GxP Compliance Senior Specialist
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Job Location:
Prague - Czech Republic
Monthly Salary:
Not Disclosed
Posted on:
3 days ago
Vacancies:
1 Vacancy
Job Summary
We help the world run better
At SAP we enable you to bring out your best. Our company culture is focused on collaboration and a shared passion to help the world run better. How We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences values flexibility and is aligned to our purpose-driven and future-focused work. We offer a highly collaborative caring team environment with a strong focus on learning and development recognition for your individual contributions and a variety of benefit options for you to choosefrom.
What youll do:
As a GxP Senior Specialist at SAP SGSC you will be responsible for creating and maintaining GxP compliance strategies for SAPs solutions catering to the Life Sciences market. Youll play a pivotal role in shaping GxP-ready processes and controls ensuring that SAP solutions deliver exceptional value to our customers keeping GxP in perspective. This position requires deep industry knowledge in the Life Science Industry and the ability to collaborate across various teams to bring a successful and compliant product to market
- Develop and maintain GxP compliance strategies for SAPs public cloud solutions.
- Design GxP-readyprocesses and controls.
- Provide expert guidance on regulatory requirements (e.g. FDA 21 CFR Part 11 EU GMP Annex 11) to internal teams and customers.
- Assist in internal and external audits as well as regulatory inspections related to GxP compliance.
- Stay current with evolving GxP regulations and industry best practices ensuring SAP remains at the forefront of compliance.
- Conduct risk assessments and gap analyses of current systems against GxP requirements.
- Collaborate with development teams to ensure GxP considerations are integrated into product design and development lifecycle.
What you bring:
- At least 5 years of GxP Experience
- 7 years of overall experience in Life Sciences Industry in Security or GxP related roles.
- Proven track record of successfully driving the compliances of products
- Strong communication skills to engage effectively with customers and internal stakeholders building trustful and lasting relationships
- Comprehensive understanding of GxP-regulated industries with a strong focus on Life Sciences
- Strong analytical skills with the ability to translate data into actionable insights
- Bachelors degree in Computer Science Engineering Business or related field
- Demonstrated ability to balance customer needs technical constraints and business objective
Bring out your best
SAP innovations help more than four hundred thousand customers worldwide work together more efficiently and use business insight more effectively. Originally known for leadership in enterprise resource planning (ERP) software SAP has evolved to become a market leader in end-to-end business application software and related services for database analytics intelligent technologies and experience management. As a cloud company with two hundred million users and more than one hundred thousand employees worldwide we are purpose-driven and future-focused with a highly collaborative team ethic and commitment to personal development. Whether connecting global industries people or platforms we help ensure every challenge gets the solution it deserves.At SAPyou can bring out your best.
We win with inclusion
SAPs culture of inclusion focus on health and well-being and flexible working models help ensure that everyone regardless of background feels included and can run at their best. At SAP we believe we are made stronger by the unique capabilities and qualities that each person brings to our company and we invest in our employees to inspire confidence and help everyone realize their full potential. We ultimately believe in unleashing all talent and creating a better and more equitable world.
SAP is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to the values of Equal Employment Opportunity and provide accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying for employment with SAP and are in need of accommodation or special assistance to navigate our website or to complete your application please send an e-mail with your request to Recruiting Operations Team:
For SAP employees: Only permanent roles are eligible for the SAP Employee Referral Program according to the eligibility rules set in the SAP Referral Policy. Specific conditions may apply for roles in Vocational Training.
EOE AA M/F/Vet/Disability:
Qualified applicants will receive consideration for employment without regard to their age race religion national origin ethnicity age gender (including pregnancy childbirth et al) sexual orientation gender identity or expression protected veteran status or disability.
Successful candidates might be required to undergo a background verification with an external vendor.
Requisition ID: 427619 Work Area: Information Technology Expected Travel: 0 - 10% Career Status: Professional Employment Type: Regular Full Time Additional Locations: #LI-Hybrid.
Required Experience:
Senior IC
Key Skills
- Compliance Management
- Risk Management
- Financial Services
- PCI
- Banking
- Cost Accounting Standards
- Quality Systems
- Research Experience
- NIST Standards
- Securities Law
- SOX
- ISO 27000
About Company
SAP started in 1972 as a team of five colleagues with a desire to do something new. Together, they changed enterprise software and reinvented how business was done. Today, as a market leader in enterprise application software, we remain true to our roots. That’s why we engineer soluti ... View more
