Compliance Specialist (CSV)

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.We are seeking a dedicated and detail-oriented Computerized Systems Validation (CSV) Quality and Compliance Specialist to join our Quality Assurance team. In this critical role, you will provide essential support for our enterprise systems, ensuring that all GxP and non-GxP computerized systems meet internal quality standards and global regulatory requirements. You will play a key part in maintaining compliance throughout the System Development Life Cycle (SDLC), supporting validation efforts, and contributing to IT project delivery with a strong focus on quality governance.Key ResponsibilitiesProvide general quality and compliance support for CSV Enterprise Systems, ensuring all GxP (e.g., GMP, GCP, GLP) and non-GxP computerized systems comply with internal quality standards and global regulatory requirements (e.g., FDA, EMA, ICH guidelines).Offer quality oversight for computerized systems across the entire SDLC, from design and development to decommissioning.Ensure ongoing compliance with applicable regulations, internal policies, procedures, and best practices.Support validation activities, including planning, execution, and reporting for computerized systems.Maintain and update validation documentation, Standard Operating Procedures (SOPs), and training materials to reflect current standards and requirements.Review and approve change controls, deviation reports, and associated documentation to mitigate risks and ensure system integrity.Analyze audit and inspection findings, collaborate on root cause investigations, and support remediation efforts to address non-compliances.Partner with IT teams on project delivery, emphasizing quality governance, risk assessments, and compliance integration from inception to go-live.Participate in cross-functional teams to promote a culture of quality and continuous improvement in computerized systems management.Qualifications And RequirementsBachelor's degree in Computer Science, Information Technology, Life Sciences, Engineering, or a related field; advanced degree or relevant certifications (e.g., ASQ, ISPE) preferred.3+ years of experience in Computerized Systems Validation (CSV), quality assurance, or compliance roles within a regulated industry (pharmaceuticals, biotechnology, or medical devices).Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and other global standards for electronic records and signatures.Proven experience with SDLC methodologies, validation protocols (IQ/OQ/PQ), risk-based approaches, and change management processes.Familiarity with tools and systems such as document management software (e.g., Veeva, MasterControl) and enterprise IT platforms.Excellent analytical, problem-solving, and communication skills, with the ability to collaborate effectively across teams.Attention to detail, organizational skills, and the ability to manage multiple priorities in a fast-paced environment.Preferred: Experience with audit/inspection readiness and remediation in a GxP setting.We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***