Global Document Control & Training Lead
A collective energy and ambition. A place where you can make a real difference.
We’re a company that genuinely cares about our people, our products, our consumers and the environment.
Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.
United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.
The Document Control Lead & Training Lead is responsible for assessing, developing and maintaining the Corporate Document Control and Training Programs in compliance with U.S. and International requirements as defined in FDA Regulations, ISO Standards, European Medical Device Directives, and other International Regulations.
Mature professional capable of working independently and in a team setting. Continually evaluate opportunities for improvement to increase efficiency while ensuring compliance to applicable regulatory requirements and standards. Requires the ability to produce results in a fast-paced environment to meet deadlines and to effectively prioritize based on criticality.
Role Accountabilities and Responsibilities
- Collaborates with process owners and stakeholders to prioritize, release and implement corporate quality system changes and updates to Global Standard Operating Procedures (GSOPs).
- Proved strategic leadership for Global Document Control and Training programs, including Global partners.
- Manage and maintain global GxP controlled documents
- Support controlled document (policies, SOPs, work instructions, etc.) authors/owners in functional areas and assists in creating and/or revising documents.
- Provide quality perspective and expertise as the global point of contact for document management. Escalate issues as appropriate.
- Perform base business Document Control duties independently including: Process Document Change Control packages and review for correctness and completeness; monitor and update in-process documents.
- Develop and manage review process for global procedures.
- Assist in the preparation of global document control and training metrics and reports.
- Lead and coordinate other duties as assigned.
- Excellent communication skills and strong customer focus with ability to interact in a global, cross functional organization.
- Ability to prioritize and manage workload. Ability to meet challenging timelines, in spite of obstacles.
- Excellent writing, editing, and formatting skills.
- Demonstrate global GxP knowledge with a global understanding of phase appropriate application to regulations.
- Excellent problem-solving abilities to resolve routine and complex issues.
- Excellent customer-service orientation, high degree of professionalism, ability to work with limited direction and work successfully within a global environment.
- Demonstrate a positive, 'can do' and solution-oriented attitude.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Ability to learn and utilize computerized systems for daily performance of tasks.
- Excellent organizational skills, attention to detail and solution focused.
- Excellent project management skills to prioritize multiple tasks and goals and ensure timely and on-target accomplishment.
- Ability to build trust and respect within the organization.
Education and Experience
At least 3-5 years of equivalent experience in an FDA regulated environment
Bachelor’s degree in a science-related field
Prefer at least 2-4 year of experience in a Document Management & Training role
Working knowledge of medical device regulations, FDA Code of Federal Regulations (CFR), Title 21, Part 820, Quality System Regulation, ISO13485 & MDSAP
An organized, analytical thinker with exceptional attention to detail
An excellent communicator, both oral and written
Experience with Electronic Document and Training management systems
Working knowledge of Windows and Share Point
Able to manage multiple projects and meet project deadlines
Experience with training coordination or training programs
Experience with Quality Systems
Skills and Competencies
Strong organizational skills
Accustomed to and comfortable with managing/utilizing various software programs Ability to adapt to change
Ability to work under fast-paced conditions
Ability to communicate effectively (both verbal and written)
Ability to make decisions and use good judgment
Ability to prioritize various duties and multitask as required
Ability to collaborate and work successfully with others
Additional duties as assigned
Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.
For more information on our company, our brands and our culture visit us at http://www.churchdwight.com/
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DIVERSITY At Church & Dwight
Church & Dwight strives to create an environment where everyone feels free to bring their authentic self to work every day.
We win when we respect every employee for who they are – regardless of gender, age, race, ethnicity, religion, disability, veteran status, sexual orientation or any other differences. We believe that our employees’ contributions are richer because of their diversity. We aim to be a diverse, inclusive and equitable company and are determined to build a culture where people have the power to win together.
CULTURE At Church & Dwight
We care - about our people, our products, our consumers and our environment. To honor these priorities, we’ve built our culture around the tenants of courage, determination and team spirit. We’re united by our small company feel and inspired by opportunities to make our mark.Learn More
Equal Employment Opportunity for the Disabled At Church & Dwight
As an equal opportunity employer, Church & Dwight is committed to providing access and opportunities to individuals with disabilities. Applicants who require accommodation in the job application process may contact 877-809-8449 or email their resume and cover letter to email@example.com. Please note that these options are available only to those needing an accommodation because of a medical condition or disability. All email submissions should include “Accommodation needed” in the subject line as well as information related to the specific position you are interested in (requisition number, job title, location, etc.). Church & Dwight will not respond to inquiries made to firstname.lastname@example.org or 877-809-8449 that are not related to accessibility of the online application system by persons with medical conditions or disabilities. To review Church & Dwight’s Equal Opportunities Employer Policy, click link below.Learn More