Visual Inspection Mnager 2d shift

Sanofi•Swiftwater, PA

About The Position

The Manager, Visual Inspection Operations provides hands-on leadership and strategic oversight of visual inspection operations in a regulated vaccine manufacturing environment. The role is accountable for safety, quality, delivery, cost, and people performance, and fosters a culture of ownership, compliance, and continuous improvement. The manager applies technical knowledge of manual and automated inspection processes and industry best practices to strengthen systems, develop inspector capability, and improve operational efficiency. The position leads visual inspection operations on the second shift and drives right-first-time execution and inspection excellence across the shift. The role ensures adherence to safety procedures and supports safety meetings, walkthroughs, issue reporting, and corrective and preventive actions. It maintains compliance with cGMP, FDA, EU Annex 1, and other regulatory requirements; reviews batch records and inspection documentation; supports deviation investigations, audits, and regulatory inspections; and maintains inspection standards and audit readiness. The manager oversees production planning and scheduling to meet throughput and quality targets, adapts staffing to business needs, and drives efficiency, waste reduction, and process optimization. The position collaborates with Manufacturing, Quality, Engineering, and Supply Chain, supports automation initiatives, and recruits, trains, coaches, mentors, and manages the performance of inspectors and frontline leaders.

Requirements

  • High school diploma or equivalent.
  • At least 3 years of relevant experience in pharmaceutical or biologics manufacturing.
  • Demonstrated team leadership experience, including formal supervision or informal leadership such as directing work, coordinating activities, training, mentoring, or serving as a manager’s lead or designee.
  • Strong knowledge of cGMP requirements and quality systems.
  • Ability to drive accountability and performance improvement.
  • Experience leading root cause investigations and implementing corrective actions.

Nice To Haves

  • Bachelor’s degree in Life Sciences, Engineering, or a related field, or equivalent experience.
  • Experience leading visual inspection operations across multiple organizations or sites.
  • Proven success implementing process improvements that enhance efficiency, quality, or compliance.
  • Experience with automated or semi-automated inspection systems.
  • Knowledge of iSHIFT, eBR systems, or inspection management software.
  • Demonstrated success developing high-performing inspection teams.

Responsibilities

  • Lead visual inspection operations during the second shift and establish clear expectations and accountability across the team.
  • Follow and promote safety procedures; lead safety meetings, participate in safety walkthroughs, report safety issues and incidents, and contribute to corrective and preventive actions.
  • Ensure compliance with cGMP, FDA, EU Annex 1, and other regulatory requirements and procedures.
  • Review batch records and inspection documentation for accuracy and completeness.
  • Identify potential deviations, lead preliminary deviation investigations, and support root cause analysis and corrective actions.
  • Support internal and external audits and regulatory inspections, maintain inspection standards, and ensure audit readiness.
  • Oversee production planning and scheduling to meet throughput and quality targets, adjusting staffing to changing business volume and needs.
  • Drive efficiency improvements, waste reduction, and process optimization initiatives; apply industry benchmarks and best practices.
  • Lead or support automation initiatives for visual inspection systems.
  • Collaborate cross-functionally with Manufacturing, Quality, Engineering, and Supply Chain.
  • Maintain required training and support shift change activities.
  • Recruit, onboard, train, coach, develop, mentor, and manage the performance of inspectors and frontline leaders.
  • Foster engagement, ownership, accountability, and continuous improvement.
  • Perform other duties as assigned.

Benefits

  • Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
  • At least 14 weeks of gender-neutral parental leave.
  • Employees may be eligible to participate in company employee benefit programs.
  • Opportunities for career growth through promotion or lateral moves, domestically or internationally.
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