Data Integrity Program Manager - Quality Control

Rentschler Biopharma; United States; On-site; USD 120,000 - 150,000; Full time

Job summary

Rentschler Biopharma is seeking a QC Data Integrity Program Manager to lead Data Integrity compliance activities within Quality Control and to represent the company during client and regulatory inspections. The role requires extensive expertise in regulatory data integrity requirements and validation of QC computerized systems.

You will develop training materials, manage remediation efforts for data gaps, and collaborate cross-functionally to ensure data integrity across Empower, Softmax, ViPER

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 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

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

Skills

Data integrity

Quality oversight

Computerized systems

Regulatory compliance

GxP knowledge

21 CFR Part 11

EU Annex 11

Project management

Audit support

Attention to detail

Tools

Empower

Softmax

ViPER Analytx

Job description

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 hasapproximately1,400 employees and is headquartered in Laupheim, Germany,with asite 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

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 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

Base Pay Range

$120,000 - $150,000

Disclosure Statement

Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include 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 just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees’ personal and professional wellness. The salary pay range is subject to change and may be modified at any time.