Sanofi

QA Senior Compliance Specialist, Night Time Operations

Sanofi

Framingham, MA, USA
Full-TimeDepends on ExperienceMid-LevelBachelors
Job Description

Are you a highly skilled and experienced Quality Assurance professional with a passion for ensuring compliance in the pharmaceutical industry? Do you thrive in a fast-paced and dynamic work environment? If so, we have an exciting opportunity for you at Sanofi as a QA Senior Compliance Specialist for our Night Time Operations team. In this role, you will be responsible for ensuring the highest level of quality and compliance in our manufacturing processes during the night shift. We are seeking a detail-oriented and proactive individual with a strong background in quality control and regulatory compliance. If you have a proven track record of success in this field and are looking for a new challenge, we encourage you to apply for this position. Join our team and make a positive impact on the lives of patients worldwide.

  • Develop and maintain a thorough understanding of all relevant regulations, guidelines, and standards for pharmaceutical manufacturing.
  • Monitor and evaluate compliance with quality standards and regulations during night time operations.
  • Identify and communicate potential compliance issues to management and provide recommendations for resolution.
  • Conduct quality audits and reviews of manufacturing processes and documentation to ensure compliance.
  • Collaborate with cross-functional teams to implement corrective and preventive actions for any identified compliance issues.
  • Train and educate employees on quality and compliance standards to promote a culture of continuous improvement.
  • Participate in the development and maintenance of quality systems and procedures to ensure compliance with regulatory requirements.
  • Assist in the preparation and submission of regulatory filings and responses to inspection findings.
  • Keep up-to-date with industry trends and changes in regulations to ensure compliance of the night time operations.
  • Act as a subject matter expert on compliance-related matters and provide guidance to team members.
  • Represent the company during regulatory inspections and audits, ensuring all necessary documentation is readily available.
  • Continuously assess and improve quality and compliance processes to promote efficiency and effectiveness within the night time operations team.
  • Communicate regularly with management on compliance status, issues, and potential risks.
Where is this job?
This job is located at Framingham, MA, USA
Job Qualifications
  • Bachelor's Degree In A Science Or Healthcare Related Field, Such As Chemistry, Pharmacy, Or Biology.

  • Minimum Of 5 Years Experience In A Quality Assurance Role Within The Pharmaceutical Industry.

  • In-Depth Knowledge Of Fda Regulations, Including Cgmp, Glp, And Gcp.

  • Experience With Conducting Audits And Inspections Of Manufacturing Facilities And Ensuring Compliance With Regulatory Requirements.

  • Strong Communication And Leadership Skills, With The Ability To Effectively Train And Mentor Junior Team Members.

Required Skills
  • Quality Assurance

  • Process Improvement

  • Data Analysis

  • Auditing

  • Quality Control

  • Team Leadership

  • Compliance Management

  • Risk assessment

  • Time

  • SOP Development

  • Regulatory Knowledge

  • Gmp Standards

Soft Skills
  • Communication

  • Conflict Resolution

  • Customer Service

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a QA Senior Compliance Specialist, Night Time Operations in Framingham, MA, USA is $80,000 - $105,000 per year. However, this can vary depending on factors such as experience, qualifications, and company size. Some companies may offer higher salaries and additional benefits for this position.

Additional Information
Sanofi is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedMarch 20th, 2025
Apply BeforeMay 22nd, 2025
This job posting is from a verified source. 

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About Sanofi

Sanofi SA is a French multinational pharmaceutical company headquartered in Paris, France, the world's fifth-largest by prescription sales. Building a More Equitable Future through Inclusive Clinical Trials · Rethinking the science of COPD · Grassroots Manufacturing Solutions for a Healthier Planet.

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