Senior Analyst – Regulatory Compliance (Cambridge / Hybrid). This individual contributor role supports Illumina's global compliance framework through the execution and continuous improvement of compliance auditing and monitoring activities. The position focuses on performing compliance reviews, supporting audit preparation and execution, maintaining documentation, and tracking corrective actions. Operating in a highly matrixed, global environment, the incumbent partners with Legal, Compliance, Quality, Regulatory Affairs, and other business functions to monitor adherence to regulatory requirements and contribute to inspection readiness. Illumina’s employee benefits are industry‑leading and include flexible time off, private medical insurance, compassion and care time off, leisure travel insurance, pension, employee stock purchasing program, volunteer time off, and more.
Audit Execution & Support
* Support the planning and coordination of internal audits across functions and regions.
* Assist in developing audit schedules, scoping documentation, and test plans.
* Conduct interviews, gather evidence, and prepare workpapers to support audit conclusions.
* Evaluate audit findings, document observations, and assist in tracking corrective and preventive actions (CAPAs) through closure.
* Maintain organized audit records and ensure timely follow‑up with stakeholders.
Compliance Monitoring & Program Support
* Support the implementation and maintenance of Illumina’s Regulatory Compliance Program.
* Assist in monitoring compliance metrics, reporting results, and identifying trends or recurring issues.
* Contribute to updates of policies, procedures, and work instructions to ensure alignment with current regulatory standards.
* Assist in supporting other elements of Illumina’s Compliance Program efforts globally as called upon.
Inspection Readiness
* Maintain audit and inspection readiness documentation, ensuring accuracy and accessibility.
* Assist in the coordination of regulatory inspections and external audits (e.g., FDA, ISO, EU MDR).
* Support response preparation, document retrieval, and inspection logistics.
Continuous Improvement & Reporting
* Prepare and maintain compliance dashboards, reports, and summaries for management review.
* Identify opportunities to improve audit efficiency and consistency.
* Support compliance‑related training activities and knowledge sharing across teams.
Minimum Qualifications
* Bachelor’s degree in Life Sciences, Chemistry, Regulatory Affairs, or a related discipline.
* Experience in regulatory compliance, quality assurance, or internal audit in the biotechnology, pharmaceutical, or medical device industry.
* Working knowledge of global regulatory standards such as FDA QSR (21 CFR Part 820), ISO 13485, EU MDR, and GxP.
* Experience supporting internal or external audits, inspections, or compliance monitoring activities.
* Strong organizational, communication, and documentation skills.
* Experience with electronic Quality Management Systems (eQMS) or audit tracking tools.
* Familiarity with CAPA management and root cause analysis processes.
* Certification such as Certified Quality Auditor (CQA), Certified Internal Auditor (CIA), or Regulatory Affairs Certification (RAC) is a plus.
Other Requirements
* Flexible to work across multiple time zones as needed.
* Ability to travel domestically and internationally up to 10% of the time.
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero‑net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility.
Illumina is an equal‑opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
Closing date for applications: 17th December
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