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Jobs · Quality Assurance · Massachusetts

Data Integrity Program Manager - Quality Control

Rentschler Biopharma · Milford, MA · 2 wk ago
Quality Assurance$120k–$150k/yrFull-time

About the role

As the QC Data Integrity Program Manager, you will identify, implement, manage, and maintain strong Data Integrity Compliance activities within the Quality Control Department. You will ensure compliance and alignment with all relevant regulatory and internal requirements related to data integrity, as well as develop training material and lead training efforts with Quality Control Staff. Join our QC team with a quality mindset to help make and release medicines for better lives. Our team is built on trust, respect, and integrity, operating with reliability, efficiency, and honest feedback.

Responsibilities

  • Implement and maintain Data Integrity compliance activities for all Quality Control systems in alignment with relevant regulatory regulations and guidelines.
  • Represent Rentschler as the QC subject matter expert during client and regulatory inspections related to data integrity.
  • Manage remediation efforts to identify data integrity gaps and risks and implement appropriate technical and procedural controls as required.
  • Provide oversight of data integrity compliance for software and instrument validation lifecycle activities associated with QC computerized systems to ensure conformance to GxPs, guidance documents, applicable industry standards, and Rentschler business practices.
  • Develop training material and lead training efforts with SMEs as it relates to Data Integrity principles and best practices.
  • Effectively manage and execute strategic business opportunities to improve business processes.
  • Provide day-to-day oversight for the governance, management, and coordination of activities in QC related to Data Integrity.
  • Work cross-functionally with other departments to provide support, guidance, and feedback on applying appropriate Data Integrity controls and best practices.
  • Author quality system documentation such as change control, deviations, CAPAs, SOPs, and work instructions.

Qualifications

  • 8+ years of relevant/relatable experience in data integrity, quality oversight of computerized system management/validation, QA compliance/regulatory, and/or similar areas of focus.
  • Must be familiar with the use of electronic data management and laboratory information management systems.
  • Experience in quality system management (e.g., deviations, change controls, SOPs) is preferred.
  • Thorough knowledge of regulatory issues and their impacts on the discipline.
  • Expert knowledge of industry data integrity principles and applicable regulations such as 21 CFR Part 11, EU Annex 11, MHRA GxP Data Integrity Requirements.
  • Advanced and deep knowledge of principles, concepts, and practices in the discipline, recognized as a subject matter expert (SME), with good knowledge of principles and concepts of other relevant disciplines.
  • Excellent organization and planning skills.
  • Strong attention to detail and ability to adhere to standard procedures.
  • Strong project management skills and ability to lead effective change management are desired.
  • Strong understanding of Computerized System validation principles.
  • Ability to drive functional, technical, and operational excellence.
  • Working understanding of applicable QC computerized systems and how they interact, such as Empower, Softmax, ViPER Analytx, and other similar software.
  • Good understanding of the complexity, interactions, and dynamics within an international company.
  • Experience supporting client or regulatory audits as it applies to Data Integrity.

Working Conditions

  • Normal office working conditions: computer, phone, files, fax, copier.
  • Working in the laboratory environment may be required when setting up LIMS master data.
  • Personal Protective Equipment (PPE) must be worn as required.
  • Minimum travel required.

Physical Requirements

  • PPE as required.
  • Manual and visual dexterity required to perform laboratory and computer tasks for prolonged periods.

Pay

Base Pay Range: $120,000 - $150,000. The actual compensation is determined based on several factors, including seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The annual base salary is one component of our Total Rewards package, which also includes an annual discretionary bonus program, medical insurance, a generous 401K program, and other benefits to support personal and professional wellness.

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