About The Position

Provides strategic leadership and operational oversight of manufacturing quality systems, production planning, and manufacturing support functions within a GMP biopharmaceutical environment. Responsible for ensuring compliance, operational efficiency, and continuous improvement across three distinct functional teams supporting manufacturing operations. We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Requirements

  • Bachelor's degree in Life Sciences, Engineering, Business Administration or related technical field required
  • Minimum 10+ years biopharmaceutical manufacturing experience
  • Minimum 5+ years progressive leadership experience in GMP environment
  • Proven experience managing quality systems, production planning, or manufacturing support functions
  • Deep understanding of cGMP regulations (21 CFR Parts 210, 211, 600)
  • Experience with deviation management, technical writing, and batch record systems
  • Knowledge of manufacturing execution systems (MES) and ERP platforms (SAP preferred)
  • Understanding of buffer/solution manufacturing and component preparation processes
  • Strong leadership and people development skills
  • Excellent communication and cross-functional collaboration abilities
  • Strategic thinking with strong execution capabilities
  • Problem-solving and continuous improvement mindset
  • Ability to work in manufacturing environment with cleanroom gowning
  • Flexibility to respond to operational needs outside standard hours

Nice To Haves

  • Advanced degree (MS, MBA, or PhD) Life Sciences, Engineering, Business Administration or related technical field - Preferred
  • Experience with vaccine or biologics manufacturing
  • Six Sigma or Lean Manufacturing certification
  • iShift and SAP system experience

Responsibilities

  • Oversee manufacturing quality systems team responsible for deviation investigations, root cause analysis, and CAPA implementation
  • Direct technical writing activities including SOPs, batch records, work instructions, and logbook management
  • Ensure compliance with cGMP regulations and company quality standards
  • Support regulatory inspections and audit readiness activities
  • Lead production planning team including scheduler and iShift/SAP specialist
  • Oversee production scheduling, material planning, and manufacturing execution system operations
  • Ensure accurate system transactions and data integrity in iShift and SAP platforms
  • Coordinate with cross-functional teams to optimize production flow and resource utilization
  • Manage manufacturing support team responsible for buffer and solution preparation
  • Oversee component preparation, glassware cleaning, and material readiness activities
  • Ensure GMP compliance in all manufacturing support operations
  • Drive continuous improvement initiatives across support functions
  • Lead, develop, and mentor team managers and specialists across three functional areas
  • Establish and monitor key performance indicators for quality, efficiency, and compliance
  • Foster culture of safety, quality, and continuous improvement
  • Manage resource allocation and workforce planning across multiple teams

Benefits

  • Bring the miracles of science to life alongside a supportive, future-focused team.
  • Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
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