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Job Details

ID #41153831
State Massachusetts
City Lexington
Job type Contract
Salary USD competitive competitive
Source Real Staffing
Showed 2022-05-19
Date 2022-05-19
Deadline 2022-07-18
Category Et cetera
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Quality Manager

Massachusetts, Lexington, 02420 Lexington USA

Vacancy expired!

Job Summary The successful candidate will be experienced in performing and managing expected Quality Management System related tasks. The candidate will have experience managing people, systems, and processes and communicating across multiple levels within a company. The position will serve as a key point of contact for company's QMS while performing multiple tasks, including but not limited to, maintaining and co-authoring compliant GMP and non-GMP documentation in support of various Quality Systems including the purchasing controls, lot release controls, audit management, supplier management, nonconformances, root cause analysis, and investigations. The Quality Manager is a Subject Matter Expert (SME) in multiple areas of Quality, a trainer for such processes, and will supervise and guide junior members of the organization.

Job Description
  • Applicable Title(s): Quality Manager
  • Applicable Division or Department: Quality Organization
  • Typically reports to: Head of Quality Assurance, Quality Director

Essential Functions

  • Review and approve records through the Electronic Document Management System.

  • Support Implementation and management of various QMS elements including
    • A purchasing controls program by (but not limited to) developing and implementing SOPs for purchasing controls, materials management, supplier management, and quality technical agreements. In that, establish an approved supplier list, approved sourced materials list, and QTA template. A internal and external audit program. Establish an annual schedule for internal and external audits. Ensure audit schedule is executed as planned and conduct audits as appropriate. Follow-up on audit observations until adequate closure. Deviations, CAPAs, Change Control, and the maintenance of the lot genealogy system.

  • Schedule, manage and perform audits.
  • Review of master batch records, executed batch records, and other quality records.
  • Perform trending and analysis as required and provide metrics to quality management as requested in preparation for Management Review.
  • Support and maintain a work environment in accordance with company's core values (Learn, Create, Safety, Patients First, Integrity, Courage, and Team Work) while fostering open communication, collaboration, integration, and teamwork.
  • Stay abreast of changes in applicable regulations, directives and guidelines and determine its impact on company programs.
  • Provide mentorship, guidance, and training to Quality and other GXP compliant personnel.
  • Provide flexible and novel approaches to Quality processes to start-up the company's internal programs.
  • Complete other duties and tasks as required.
  • This role will follow a hybrid model (virtual/on-site) until new facility is operational.

    • Position Qualifications
    • Education Level: BA/BS degree in a business and/or life sciences related field or equivalent experience.
    • Years of experience in the subject area: 5 to 8 years combined Quality organization experience.
    • Proficient knowledge in in cGMP environment in pharmaceuticals and biologics. Cell and gene therapy is a plus.
    • Experience with GMP/Google Cloud Platform/ICH standards and regulatory guidance documents.
    • Experience in start-up or consulting environment is a plus.
    • Licenses required: N/A

    Preferred Experience
    • Holding any of the following roles could help prepare the individual for the responsibilities and duties of the job description:
      • Quality Specialist.
      • Lead Auditor.
      • Quality Systems Specialist.
      • QA Supervisor.
      • Quality Engineer.
      • Quality Manager.
      • 5+ years of experience in the pharmaceutical or biotechnology industry. Cell and gene therapy is a plus.
      • Experience supporting and performing internal and external audits.
      • Proficient with MS-Office tools (Word, Excel, PowerPoint, etc.).
      • Experience with document management systems or quality management systems is required.
      • Ability to work independently and in team environments.
      • Must be flexible, organized, detail-oriented, and able to handle multiple priorities in a fast-paced environment.
      • Excellent oral/written communication, problem solving/issue resolution, and prioritization skills.

    EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

    To find out more about Real please visit

    Vacancy expired!

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