Sanofi US
Manager, Quality Operations - Vaccine
Sanofi US, Waltham, Massachusetts, United States, 02254
Overview
Job title:
Manager, Quality Operations - Vaccine Location:
Waltham, MA About the job The Manager of Quality Operations ensures internal and external compliance to Sanofi’s Standard Operating Procedures and that current industry standards have been met throughout the development life cycle of Sanofi’s products. This position provides leadership and direction to the Operational Quality team and influences the Quality mindset across the organization. This is a Manager level position reporting directly to the Head of Quality. We are an innovative global healthcare company delivering vaccines to protect public health. Our teams explore new technologies to advance science and improve patient outcomes.
Responsibilities Partner with Analytical Development, QC, Internal/External Manufacturing and Quality Operations to strategically develop and implement a phase-appropriate approach to quality assurance and quality systems.
Proactively communicate key issues and critical topics to the appropriate management level and relevant project team members in a timely manner.
Assist in developing strategic plans to meet Quality KPIs and coach front-line managers in quality-related decision making.
Establish and maintain phase-appropriate cGMP compliance for product manufacturing, testing and stability; oversee review and approval of master production records, executed production records, in-process and release testing, specifications, reference materials, and test results.
Serve as Quality Assurance for documentation generated during CoE Raw Materials, QC Lab, and Manufacturing support, including the Stability program (not including Batch Release activities).
Provide quality oversight for external manufacturing of Lipids, Enzymes, pDNA and master cell banks.
Build and manage Quality relationships with CDMOs, including periodic CDMO visits and representing Sanofi QA on project teams.
Harmonize Ways of Working between the Waltham and France Center of Excellence facilities to align a common approach to Operational Excellence.
Establish and track Quality metrics, engaging with internal and external stakeholders and communicating issues to senior management for resolution.
Ensure adherence to US, global regulatory authorities and Sanofi Global Standards for research, development and commercial activities.
Maintain quality governance and continuously improve governance to meet business and compliance needs; provide guidance to ensure ongoing compliance across the operational team.
Establish strong working relationships with external manufacturers (CDMOs) and align Quality Systems; resolve discrepancies and non-compliance events through investigations and risk assessments.
Communicate significant quality risks that may impact product suitability or regulatory compliance to the Head of Quality and key stakeholders.
Review and edit Quality Technical Agreements, contracts, and supplier agreements to provide quality input to project plans and statements of work.
Work cross-functionally on discovery and development teams and with line functions to ensure awareness and compliance with quality/regulatory requirements.
Collaborate with business partners to enable task execution within the broader Sanofi organization.
Support and improve processes and SOPs in areas such as Deviations/Investigations, CAPAs, Change Control, and the Inspection Readiness Program.
Support and improve internal and external Audit schedules/programs.
Promote a quality mindset in GxP operational areas with risk-based and innovative decision-making.
Evaluate and implement corrective and preventative actions for systemic issues.
Motivate and coach the Quality Operations team to achieve quality delivery and customer satisfaction.
Lead by example to uphold high standards of quality and compliance.
Develop and maintain strong relationships with internal and external stakeholders to optimize Quality Operations performance.
Review and update company records, including Policies/SOPs, performance reviews, and risk assessments.
Qualifications Earned Bachelor's degree (required; Master’s preferred) in a STEM discipline.
Pharmaceutical/biotechnology experience (12+ years) with at least 10 years in a Quality function (Quality Assurance preferred).
Experience in US, EU and ICH GMP requirements, including reviewing submission documentation and responses to regulatory inquiries and inspections.
Strategic experience with senior leadership and strong decision-making accountability.
Expert knowledge in data analysis, reporting, and trending.
Proven ability to lead organization-wide operational excellence initiatives; experience with outsourced manufacturing and testing is a plus.
Strong leadership in a matrix environment; excellent written and verbal communication and negotiation skills.
Ability to influence across functions and work without direct authority; capable of operating in a fast-paced environment.
Collaborative, team-oriented, independent, detail-focused with strong problem-solving and time management skills.
Why Choose Us? Contribute to bringing the miracles of science to life with a supportive team.
Opportunities for growth and advancement, including international opportunities.
Rewards package that recognizes contribution and impact.
Comprehensive health and wellbeing benefits, including at least 14 weeks of gender-neutral parental leave.
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 or domestic partner status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, or other protected characteristics.
Pursue progress, discover extraordinary. Better is out there. Better medications, better outcomes, better science. Progress happens when people from diverse backgrounds come together to make miracles happen. Sanofi provides equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
US and Puerto Rico Residents Only
The salary range for this position is $108,750.00 - $181,250.00. All compensation will be determined commensurate with demonstrated experience. Additional benefits information can be found through the company.
