As a QA Senior Compliance Specialist at Sanofi, your primary responsibilities include collaborating with various departments to maintain cGMP compliance, reviewing critical documents such as batch records and cleaning logs, and representing QA during audits. You’ll also manage non-significant deviations and ensure quality support throughout the manufacturing processes, ultimately ensuring the safety and efficacy of our healthcare products.

To be eligible for the QA Senior Compliance Specialist role at Sanofi, candidates must possess a Bachelor's degree with at least 4 years of relevant experience, an Associate's degree with 6 years, or a High School diploma combined with 8 years of experience in a Quality or cGMP environment. Strong organizational and communication skills, along with proficiency in electronic document systems, are also essential.

Sanofi is dedicated to fostering career growth for its employees, including QA Senior Compliance Specialists. The company provides numerous opportunities for advancement, whether through promotions or lateral moves, both domestically and internationally. Furthermore, employees are encouraged to explore their interests and talents within a supportive and innovative environment.

A QA Senior Compliance Specialist at Sanofi will need to gown and enter cleanroom environments as part of their responsibilities. You'll also be actively engaged on the manufacturing floor, working collaboratively with other departments to address quality-related challenges while ensuring compliance with industry regulations.

Sanofi stands out as an employer due to its commitment to innovation in healthcare, the opportunity to work on impactful projects, and a robust rewards package that includes comprehensive health benefits and a strong emphasis on employee wellbeing. The company fosters a diverse and inclusive work culture, where all team members are encouraged to contribute their unique perspectives to achieve shared goals.

In the context of compliance, quality assurance means ensuring that all processes and products meet predefined standards and regulations. It involves proactive identification of potential issues and implementing measures to assure safety, efficacy, and quality in all operations, which aligns with the mission of a QA Senior Compliance Specialist at Sanofi.

Managing deviations in a QA environment involves investigating the root cause, implementing corrective actions, and ensuring thorough documentation. It's crucial to assess the impact of deviations on product quality and communicate effectively with key stakeholders, which is an important part of the QA Senior Compliance Specialist role at Sanofi.

My experience with cGMP compliance includes ensuring that all production processes adhere to regulatory standards. This entails regular audits, thorough documentation, and continuous training processes for team members to maintain the highest quality in operations, which is essential for the QA Senior Compliance Specialist role at Sanofi.

When conflicts arise with production teams over quality issues, I believe in open communication and collaborative problem-solving. It’s important to address the concern directly while seeking a mutually beneficial resolution. Building relationships based on trust and respect helps facilitate compliance discussions effectively.

One of my most significant achievements in a quality assurance role involved leading a team through a rigorous audit process where we successfully passed with no findings. This required extensive planning, coordination, and compliance efforts to ensure all documentation and processes were in order, showcasing my ability to uphold the standards expected of a QA Senior Compliance Specialist.

I approach training team members in compliance protocols with a focus on engagement and practical application. By using real scenarios and encouraging questions, I ensure that the training is interactive and tailored to the specific challenges we face in our QA processes at Sanofi.

I am proficient in various software tools for quality management, including Trackwise, Veeva, and Microsoft Office Suite, particularly Excel and Word. These tools have been invaluable in tracking compliance documentation and reporting within the QA aspects of my previous roles.

I am excited about the opportunity to work as a QA Senior Compliance Specialist at Sanofi because of the company's commitment to innovation and improving healthcare outcomes. The chance to contribute to meaningful work and be part of a collaborative team aligns perfectly with my professional aspirations and values.

Prioritizing multiple quality projects requires careful time management and effective communication with stakeholders. I assess the urgency and impact of each project, delegate tasks when possible, and utilize project management tools to stay organized, ensuring deadlines are met without compromising quality.

Preparing for an audit involves thorough review of all related documentation, conducting mock audits to identify potential issues, and ensuring that all team members are aware of what to expect. It’s crucial to have a clear communication plan in place to address questions during the audit, a key component for the QA Senior Compliance Specialist role.