What are the responsibilities and job description for the Regulatory Compliance Manager position at Lexis Nexis?
About our Team
LexisNexis Reed Tech brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our Reed Tech suite of SingleSource™ for Medical Devices, SingleSource™ for Drug Products, and Navigator™ for Drug Labels enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind. For more information, please visit
www.reedtech.com
About the role
The Senior Manager, GxP Quality Systems, is responsible for overseeing and enhancing the Quality Management System (QMS) to ensure compliance with Good Practice (GxP) regulations, including Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP). This role involves leading quality assurance operations, managing internal and external audits, and collaborating with cross-functional teams to maintain the highest quality standards.
Responsibilities:
- Quality Management System Oversight: Develop, implement, and maintain the QMS in alignment with GxP regulations, ISO and industry standards.
- Audit Management: Lead internal audits to assess compliance with Standard Operating Procedures, ISO 13485, 9001, 27001 and other relevant regulations; host external audits and demonstrate QMS compliance to clients and regulatory bodies.
- Regulatory Compliance: Stay abreast of current and emerging regulations impacting medical devices and combination products; ensure organizational adherence to these regulations.
- Issue Resolution: Lead investigations into product and service quality issues, deviations, and non-conformances; implement effective corrective and preventive actions (CAPAs).
- Supplier Quality Management: Oversee supplier qualification, audits and monitoring programs, and manage relationships with contract suppliers.
- Continuous Improvement: Analyze quality system, product, and services performance metrics; lead quality process improvement initiatives to continuously enhance efficiency and effectiveness.
- Training and Mentorship: Provide guidance and training to quality assurance staff and other departments on quality system processes and regulatory requirements.
- Training Curriculum and Compliance: Establish compliance training curriculum for departments (e.g. Development, Product, Services, Support, etc.) to ensure staff is trained on their role to ensuring compliance with controlled policies and procedures
- Documentation Review: Author/Approve applicable Standard Operating Procedures (SOPs), Work Instructions (Wis), and Computer System Validation (CSV) Protocols and respective test scripts and reports.
- Change Management: manage change requests, risk assessments, approvals, and monitoring of artifact generation and collection required to maintain compliance with SOPs, SDLC, and CSV procedures from request to release.
Qualifications:
- Education: Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or a related field; advanced degree preferred.
- Experience: Minimum of 8 years in a GxP-regulated environment, with at least 3 years in Quality Assurance Operations Management.
- Certifications: ISO 13485 Lead Auditor certification required; additional certifications (e.g., Six Sigma Black Belt, PMP) are advantageous.
- Experience with Agile methodologies (Scrum/Kanban); ability to partner with Product and Engineering to influence roadmap and processes.
- Technical Proficiency: Strong understanding of GxP regulations, ISO standards, and quality assurance principles.
- Skills: Excellent problem-solving, project management, and communication skills; ability to lead cross-functional teams and manage complex projects.
- Regulatory Knowledge: Experience with FDA and EU regulations pertaining to GxP manufacturing activities.
Work in a way that works for you
Working flexible hours - flexing the times when you work in the day to help you fit everything in and work when you are the most productive. We promote a healthy work/life balance across the organization. We offer an appealing working prospect for our people. With numerous wellbeing initiatives, shared parental leave, study assistance and sabbaticals, we will help you meet your immediate responsibilities and your long-term goals.
Working for you
We know that your wellbeing and happiness are key to a long and successful career. These are some of the benefits we are delighted to offer:
- Health Benefits: Comprehensive, multi-carrier program for medical, dental and vision benefits
- Retirement Benefits: 401(k) with match and an Employee Share Purchase Plan
- Wellbeing: Wellness platform with incentives, Headspace app subscription, Employee Assistance and Time-off Programs
- Short-and-Long Term Disability, Life and Accidental Death Insurance, Critical Illness, and Hospital Indemnity
- Family Benefits, including bonding and family care leaves, adoption and surrogacy benefits
- Health Savings, Health Care, Dependent Care and Commuter Spending Accounts
- Up to two days of paid leave each to participate in Employee Resource Groups and to volunteer with your charity of choice
LexisNexis, a division of RELX, is an equal opportunity employer: qualified applicants are considered for and treated during employment without regard to race, color, creed, religion, sex, national origin, citizenship status, disability status, protected veteran status, age, marital status, sexual orientation, gender identity, genetic information, or any other characteristic protected by law. We are committed to providing a fair and accessible hiring process. If you have a disability or other need that requires accommodation or adjustment, please let us know by completing our Applicant Request Support Form:
https://forms.office.com/r/eVgFxjLmAK
, or please contact 1-855-833-5120.
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