#J-18808-Ljbffr
Job title:
Manager, Quality Operations - Vaccine Location:
Waltham, MA About the job The Manager of Quality Operations ensures internal and external compliance to Sanofi’s Standard Operating Procedures and that current industry standards have been met throughout the development life cycle of Sanofi’s products. This position provides leadership and direction to the Operational Quality team and influences the Quality mindset across the organization. This is a Manager level position reporting directly to the Head of Quality. We are an innovative global healthcare company delivering vaccines to protect public health. Our teams explore new technologies to advance science and improve patient outcomes.
Responsibilities Partner with Analytical Development, QC, Internal/External Manufacturing and Quality Operations to strategically develop and implement a phase-appropriate approach to quality assurance and quality systems.
Proactively communicate key issues and critical topics to the appropriate management level and relevant project team members in a timely manner.
Assist in developing strategic plans to meet Quality KPIs and coach front-line managers in quality-related decision making.
Establish and maintain phase-appropriate cGMP compliance for product manufacturing, testing and stability; oversee review and approval of master production records, executed production records, in-process and release testing, specifications, reference materials, and test results.
Serve as Quality Assurance for documentation generated during CoE Raw Materials, QC Lab, and Manufacturing support, including the Stability program (not including Batch Release activities).
Provide quality oversight for external manufacturing of Lipids, Enzymes, pDNA and master cell banks.
Build and manage Quality relationships with CDMOs, including periodic CDMO visits and representing Sanofi QA on project teams.
Harmonize Ways of Working between the Waltham and France Center of Excellence facilities to align a common approach to Operational Excellence.
Establish and track Quality metrics, engaging with internal and external stakeholders and communicating issues to senior management for resolution.
Ensure adherence to US, global regulatory authorities and Sanofi Global Standards for research, development and commercial activities.
Maintain quality governance and continuously improve governance to meet business and compliance needs; provide guidance to ensure ongoing compliance across the operational team.
Establish strong working relationships with external manufacturers (CDMOs) and align Quality Systems; resolve discrepancies and non-compliance events through investigations and risk assessments.
Communicate significant quality risks that may impact product suitability or regulatory compliance to the Head of Quality and key stakeholders.
Review and edit Quality Technical Agreements, contracts, and supplier agreements to provide quality input to project plans and statements of work.
Work cross-functionally on discovery and development teams and with line functions to ensure awareness and compliance with quality/regulatory requirements.
Collaborate with business partners to enable task execution within the broader Sanofi organization.
Support and improve processes and SOPs in areas such as Deviations/Investigations, CAPAs, Change Control, and the Inspection Readiness Program.
Support and improve internal and external Audit schedules/programs.
Promote a quality mindset in GxP operational areas with risk-based and innovative decision-making.
Evaluate and implement corrective and preventative actions for systemic issues.
Motivate and coach the Quality Operations team to achieve quality delivery and customer satisfaction.
Lead by example to uphold high standards of quality and compliance.
Develop and maintain strong relationships with internal and external stakeholders to optimize Quality Operations performance.
Review and update company records, including Policies/SOPs, performance reviews, and risk assessments.
Qualifications Earned Bachelor's degree (required; Master’s preferred) in a STEM discipline.
Pharmaceutical/biotechnology experience (12+ years) with at least 10 years in a Quality function (Quality Assurance preferred).
Experience in US, EU and ICH GMP requirements, including reviewing submission documentation and responses to regulatory inquiries and inspections.
Strategic experience with senior leadership and strong decision-making accountability.
Expert knowledge in data analysis, reporting, and trending.
Proven ability to lead organization-wide operational excellence initiatives; experience with outsourced manufacturing and testing is a plus.
Strong leadership in a matrix environment; excellent written and verbal communication and negotiation skills.
Ability to influence across functions and work without direct authority; capable of operating in a fast-paced environment.
Collaborative, team-oriented, independent, detail-focused with strong problem-solving and time management skills.
Why Choose Us? Contribute to bringing the miracles of science to life with a supportive team.
Opportunities for growth and advancement, including international opportunities.
Rewards package that recognizes contribution and impact.
Comprehensive health and wellbeing benefits, including at least 14 weeks of gender-neutral parental leave.
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 or domestic partner status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, or other protected characteristics.
Pursue progress, discover extraordinary. Better is out there. Better medications, better outcomes, better science. Progress happens when people from diverse backgrounds come together to make miracles happen. Sanofi provides equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
US and Puerto Rico Residents Only
The salary range for this position is $108,750.00 - $181,250.00. All compensation will be determined commensurate with demonstrated experience. Additional benefits information can be found through the company.
#J-18808-Ljbffr