Sanofi Group Quality Principal: ROTATING 12 HR SHIFT DAYS 7AM-7PM, Allston, MA in Allston, Massachusetts
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs:
Demonstrate an ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Acting with integrity and treating people with respect and courtesy.
Constantly striving to make Sanofi Genzyme a great place to work, and a company respected for the quality of its people and products.
Act as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgement in performing our jobs.
This position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP's. The responsibilities include but are not limited to:
Perform record issuance and review to ensure the compliance of manufacturing procedures to in-house specifications and government regulations on the manufacturing floor and ensuring on-the-floor presence of QA.
Conduct review of manufacturing processes to ensure compliance.
Conduct review of testing results in support of release of intermediates.
Provide compliance guidance and direction to QA and manufacturing support teams.
Lot/ Intermediate Disposition Responsibilities:
Participate in bulk shipment oversight activities.
Participate in Quality release activities of manufactured intermediates.
Deviation/CAPA Management Responsibilities:
Work closely with manufacturing groups to support all deviations within agreed timelines.
Complete the OJT for All deviation classifications for investigating deviations within the QA cost center.
Perform deviation investigation activities, including; GEMBA, containment, classification and initial impact assessment.
Perform deviation/nonconformance investigations. May act as team lead to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution.
Work closely with manufacturing and support groups to develop effective CAPA to reduce deviation reoccurrence and for continuous improvement.
Perform deviation review to ensure compliance of investigations to in-house specifications and government regulations.
Perform final impact assessments to determine potential impact to product SISPQ to internal and external requirements.
May provide compliance guidance and direction to QA and Manufacturing support teams.
May approve management activities in Quality Management systems (ie. Trackwise/Phenix).
May facilitate department regulatory related CAPAs and audit responses.
May provide real time QA input to enable effective, compliant solutions to emerging issues in the manufacturing areas.
Quality Engineering Responsibilities:
Work with functional groups across the site to review and approve quality and technical documentation including deviations, CAPAs, Action Notices (AN), Change Control Requests (CCR), Documentation Change Requests (DCR), effectiveness reviews as well as associated documentation in support of Preventive/Correctiive Maintenance, Metrology, Automation Engineering and Validation.
Review unscheduled maintenance and facility alarms, specifically the return to service testing and assessing potential impact to product.
Provide support for visual inspections of vessel surfaces, when required.
Provide support for the development of robust maintenance procedures.
Review automation call/event logs to identify opportunities for training, process improvement and assess product impact.
Provide support to ensure automation changes are promptly removed to ensure system configuration and validation status are maintained.
Review, approve and act as owner of department controlled documents and processes ensuring compliance and adherence to requirements.
Provide support in developing training strategies and materials that supports continuous improvement of processes and provide to end users.
Participate in the QA consistency meetings to drive continuous improvement efforts
Participant in internal audits.
Participate in the QA consistency meetings to drive continuous improvement efforts.
Participant and/or lead in QA audit readiness program as well as assist and participant in external audits and regulatory inspections.
Participant in internal audits.
Participant in QA audit readiness program as well as assist and participant in external audits and regulatory inspections
Participant or may lead in Lean initiatives to improve Quality processes.
Effectively interact on a cross functional basis providing QA guidance at the area level and escalate any issues to Management in a timely fashion.
May act as a change owner for QA change controls.
May act as the change owner for QA document changes.
Ensure that department goals are achieved and on time Quality product is realized through execution of primary role in area of oversight (Batch Record Review, Deviation Management and/or Lot Disposition, etc.)
Comply with the requirements of Sanofi Genzyme's health and safety program
Master's degree and 4 years of experience, or Bachelor's degree and 6 years of experience, or Associate's degree and 8 years of experience or 6 years of experience in the BioTech / Pharmaceutical Industry .
Fully versed in CGMP, ICH, EMA and FDA rules, guidance and expectations.
Experience in on the job training and authoring SOPs.
Experience with using operational excellence tools to drive continuous improvement
Strong computer, verbal and written communication skills.
Strong technical writing skills.
Experience managing teams
Sanofi Inc. 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.
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.
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.
Sanofi, Empowering Life