control, change management, and training administration with high-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 QMS 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 QMS improvement 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
Provide strategic leadership to Global Document Control and Training team, including matrix partners at manufacturing sites
Ensure all quality document and change 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)