Sr. Manager Document Control and Training

Job description

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.

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

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

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 https://jobs.integralife.com/total-rewards/

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 (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)

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 (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) .

If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

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.

Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)

Required Skill Profession

Other General