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QMS Lead

Employer
Resilience
Location
Alachua, FL
Start date
Feb 22, 2024

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Job Details

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary:

The QMS Lead role is a site position located in Alachua, FL reporting to the Head of QMS & Compliance. The primary responsibility of this role is to support the Site in all three areas of Quality Management Systems including but not limited to Auditing, Document Control and Training. The role will perform day to day tasks in all three areas as well as lead and support specific projects related to implementing quality improvements, monitor Quality Management Systems data, create, review & improve GxP documents. The QMS Lead's primary function is to support the Quality Management System in all areas to ensure the Site is in a state of compliance with Site and Network Procedures, Standards, and Regulations and utilize Site Metrics to support Quality Improvement Plans and execute deliverables.

Job Responsibilities:

  • Support Audit program by assisting in the assessment of the organization to ensure compliance with applicable standards, regulations, and guidance.
  • Coordinate and Complete action plans and follow-up with Site personnel to assure prompt and adequate completion of agreed upon actions from projects or actions related to the Quality Management System.
  • Review, evaluate and assess documentation to ensure compliance to cGMP, industry standards and other applicable regulations.
  • Cross train in departmental duties to assist in meeting the resource needs of the department as assigned including Training, Document Control, Auditing and Quality Operations.
  • Schedule, plan, conduct and lead internal meetings such as CAPA Effectiveness Evaluation.
  • Evaluate data in the QMS to support the development of Trend Reports and support the creation of action plans to execute and coordinate with other GxP departments to perform.
  • Monitor and continuously improve the Quality Systems. Perform Gemba Walks to support Inspection Readiness.
  • Act as lead trainer and Subject Matter Expert for QMS systems in training end users in all Quality Management Systems and supporting functions.
  • Maintain and author documents (SOPs, WIs, Forms, Records) associated with all functions of Quality Management Systems to include writing, reviewing, training, and revising as needed.
  • Assess, evaluate, train, and qualify other system users in the eLMS and eDMS within the organization.
  • Work directly with GxP departments on creating lessons learned opportunities for maintaining a high-Quality Culture Standard.
  • Able to lead tasks delegated by Head of QMS & Compliance.
  • Position may require travel both domestically and internationally up to 10% of the time.

All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

Minimum Qualifications:

  • Knowledge of biologics global regulatory requirements (i.e.FDA, EMA, PMDA, Health Canada, etc.)
  • Demonstrated experience in the understanding of working in eDMS and eLMS
  • Demonstrated experience in leading projects with successful outcomes.
  • Excellent communication, organization, and customer service skills
  • Demonstrated ability to change priorities and manage multiple tasks with short deadlines.
  • Ability to work at a fast pace and build positive working relationships with GxP department personnel.


Preferred Qualifications:

  • Bachelor’s degree or higher in a science or technical field
  • Significant experience in biologics or pharmaceutical QA with strong QA auditing experience
  • ASQ Certified Quality Auditor or similar
  • Lean Six Sigma experience.


This position may also include the following conditions:

Physical Requirements:

This job requires the employee to perform the following physical activities:

  • Climbing
  • Balancing
  • Fingering
  • Stooping
  • Kneeling
  • Repetitive motion
  • Crouching
  • Feeling
  • Reaching
  • Standing
  • Grasping
  • Walking
  • Pushing
  • Hearing
  • Pulling
  • Lifting
  • Talking

This job requires the employee to work in the following conditions:

  • Temperature changes
  • Activities occur inside and outside.

This job requires exposure to the following:

  • Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
  • Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 2, including for emergency response.
  • Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.

This job requires the employee to perform the following type of physical work:

  • Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.

This job requires the following visual acuity requirements:

  • Preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
  • Determines the accuracy, neatness, and thoroughness of the work assigned (i.e., custodial, food services, general laborer, etc.) or to make general observations of facilities or structures (i.e., security guard, inspection, etc.).

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $95,000.00 - $132,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Company

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience 

Company info
Website
Location
9310 Athena Circles
La Jolla
CA
92037
United States

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