Senior Software Quality & Compliance Specialist
位置摘要：NMDP 正在寻找一位高级质量和合规专家加入我们的质量与监管事务团队！在这个角色中，高级质量与合规专业人员将为计算机化系统和数字解决方案提供独立的质量和监管监督。你将密切合作与 IT 和质量团队来评估 SDLC 实践，建立常规软件审计，评估风险，并积极识别符合性漏洞之前成为检查结果。这一职位是适合经验丰富的软件质量专业人员，拥有监管的 SDLC,内部审计，质量管理系统，质量风险管理和计算机软件保证 (CSA) 的专业知识，在测试，文档或控制不足时，他很容易挑战技术团队。你还将帮助加强组织的软件品质框架，因为它发展到更敏捷的实践并支持未来与人工智能相关的软件开发和验证。此外，该职位为计算机系统，数字产品，数据完整性控制和在监管环境中运行的软件支持的业务流程提供质量和法规合规监督。此角色与信息技术 (IT),软件质量保证 (SQA) ,产品所有者，系统所有者和商业过程所有者密切合作，以确保计算机系统按照适用的监管要求，质量管理体系 (QMS) 期望以及风险管理原则实施，维护和治理。本职位作为独立的质量代表和合规顾问。责任：合规监督和保证：·通过定期内部审计提供计算机化系统和数字解决方案的独立质量和监管监督 •评估软件治理活动是否符合适用的监管要求和内部程序 •审查软件质量文件，以确保合规性和基于风险的决策 •评估计算机化的系统控制是否保持在整个系统生命周期中一致和有效：•参与数字和计算机化系统风险评估•评估监管，患者和/或
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POSITION SUMMARY:
NMDP is looking for a Senior Quality & Compliance Specialist to join our Quality & Regulatory Affairs team! In this role, the Senior Quality & Compliance Specialist will provide independent quality and regulatory oversight for computerized systems and digital solutions in a regulated environment. You’ll partner closely with IT and Quality teams to evaluate SDLC practices, establish routine software auditing, assess risk, and proactively identify compliance gaps before they become inspection findings. This role is ideal for an experienced software quality professional with expertise in regulated SDLC, internal auditing, Quality Management Systems, Quality Risk Management, and Computer Software Assurance (CSA) who is comfortable challenging technical teams when testing, documentation, or controls fall short. You’ll also help strengthen the organization’s software-quality framework as it evolves toward more Agile practices and supports future AI-related software development and validation.
Additionally, this role provides quality and regulatory compliance oversight for computerized systems, digital products, data integrity controls, and software-enabled business processes operating within regulated environments. This role partners closely with Information Technology (IT), Software Quality Assurance (SQA), Product Owners, System Owners, and Business Process Owners to ensure that computerized systems are implemented, maintained, and governed in accordance with applicable regulatory requirements, quality management system (QMS) expectations, and risk management principles.
This position serves as an independent quality representative and compliance advisor. The role does not own software development, system implementation, validation execution, testing activities, or the software development lifecycle (SDLC).
ACCOUNTABILITIES:
Compliance Oversight and Assurance:
- Provide independent quality and regulatory oversight of computerized systems and digital solutions through routine internal audits
- • Evaluate whether software governance activities align with applicable regulatory requirements and internal procedures
- • Review software quality documentation for compliance adequacy and risk-based decision making
- • Assess whether computerized system controls remain compliant and effective throughout the system lifecycle
Quality Risk Management:
- Participate in digital and computerized system risk assessments
- • Evaluate regulatory, patient, and/or product quality risks associated with software-enabled processes and escalate as necessary
- • Ensure risk assessments appropriately consider:
o Data integrity
o Electronic records
o Electronic signatures
o Regulatory reporting impacts
o GxP process impacts
o Supplier
• Provide independent review of mitigation strategies
• Promote adoption of risk-based compliance practices
Regulatory and QMS Alignment
- Ensure internal procedures and governance models remain aligned with evolving regulatory expectations
- • Partner with process owners to incorporate compliance requirements
- • Promote application of ALCOA+ principles throughout computerized systems
- • Review proposed process changes for potential impacts to validated state of software systems
- • Participate in assessments of software suppliers and service providers
- • Support software supplier qualification and periodic evaluation processes
- • Participate/Lead quality investigations involving software-related deviations, complaints, CAPAs, audit observations, and data integrity concerns
REQUIRED QUALIFICATIONS:
Knowledge of:
- 21 CFR Part 11, 21 CFR 1271 and 211
- • Computer Software Assurance
- • Quality Risk Management (ICH Q9, ISO 14971, 9001)
- • GAMP 5 principles
- • Internal Auditing
- • Quality Management Systems
• Regulatory inspection practices
Ability to:
- Collaborate with diverse teams and influence stakeholders through excellent communication and strong interpersonal skills
- • Leverage risk-based decision-making skills to drive optimization
• Influence without authority
- Lead audits, inspections or major quality initiatives
Education and/or Experience:
- Bachelor’s degree in Science, Engineering, Quality, Computer Science, IS, Regulatory Affairs, or related field. However, upon evaluation, equivalent experience, or related education in addition to the required experience may be substituted for the specific degree requirements.
- • 5+ years in Quality, Regulatory Affairs, Compliance, Computer System Validation (CSV/CSA), Software Quality Assurance or Engineering, or related regulated industry experience.
PREFERRED QUALIFICATIONS:
- Experience working in FDA, GxP, biologics, pharmaceutical, cell therapy, blood banking, medical device or healthcare regulated environments.
Originally posted on Himalayas