Manager Inspection - Vaccine

Summary of purpose/major responsibilities

The Visual Inspection Manager provides leadership for the Fill and Inspection department by directing, planning and overseeing the inspection operations. This position ensures that permanent as well as temporary personnel are compliant and meet the regulatory requirements. This includes leading programs to improve employee safety, improve product quality, efficiencies, reduce costs, and increase employee engagement in accordance with company established goals and objectives. This position also plays a key role in the development of others for the purpose of creating a strong workforce of the future.

Key Accountabilities

• Staff coaching and development

• Shop floor supervision

• Production quality including deviation investigations & CAPA

• Planning and scheduling

• Document creation & reviewing

• Projects & project supports

Context of the Job/Major challenges

Assures that operations are conducted in compliance with procedures and regulatory agencies.

Understanding of cGMP activities, campaigns, scheduling, and logistics.

Develops and leads a high-performance team; owns the recruitment, training and staff development.

Dimensions/Scope

The responsibilities are, but not limited to:

Safety:

• Follows up on observations for HSE8 metric

• Ensures a safe work environment for employees

Quality:

• In Process reviews batch records for correctness and completeness

• Supervises and coaches permanent and temporary staff to adherence to procedures and guidance.

• Perform preliminary deviation investigations

Delivery:

• Assures that operations are conducted in compliance with plant procedures and regulatory agencies.

• Supervises activities including cGMP manufacturing, campaigns, scheduling, logistics, document creation and review.

• Participates in planning and development of production schedules, coordinating personnel activities for commercial production and tech transfers

• Ensures adherence to monthly production schedule for the process area including the ability to drive enhancements and improvements necessary to optimize capacity utilization

• Ensures all projects impacting the shop floor are executed properly, attaining desired outcomes on schedule and quality standards

• Drives delivery of production schedule by maximizing shift productivity.

Cost:

• Exhibits a strong sense of overall business ownership by determining the operational impacts caused by production issues

• Defines mitigation plans with cross functional groups to minimize customer impacts

• Takes a role in implementing new equipment and procedures including coordinating activities with maintenance, metrology, manufacturing technology, and validation.

Involvement:

• Builds effective partnerships with other departments and support group to help drive the business toward achieving company objectives.

• Participates in Level 1 QDCI boards

• Leads shift changes between shifts and with other managers

• Professionally and appropriately interacts and communicates with internal clients to fully represent the technical, logistical, and risk management aspects of production.

• Utilizes available assets to reduce waste and maximize throughput.

Develop People:

• Develops and leads a high-performance team; owns recruitment, training, and development of staff

• Responsibilities include employee selection, training, development, counseling, recommendations for cost reductions, profit improvement opportunities, cost control, quality of product, incident investigations, managing departmental capital and operations budgets.

• Managerial coverage as required for all shift working hours including weekends and holidays.

REQUIREMENTS

Education/experience

• High School Diploma with minimum of five (5) years of relevant experience in manufacturing, quality control, or process development.

• Bachelors Degree with minimum of three (3) years of relevant experience in manufacturing, quality control, or process development.

• Minimum of three (3) years of leading teams.

• Root cause investigation principles

• Knowledge of lean manufacturing principles

• Technical writing including proficient in Microsoft Office (Excel, Work, and PowerPoint)

• Strong time management and prioritization skills

• Strong problem solving and decision-making skills including the ability to analyze complex situations involving the competing objectives of cost and quality.

• Preferred: A sound understanding of automated and semi-automated equipment inspection of liquid and lyo products.

• Preferred: Knowledge of ERP system (SAP preferred)

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.

According to the CDC, an individual is considered to be fully vaccinated fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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.

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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.