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Quality Assurance Manager, Patient Services

Cambridge, Massachusetts

Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.

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  • HEALTH AND WELLNESS PROGRAMS

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  • FAMILY SUPPORT

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  • PAID TIME OFF

    Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!

  • WORK/LIFE BALANCE

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Responsibilities

Job Title: Patient Services Quality Assurance Manager

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with eight growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, rare blood disorders, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).  Sanofi-Genzyme, a division of Sanofi, is dedicated to making a major positive impact on the lives of people with serious diseases.

Summary

The Patient Services Quality Assurance Manager is responsible for the Rare Blood Disorder Patient Services quality monitoring program and ensures that all Rare Blood Disorder Patient Programs comply with Sanofi pharmacovigilance reporting and monitoring requirements.

The position liaises directly with Sanofi pharmacovigilance and will interface with a multidisciplinary team to include patient services case management, pharmacovigilance, product quality, patient services analytics and commercial operations IT.

Job Responsibilities

  • Liaises directly with Sanofi Pharmacovigilance and Quality to ensure alignment with global Patient Program requirements
  • Implements global Sanofi pharmacovigilance governance procedures for tracking and monitoring Rare Blood Disorder Patient Programs
  • Conducts monthly PV data reconciliation and quality control checks for all potential sources of PV data
  • Creates and maintains local pharmacovigilance related SOPs and work instructions for internal employees and external suppliers for all RBD Patient Services Patient Programs
  • Develops training materials, conducts training and tracks compliance with Rare Blood Disorders Patient Program specific pharmacovigilance SOPs and work instructions
  • Responsible for the Rare Blood Disorders Case Management Quality Monitoring program to include program design, measurement criteria, execution and reporting of patient service associates interactions with patients and providers
  • Reviews, rates and coaches the patient services associates performance in handing inbound and outbound phone calls ensuring adherence to established quality metrics in support of a superior patient and provider experience
  • Conducts case audits ensuring record completeness, proper dispositioning, required documentation attached and appropriateness of call notes
  • Partners with Sanofi compliance in the monitoring of interactions with patients and healthcare professionals
  • Ensures partnered programs have quality programs and appropriate controls in place to ensure a continuously compliant and high-quality operation

Qualifications

Education:

  • Associate's degree in a scientific, allied health field, business or related field required
  • Advanced degree preferred

Experience:

  • Minimum of 5+ years of progressive experience serving in a Quality role in the pharmaceutical/biotechnology or related industry
  • 2+ years’ experience with operational and agent level quality programs designed to evaluate, improve, and elevate the patient and provider experience
  • Strong knowledge and experience in auditing and inspections, including development of responses.
  • Prior experience in the management, development and implementation of a risk-based global PV & QA Audit program in support of clinical safety and pharmacovigilance activities.
  • Advanced knowledge of quality management systems, including systematic approaches to process improvement required.
  • Knowledge regarding the use of electronic systems in a regulated environment, including those implemented in support of drug safety, training oversight, and documentation management
  • Prior REMS experience a strong plus
  • Experience with Customer Relationship Management (CRM) systems (Salesforce, Veeva, etc.) strongly preferred
  • Proven history of working collaboratively in multidisciplinary teams.

Travel:

  • Domestic travel less than 10%

Genzyme Corporation (a Sanofi company) and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce.  All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#LI-GZ

#GD-SG

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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