VSM Laboratory Manager (Biologics Industry) at Fortive

Irvine, California, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Jan, 26

Salary

0.0

Posted On

15 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Laboratory Operations Oversight, Process Improvement, Quality Assurance, Regulatory Compliance, Leadership, Mentorship, Training, Collaboration, Continuous Improvement, Non-Conformance Management, Validation, Quality Control, Communication, Resource Allocation, Workflow Management, Safety Protocols

Industry

electrical;Appliances;and Electronics Manufacturing

Description

Laboratory Operations Oversight: Manage and coordinate all aspects of laboratory operations, including scheduling, resource allocation, and workflow management. Ensure adherence to standard operating procedures (SOPs), safety protocols, and regulatory requirements (e.g., FDA, GMP). Apply FBS principles to identify opportunities for process improvement and waste reduction in laboratory workflows. Develop and maintain procedures for investigating non-conformances, identifying root causes, and implementing corrective/preventive actions (CAPAs). Ensure effective implementation of CAPA plans to address non-conformances and prevent recurrence. Collaborate with validation teams and stakeholders to execute protocols and document validation activities. Conduct quality assurance activities, including internal audits, inspections, and documentation reviews to maintain regulatory compliance. Implement quality control measures to ensure accurate and timely completion of testing and reporting. Collaborate with R&D, manufacturing, and regulatory affairs teams to support product development and commercialization efforts. Communicate effectively with senior management, presenting laboratory performance metrics, project updates, and improvement recommendations. Provide leadership and mentorship to laboratory staff, fostering a culture of teamwork, continuous learning, and professional development. Conduct training sessions on FBS methodologies, quality assurance practices, and regulatory compliance for laboratory personnel. Bachelor's degree in Biology, Biochemistry, Chemistry, Engineering, or related field; advanced degree (e.g., MS, PhD) preferred. Minimum of 5 years of experience in laboratory management within the biologics or pharmaceutical industry. Strong proficiency in continuous improvement methodologies with certification (e.g., Green Belt, Black Belt) and practical application experience. Expertise in managing non-conformance processes, equipment/process validations, and equipment qualifications. Thorough knowledge of regulatory requirements (e.g., FDA, GMP) governing biologics laboratory operations. Experience with quality management systems (QMS) implementation and internal auditing. Excellent leadership, organizational, and communication skills with the ability to lead teams and collaborate effectively across departments.

Responsibilities

Manage and coordinate all aspects of laboratory operations, ensuring adherence to SOPs and regulatory requirements. Collaborate with various teams to support product development and maintain quality assurance activities.