Deputy Director Quality Systems FFIP - Vaccine

Deputy Director FFIP Quality SystemsDevelop and lead a PI team by coordinating the assignment of work to support deviations and overseeing on-time closure of investigations to meet site performance metrics and product release. Drive productive changes across the FFIP platform for the benefit of deviation reduction and increased efficiency in cycle time. Support the site for all internal and external audits and regulatory inspections. Serve as the Deputy Director for Quality Systems while interfacing with multiple cross functional teams and effectively communicating progress and updates across multiple levels of the organization.THE JOB RESPONSIBILITIES INCLUDE:Drive for Results by coordinating the assignment and prioritization of tasks to support deviation investigations (facilitate roadblocks and escalate needs to support groups) and ensure on-time closure of each item to meet the site performance metrics and product release requirements.

Develop and lead an agile Principal Investigator’s team that can respond to a wide variety of demands while respecting the company core values and culture.

Serve as a subject matter expert on systems required to complete thorough investigations, changes, and drive improvements across FFIP.

Help to create a continuous improvement culture and drive projects for process improvements for the benefit of deviation reduction and increased efficiency in cycle time. Participate and support participation in cost reduction initiatives.

Effectively and accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.

Support the site for all internal and external audits and regulatory inspections and responsible for defending deviation investigation write-ups, including investigations written by other investigators.

Review deviations for completeness written by Principal Investigators and perform Manager or Director review of minor and major events prior to the review by Quality Assurance.

Provide routine coaching for improvements and own the training process and mentoring of junior staff.

Ability to make risk-based decisions in a dynamic setting. Manage multiple high-profile priorities independently to meet key deadlines and accurately communicate escalation of roadblocks to upper management.

Ensure all Quality System operations are conducted in compliance with cGMP’s.

Must be able to work extended and flexible hours (including weekends) when needed.

KEY COMPETENCIES:Behaves according to company values and competencies

Encourages and ensures proactive and strong collaboration internally and across VIA functions; forward thinking with an attitude of optimization, and efficiency

Collaborate cross functionally, to develop and implement changes, by participating in project teams to facilitate deviation reduction and continuous improvement

Proactively anticipates and effectively communicates successes, constraints, conflicts, solutions and actions for resolution

Proactively resolves conflicts, removes roadblocks to execution within sphere of influence; escalates to functional management when appropriate.

Ability to problem solve and demonstrate critical thinking

Empower and ensure accountability within team

QUALIFICATIONS:Bachelor's Degree in life sciences or engineering, or equivalent

5-10 years' experience in a cGMP controlled/pharmaceutical industry

5+ years' experience in a regulated Quality environment is required

Previous leadership experience is required

2-5 years management experience related role in a similar industry is preferred

Excellent communication and interpersonal skills

Must be able to work extended and flexible hours (including weekends) when needed

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.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.#GD-SP#LI-SPAt 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.