Senior Quality Manager, Document Control and Training

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.

SUMMARY

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.

RESPONSIBILITIES

QMS Lead:

• 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

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 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)

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• 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

• 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 30% travel

Salary Pay Range:

$125,350.00 - $172,500.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

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:
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Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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