Senior Quality Manager

california
Permanent
$140k - 160k per year
QARA & Validation

My client who is an industry leading life sciences company based in Valencia, CA currently has a rare vacancy for an experienced Senior Quality Manager to join their team.

In this role, the Sr Manager Quality for the site of Valencia will provide leadership support to the Laboratory Director, Site Manager, and supervisors on all quality related matters.  S/he will develop and implement training and education programs, to educate workers and management on quality processes, standards, and results.  S/he will facilitate all review meetings with pertinent business leaders both at the site and within higher levels of management.  A strong candidate for this position will be able to maintain good rapport and communication with leadership, team members and customers while ensuring solid execution of all quality programs.

Responsibilities:

  • Maintains laboratory license as required by CLIA, CAP and local regulations.
  • Maintains the quality management system.
  • Performs Annual Effectiveness Review.
  • Ensures training and competency documentation is up to date by working with Department Leaders.
  • Acts as liaison between Regulatory Inspectors and Department Leaders during the preparation for, and performance of Regulatory Inspections by outside agencies.
  • Oversees Incident Management reporting.
  • Acts as Lab’s administrator for CAP website and proficiency testing programs.
  • Works with department managers to ensure proficiency testing is completed and submitted.
  • Reviews external audit reports and prepares responses.
  •  Administrates Medialab Document Control System and ensure SOPs, Trainings and Policies are current versions and assigned appropriately.  Notify Department leaders of employee signoffs not completed within deadlines.
  • Administrate Medialab SOP, Personnel, and Incident Management modules.
  • Review all SOPs, validations, and incident reports to ensure they meet Quality standards and adhere to company guidelines.
  • Demonstrates task leadership/ Project management skills with a track record of timely achievement of goals.
  • Ensures quality assurance and control of laboratory performance through internal and external audits.
  • Works with Department leaders to ensure internal audits are completed.
  • Project Management: Plan, initiate and management quality improvement projects.
  • Ensure safety, security, and the environment in all aspect of the daily activities, and any potential safety hazards are addressed and corrected immediately.
  • Understand ergonomic relationship between people, equipment and working environment.
  • Other duties as assigned.

Basic Qualifications:

  • Bachelor of Science degree in a heavy science and/or clinical laboratory science or equivalent. 
  • 4+ years of clinical laboratory experience in a role leading quality activities.  
  • Extensive knowledge of CLIA, CAP, California quality system principles, concepts, systems, industry practices, and standards to include experience with implementation of new systems.
  • Minimum of 2-3 years managerial experience in a CLIA lab environment and strong leadership skills to foster a high performance, teamwork-oriented laboratory environment.

Preferred Qualifications:

  • Previous experience of working in quality in clinical molecular biology or infectious disease testing labs.
  • Strong interpersonal skills and high communication proficiency both verbal and written, in technical and non-technical domains. The desire and ability to communicate and mentor is a key component of the role.
  • Work collaboratively and in partnership with laboratory operations staff.
  • Proven track record of delivering continual positive process improvement in systems and process.
  • A good balance of negotiating and influencing skills.
  • Excellent presentation skills.
  • Good, accurate computer skills.
  • Be detail oriented, organized.
  • Able to work effectively and able to deliver on tight datelines.
  • Familiarity with operation of laboratory instruments and applicable computer software.
  • Knowledge of FDA quality system regulations.

Working Environment:

  • Clinical and research lab environment; exposure to blood borne pathogens; must wear personal protective equipment including lab coat, gloves and completely closed footwear.
  • Employee may be requested to work shifts other than daylight depending on the needs of the laboratory.
  • Weekend rotation may be required.
  • Travel is not required.

Physical Requirements:

  • While performing the duties of this job, the employee is regularly required to sit, stand, use a keyboard, type, and occasionally stand and move to other parts of the facility.
  • Must have manual dexterity to use computer and other office equipment.
  • Reach above/below the shoulder, bend at the knees and waist.
  • Able to lift boxes up to 25 pounds.

Please contact Johnny Thomson on (213) 320 – 1824 to learn more or send your CV through to j.thomson@x4lifesciences.com

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