Compliance Specialist / Audit And Inspection Lead at Sanofi Aventis US LLC

Miskolc, North Hungary, Hungary -

Full Time

Start Date

Immediate

Expiry Date

13 Mar, 26

Salary

0.0

Posted On

13 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Compliance, Audit Management, Regulatory Inspections, Pharmaceutical Regulations, Training, Documentation, Risk Mitigation, Continuous Improvement, Corrective Actions, Communication, Attention to Detail, Project Management, Self-Inspection, Good Manufacturing Practices, Data Analysis, Incident Investigation

Industry

Pharmaceutical Manufacturing

Description

Job title: Compliance Specialist / Audit And Inspection Lead Location: Csanyikvölgy, Miskolc Hiring Manager: Balázs Kepiro Job Type: Fixed term, full-time Main Accountabilities Contributing to the development and maintenance of an effective compliance program Ensuring all operations comply with relevant regulatory requirements and other international standards Providing training and guidance to employees on compliance-related topics Maintaining compliance-related documentation, ensuring accuracy and completeness Identifying potential compliance risks and contributing to the development of strategies to mitigate them Supporting the investigation and reporting of compliance incidents Managing CAPA to address compliance incidents and preventing recurrence Contributing to continuous improvement initiatives to enhance compliance processes and systems Preparing and participating in internal and external audits and regulatory inspections Developing and implementing an annual self-inspection plan Reviewing the internal audit reports before submission to senior management to ensure accuracy and consistency Ensuring an inspection readiness process is in place to manage announced and unannounced inspections Leading and managing regulatory inspections and audits Identifying near misses during inspections and recommending corrective actions · Reviewing inspection outcome and contributing to the answers Monitoring the implementation of corrective and preventive actions (CAPAs) related to audit and inspection Representing the site in the CoP, could be a member of the CoE, and ensuring local communication Key roles (D,A,I) · Support management on compliance topics (A) · Review the relevance of remediation action from findings from internal and external audits related to health-related topics (A) · Advise on improvements to compliance processes and systems (A) · Advise on risk mitigation strategies (A) · Advise on corrective actions for compliance incidents (A) · Advise on continuous improvement initiatives (A) Coordinate quality alert and batch recall process with global team (A) · Decide on the structure and timing of internal audit plans and schedules, based on risk assessment (D) · Advise on corrective actions for identified non-compliance issues (A) · Monitor and track actions for near misses in the database (I) Track and inform relevant stakeholders about the status of CAPA implementation (I) Expected Experience · Experience in ensuring compliance with local, national, and international pharmaceutical regulations and standards · Experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow-up · 5 years of experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow-up Expected Technical skills · In-depth understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH) · Ability to analyze complex compliance issues, identify root causes, and develop effective solutions · Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders · Proficiency in managing multiple compliance projects simultaneously, ensuring timely completion and adherence to standards · Keen attention to detail to ensure accuracy in compliance documentation, audits, and reports · Ability to analyze complex data and audit findings to identify compliance issues and recommend corrective actions · Meticulous attention to detail to ensure accuracy in audit reports, documentation, and compliance assessments · Strong verbal and written communication skills to effectively liaise with regulatory bodies, present findings to senior management, and train staff · Proficiency in managing multiple audits and inspections simultaneously, including planning, scheduling, and coordinating with various departments In-depth understanding of pharmaceutical regulations and standards, including Good Manufacturing Practices (GMP) and other relevant guidelines Language Fluent in Hungarian and English (written and spoken) About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Why choose us? · Join a leading pharmaceutical company and contribute to improving health outcomes worldwide. · Be part of a company at the forefront of medical research and breakthrough therapies. · Thrive in an environment that values diversity of thought and background. · Work closely with global and local teams, gaining exposure to various aspects of the pharmaceutical business. #LI-EUR Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The Compliance Specialist will contribute to the development and maintenance of an effective compliance program, ensuring operations comply with regulatory requirements. They will also manage internal and external audits and regulatory inspections, providing training and guidance to employees on compliance-related topics.