At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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Job Description:

You will be responsible for:

• In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Lead and manage day-to-day document control activities for the QMS, including creation, review, approval, distribution, archival, and obsolescence of controlled documents (SOPs, work instructions, forms, policies).
• Design, implement, and maintain an effective training program tied to QMS documents, job roles, and regulatory requirements.
• Configure, administer, and optimize change control and training process to ensure data integrity, agile processes, and audit readiness.
• Serve as the primary owner for document change control processes  ensuring timely reviews and approvals.
• Develop and deliver training content (classroom, e-learning, on-the-job) and evaluate training effectiveness through assessments and metrics.
• Partner with cross-functional stakeholders (R&D, Manufacturing, Regulatory, Clinical, Supply Chain) to ensure documentation and training needs are met and aligned with product and process changes.
• Support internal and external audits and inspections by preparing documentation, responding to findings, and driving corrective actions.
• Monitor and report key performance indicators for document control and training (e.g., training completion rates, overdue trainings, document cycle times) and report them to quality data management review or management review. Mentor and coach staff involved in document control and training activities; foster a culture of quality and continuous improvement.
• Ensure records retention and confidentiality policies are followed and that document control activities meet company and regulatory requirements.
• Contribute to CAPA, risk management, and process improvement initiatives as they relate to documentation and training.
• Responsible for communicating business-related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Qualifications / Requirements:

EXPERIENCE AND EDUCATION

• University Bachelor’ degree in Engineering, Life Sciences, Quality Management, or a related field.

• 4 to 6 years’ experience in a highly regulated industry is required

• Demonstrated knowledge of QMS standards and regulations (ISO 13485, 21 CFR Part 820 / FDA QSR).

• Experience managing or administering an electronic document management system and training systems.

• Proven experience leading projects and/or small teams; strong organizational and prioritization skills.

• Excellent written and verbal communication skills; ability to write clear SOPs and training materials.

• Strong attention to detail and a systems-thinking approach.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Six Sigma Black/Green Belt, or equivalent certification is preferred.

• Excellent written and verbal communication skills; proven ability to interact with suppliers and cross-functional internal stakeholders.​
• Ability leads to change, drive reliability, and foster a culture of quality and safety.

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