Sanofi Group Operations Systems Support Manager - Vaccine in Pearl River, New York
*Day shift ( 7:00 AM to 3:30 PM) but with required flexibility to work off normal shift hours if necessary*
*Experience with investigations, technical writing, understanding and addressing deviations*
Contributes to the overall safety, quality, compliance, productivity and performance of the assigned Protein Sciences Manufacturing group. The Manager of Protein Science Manufacturing is responsible for ensuring deviations or CAPA, Change Controls, Documents and Internal Audit observations are completed on time to meet the site objectives. The Manager position will work to maintain consistency and standardized processes for training, labelling, production/personnel scheduling, performance monitoring, error tracking, documentation control, housekeeping, facility cleaning, daily mfg. release and overall compliance between all areas of Protein Sciences Mfg groups.
The role has the responsibility of back-up Shop Floor manager as needed and to support execution on the floor when required.
Ensure all Manufacturing operations are conducted in compliance with Health, Safety, Environment regulations.
Responsible for engaging, investigating and correcting departures from expectations to ensure the highest safety standards are maintained.
Q uality, Compliance, and Regulatory Inspections:
Ensure all Manufacturing operations are conducted in compliance with cGMP’s, safety regulations. Responsible to do the following:
Serve as SME for those items related to deviations or CC, CAPA, Documents and Audits, as appropriate.
Ensures quality systems items are written in a compliant manner and serves as reviewer/approver of those items as required.
Participates in the training process for new team members/processes.
Helps others work through issues and remove roadblocks regarding quality systems actions assigned to their team.
Helps manage the workload to meet the team's priorities.
D elivery, Supply, Operational Performance:
- Responsible for the associated Manufacturing function to ensure sufficient bulk product is released at the appropriate time and quality level to meet requirements for domestic, foreign and contracted vaccine sales.
C ost/Financial Performance:
- Participate and support cost reduction initiatives, as assigned.
Aide in the development of a highly trained organization that is able to respond to a wide variety of demands while respecting the company values and culture.
Ensure representation at Level 1 and/or Level 2 +QDCI boards and understand their connection to the Protein Sciences Level 3 boards.
Help to create a continuous improvement culture by supporting and leading projects for process improvements.
Strong leadership skills required to lead in a quality-focused manufacturing environment.
Strong cross-functional working skills to cut across boundaries within and outside Protein Sciences Manufacturing.
The scope of this role is Manufacturing within the Protein Sciences manufacturing sites.
This role is responsible for completing quality systems items that impact the timeliness and supply of compliant drug substance to US and international markets.
Headcount (direct and indirect) budget, doses, Capex, etc.
Serving as a leader in the associated functional group in Manufacturing to meet a demanding supply schedule while exceeding standards requires a high degree of flexibility and commitment.
Supervision of associated quality systems operations within one level of management is required. Decisions are made on complex matters involving short-term commitment of resources.
This position should be able to independently support, intermittently and in the short term, all activities in the Protein Sciences Manufacturing areas. Under minimal guidance, provides analysis and recommendations to management on all compliance systems related matters. Decisions must be made in a dynamic setting taking into account and balancing a changing business environment, business priorities, product and process deadlines and compliance issues. Must address internal and external regulatory requirements.
A Bachelors degree, preferably in Life Sciences or Engineering fields
4 or more year's industry experience with investigations, technical writing, understanding and addressing deviations
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.