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Senior Manager, Quality Laboratory Value Stream

Danaher CorporationPensacola, FL
Onsite

About The Position

As the Senior Manager, Quality Laboratory Value Stream, you will collaborate closely with cross-functional leaders and associates to ensure effective identification, execution, monitoring, and continuous improvement of Quality Laboratory and Batch Review operations, aligned with regulatory requirements, organizational objectives, and customer expectations. This position reports to the Senior Manager, Site Quality and leads the Quality Control organization at the Pensacola, Florida site. This is an on-site role. At Cytiva, our vision is to advance future therapeutics from discovery to delivery.

Requirements

  • Hold a Bachelor’s degree in Science or a related field, or equivalent experience (10+ years) within a regulated manufacturing or laboratory environment.
  • Bring 7+ years of experience in Laboratory Operations, Quality, or Manufacturing within Life Sciences, Biotechnology, Medical Devices, Biopharma, or other FDA/EPA-regulated industries.
  • Have 5+ years of people leadership experience, including direct management of laboratory or manufacturing teams.
  • Demonstrate strong knowledge of ISO 9001, ISO 13485, FDA regulations, cGMPs CFR requirements, and core quality processes such as validation, CAPA, audits, complaint handling, and risk management.
  • Apply quality statistics, Lean and Six Sigma tools, SPC, Gage R&R, and root cause analysis to drive data-based decisions and optimize laboratory resources.
  • Proven ability to coach and mentor leaders, manage performance, plan succession, and communicate effectively across all organizational levels.
  • Strong organizational and time-management skills with the ability to balance strategic priorities, assess opportunity cost, and drive disciplined execution with a passion for making a measurable impact.

Nice To Haves

  • Experience with ISO 14644 and/or ISO 17025 is preferred.
  • Previous Experience In Analytical chemistry and/or microbiology in an ISO 17025-accredited laboratory environment.
  • Contamination control, sterilization, sanitation, or E-beam processes, including ISO 14644 cleanroom operations.
  • Enterprise systems such as SAP, Oracle, Veeva, or Magic, supporting laboratory or quality operations.

Responsibilities

  • Lead the Pensacola Quality Control organization, ensuring raw materials, intermediates, and finished goods meet clearly defined, compliant acceptance and rejection criteria while delivering on safety, quality, cost, and on-time performance expectations.
  • Own and strengthen the effective application of the Cytiva QMS, ensuring procedures, records, and digital systems enable compliant operations, audit readiness, and continuous improvement through CAPA, risk-based thinking, and Danaher Business System (DBS) methodologies.
  • Partner with site and global leadership to drive process improvements, lead change management activities, advocate for laboratory-specific needs, and ensure quality considerations are fully integrated into product development, technology transfer, and operational changes.
  • Build, lead, and sustain a high-performing laboratory organization by fostering a culture of engagement, accountability, psychological and physical safety, capability development, and continuous improvement.
  • Optimize laboratory flow and capacity by managing staffing and shift coverage, improving lead times, ensuring equipment qualification and maintenance, establishing back-ups for critical instrumentation and consumables, and owning laboratory capital expenditure planning and budget management.
  • Lead laboratory investigations, define and monitor key performance indicators, assess and mitigate operational and compliance risks, and represent the Pensacola laboratory in global best-practice forums, ensuring learnings are captured and applied to strengthen future design and reliability outcomes.

Benefits

  • paid time off
  • medical/dental/vision insurance
  • 401(k)
  • bonus/incentive pay

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