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Senior/Principal Data Integrity Specialist

Rentschler Biopharma Inc.
Milford, MA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Job Summary

 

Rentschler Biopharma, headquartered in Laupheim, Germany, is a leading contract development and manufacturing organization (CDMO), focused exclusively on client projects. Rentschler Biopharma offers process development and manufacturing of bio pharmaceuticals as well as related consulting activities, including project management and regulatory support. Rentschler expanded its global footprint by opening a facility in the Boston metro area in Milford, MA. This site answers our US clients’ strong request to bring our expertise, innovation and state of the art, high-quality development, and manufacturing across the Atlantic to better serve the unique US market, a key market for Rentschler Biopharma. Milford’s proximity to our key US clients and Boston metro’s many biotech startups, large pharmaceutical companies, incubator sites, world-class universities and biotech-focused research institutions enable us to strengthen our important US partnerships and forge new ones, elevate our technological capabilities and tap into the region’s wide pool of expert talent.

 

We are recruiting for a proactive, strategic, and “hands-on” Senior or Principal Data Integrity Specialist to join a growing and dynamic site. Come join our QA team in this new role and lead the implementation of our Data Integrity plan. You will have the opportunity to lead a cross-functional team and interact with all levels of the company. You should have a practical mindset to create a detailed project schedule and drive data compliance actions. 

 

Responsibilities

  • Maintaining Data Integrity compliance across disciplines in alignment with applicable regulatory requirements, industry standards, and company policies by utilizing a risk-based approach
  • Driving Data Integrity remediation activities in adherence to Data Integrity Program and maintaining Data Integrity Program Plans. Participating in data integrity assessments, providing guidance and quality oversight
  • Participating in computerized system lifecycle activities and continuous improvement initiatives by providing guidance and quality oversight on aspects related to data integrity 
  • Supporting data integrity investigations, change controls, and audits. Providing quality oversight for data integrity-related issues across disciplines 
  • Monitoring the Deviation system for any potential breach related to data integrity and report metrics
  • Maintaining metrics and KPI's for the Data Integrity program 
  • Supporting Data Integrity training across disciplines
  • Supporting internal audits and regulatory inspections as a Data Integrity Subject Matter Expert (SME)
  • Identifying continuous improvements to maintain and evolve compliance and quality culture

 

Qualifications 

 

  • Bachelors’ and/or Masters’ degree in Life Sciences or IT related discipline and 5+ years of experience in the industry
  • Wide range of subject matter expertise and working knowledge of data integrity regulatory requirements and guidance (e.g., MHRA, FDA, PIC/S, ISPE), 21 CFR Part 11 / EudraLex Annex 11 and Computerized System compliance. Technical understanding of biopharmaceutical and computerized systems. Experience in all clinical phases through commercial drug product and in Quality Assurance or other equivalent experience a plus
  • Ability to educate all functional areas of the importance of data integrity
  • Experience with key elements of the Quality Management System and risk-based approaches (FMEA, PHA, etc.)
  • Auditing experience preferred
  • Project management experience and ability to influence cross functional teams to ensure project success
  • Demonstrated initiative with ability to undertake additional responsibilities and respond to situations as they arise
  • Ability to independently manage priorities in alignment with department and site drivers
  • Ability to work in a very dynamic environment with a clear sense of urgency, manage competing priorities and deliver on commitments

 

Working Conditions

 

  • Office environment
  • Labs and manufacturing suite environment

 

Physical Requirements

 

  • PPE as required

 

Direct Reports

 

N/A

Rentschler Biopharma Inc.

Address

Milford, MA
01757 USA

Industry

Technology

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