Job Description

Data Integrity Manager
Job Number: 21-11951
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Data Integrity Manager for our client in Summit, NJ
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • Global Quality Systems- Device and Combination Quality department within the Global Quality Systems organization and is responsible for providing support to the Lead for the Director of QMS for Devices across the end-to-end product lifecycle to ensure that regulatory and Client requirements are addressed thoroughly and effectively in a timely manner.
 
Responsibilities:
  • Work with Procedural Documentation Manager to on ongoing integration and optimization initiatives, ensuring new processes align with global internal and external regulatory requirements for the Device and Combination Product organizations.
  • This person will help design and implement a restructured role-based training curricula and develop tools for training needs identification specific to the Device organizations (Quality, MS&T, and Device Development teams).
  • Once the new structure is developed, the candidate will then develop tools to align with global requirements to reconcile/remediate training assignments to all personnel across Device Quality.
  • In addition, this person will create quality checklists for global Level 1 and Level 2 processes, and then review all local procedures using the created checklists, and compile a list of gaps noted.
 
 
Required Skills:
  • Experience in a Quality Role
  • Experience working with Medical Device/Combination products preferred, particularly EU MDR requirements and ISO13495.
  • Recent Data Integrity experience in a GxP environment
  • Ability to collaborate and lead cross-functionally to help drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites
  • Provide subject matter expertise in regulatory requirements, expectations, specifications/methods/compendia, manufacturing technology, and/or quality assurance is required.
  • Ability to build alignment with business partners including device development, MS&T, and cross functional quality organizations
  • Ability to demonstrate strategic thinking capability with strong project management focus as well as focus on execution of strategic decisions while balance conflicting priorities
  • Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
  • Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
  • Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes.
  • Must understand industry accepted device development and validation life cycle programs.
  • Excellent interpersonal skills, including written and verbal communication.
  • Strong sense of ethics, diplomacy and discretion.
  • Commitment to Quality.
  • Strong critical thinking to analyze complex situations and discern critical issues.
  • Able to work effectively with multicultural workforce.
  • Excellent team player attitude
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
June Binuya
junethel.binuya@eclaro.com
2128047476
June Binuya | LinkedIn
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
 

Application Instructions

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