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Quality

Sr. Analyst (m/f/d) Records Management

  • Job Title Sr. Analyst (m/f/d) Records Management
  • Function Quality
  • Sub Function Quality Systems
  • Category Senior Analyst, Quality Systems (P6)
  • Location Aachen, North Rhine Westphalia, Germany
  • Date Posted
  • Requisition Number 2406187684W
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Description

Johnson & Johnson is currently seeking a Sr. Analyst (m/f/d) Records Management to join our Abiomed Team, located in Aachen, Germany. 

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/.

The Sr. Analyst (m/f/d) Records Management will be responsible for the successful establishment and implementation of Records Management (RM) policies, procedures, and strategies for the way records are managed at Abiomed sites to assure compliance with J&J WWRIM Standards, regulatory and legal requirements.  The Abiomed Records Senior Analyst  Manager oversees the strategy, implementation, and deployment of RM processes and procedures, ensures effective communication, training deployed throughout the business, and serves as the Records Management Subject Matter Expert (SME) in support of legal discovery requests, internal and external audits. Additionally, the position will have responsibilities in sustaining, monitoring improvement trends and presenting opportunities to senior management.

Responsibilities:

  • Global responsibility for Abiomed RM policy and procedures that align with J&J WWRIM standards and applicable Quality Standards
  • Ensures availability of appropriate Records Management training for all associates to comply with established requirements
  • Complies with WWRIM program requirements including, but not limited to, completing an annual WWRIM program assessment
  • Works with business to create, implement, and maintain a Records Inventory List (RIL)
  • Conducts RM Compliance Assessments/Internal Controls with the business units/departments
  • Manages RM services such as vital records, inactive storage solutions and/or acquire such services provided by external vendors, as applicable
  • Manages the transition of proprietary information for acquisitions, divestitures, facility closings and mergers for all related records and data
  • Collaborates with IT project teams to drive information and records standards into the design, implementation and support of new technologies per established WWRIM and IAPP Standards, as applicable
  • Partners and supports J&J Legal and outside attorneys with e-discovery and collection of documents
  • Tracks and maintains site metrics related to WWRIM requirements
  • Responsible for communicating business related issues or opportunities to next management level
  • 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.

Qualifications

Requirements:  

  • B.S. in business, education, science, or technology required
  • Minimum 4-6 years of Records Management leadership and/or implementation experience in a highly FDA/ISO regulated environment
  • Knowledge of medical device regulated industry required
  • Process Excellence certification preferred
  • "Out of the box" thinker with good interpersonal, communication, and influencing skills required to engage a wide range of people at all levels across the business
  • Ability to analyze, identify and resolve complex issues required
  • Ability to organize, prioritize, balance risk and handle multiple projects concurrently
  • Project Management skills and related certification preferred
  • Expert knowledge of physical and electronic RM principles, practices, and methodologies; ability to apply principles and theory to recommend practical solutions for real-world business challenges
  • Knowledge of Project Management principles and delivery
  • Strong track record of developing, coordinating and leading initiatives that cross several functional areas and building strong working relationships
  • Spoken and written fluency in English is a must, German skills are desirable

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