Data Integrity Program Manager - Quality Control

Location: Milford, MA, United States

Advancing medicine to save lives. Together.

Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.

Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.

As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.

The QC Data Integrity Program Manager identifies, implements, manages, and maintains strong Data Integrity Compliance activities within the Quality Control Department. The QC Data Integrity Program Manager, will be responsible for ensuring compliance and alignment to all relevant regulatory and internal requirements related to data integrity as well as developing training material and leading training efforts with Quality Control Staff.

Join our QC team with a quality mindset first to help make and release medicines for better lives. Our team is built on trust, respect, and integrity. The quality mindset is about operating with reliability, efficiency, and honest feedback.

Duties and 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 principals 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, work instructions

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 use of electronic data management and laboratory information management

Experience in quality system management (e.g., deviations, change controls, SOPs) is preferred

Thorough knowledge of regulatory issues and the impacts on discipline

Expert knowledge on 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 discipline, known as a SME in that discipline, and good knowledge of principles and concepts of other relevant disciplines

Excellent organization and planning skills

Strong attention to detail and ability to adhere to standards procedures

Strong project management skills and ability to lead effective change management are desired

Strong understanding of Computerized System validation principals

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 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