Data Integrity & e-compliance Manager.

Job Description Summary

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz!


Provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Sandoz procedures and quality standards.
Develop and implement data integrity strategies, participate in regulatory inspections and audits, and ensure compliance with regulatory requirements.
Support cross-functional CSV activities, collaborate with IT and labs, and lead data integrity investigations and the DLPM project.
Manage internal inspections, provide training on data integrity and CSV, and perform periodic assessments and audits. Stay updated on industry regulations, and serve as a subject matter expert for data integrity and CSV-related queries. Manage projects, including Quality Plan initiatives, and processes that support quality objectives to assure their compliance with GxP regulations.

 

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Develop and implement data integrity strategies, policies, and procedures to ensure the accuracy, completeness, and reliability of data across systems and databases.
• Participate in regulatory inspections and audits related to data integrity and CSV, ensuring compliance with applicable regulations and guidelines.
• Ensure computer system compliance and projects are executed with adherence to regulatory requirements (in terms of Sandoz standards and policies)
• Support cross functional department for review/approval of CSV activities, including risk assessment, qualification, testing, and documentation of computer systems to meet regulatory guidelines such as FDA, GxP, and other applicable standards.
• Collaborate with cross-functional teams, including IT and analytical labs to ensure seamless integration of data integrity and CSV activities across the organization.
• Lead the investigation related to Data Integrity at site.
• Lead DLPM (Data Life Cycle Pathway Mapping) exercises.
• Responsible for management of internal inspections and shop floor Data Integrity walkthroughs.
• Provide training to employees on data integrity principles and CSV processes, promoting a culture of data quality and system compliance.
• Perform periodic data integrity assessments and audits to identify and address any potential issues or vulnerabilities, providing recommendations for improvements.
• Stay up-to-date with industry regulations and trends related to data integrity and CSV, proactively recommending and implementing enhancements to ensure continuous compliance.
• Serve as a subject matter expert and point of contact for data integrity and CSV-related queries or issues, providing guidance and support to stakeholders as needed.

What you’ll bring to the role:

Essential Requirements:

• Functional Breadth.

• Critical Thinking.

• Investigation mindset

• Collaborating across boundaries.

• Practical experience in analytical skills and instrumentation.

Skills:

• Agility.

• Analytical Development.

• Audit Management.

• Auditing.

• Change Control.

• Health Authorities.

• Influencing Skills.

• Knowledge Of CAPA.

• QA (Quality Assurance).

• Quality Management.

• Risk Management.

• Root Cause Analysis .

• Self Awareness.

• SOP (Standard Operating Procedure).

• Technological Expertise.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! 

The future is ours to shape!

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

 

Skills Desired

Agility, Analytical Development, Auditing, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Six Sigma, Sop (Standard Operating Procedure), Technological Expertise