Quality Manager

Quality Manager

02 Jun 2022
North Carolina, Winston-salem, 27101 Winston-salem USA

Quality Manager

ACCOUNTABILITIES



Manage Regulatory Quality Compliance

  • Manage Quality Management/ Food Safety System: Manage local QMS documentation following global standards and polices

  • Management of Change: Management of locally led changes e.g. Packaging and Distribution

  • Support External Quality Audits: Provide quality support in audits performed by regulatory bodies and external certification bodies

  • Monitor Regulatory Requirements: Monitor changes to local regulatory quality requirements and manage updates to the local quality documentation. Feedback to global quality on changes to regulatory quality requirements.

  • Manage Deviations: Manage deviations to local procedures

  • Ensure Appropriate Qualification, Education and Experience: Implement and maintain local skill matrixes and training programmes.


Ensure Quality in Project and Process Design


  • Manage Risk: Mange Risk through creation and review of HACCP risk assessment for locally led activities


Contract Service Provider Quality Management

  • Support Selection of 3rd Party Service Providers: Support cross functional short list of 3rd Party Service providers by defining key quality requirements and gathering key information from internal or external providers.

  • Qualify Quality in 3rd Party Service Providers: Perform quality audits of 3rd Party service providers . Manage CAPA plans and provide feedback to key stakeholders. Ensure quality agreements are in place.

  • Monitor Quality in 3rd Party Service Providers: Develop and monitor quality KPIs and feedback to key stakeholders.

  • Batch Release: Perform batch release within the distribution chain



  • Manage in-Market Quality

    • Review and Investigate Consumer Complaint and Adverse Events: Support consumer complaint and adverse event investigations.

    • Provide data to Global Quality Team: Provide KPI (inc. Complaints and AE) to Global team for trend analysis

    • Manage Product Recall: Support mock recalls as required








    Job Description



    Support Global Quality Activities (As required)

  • Maintain Global QMS documentation: Create and update global QMS documentation

  • Support Globally Led Changes: Provide support to changes led by the global team

  • Support External Regulatory Audits: Provide quality support in audits performed by regulatory bodies and external certification bodies

  • Support Management of Deviations to Global Procedures: Provide support to deviations to global procedures

  • Support New Product Development: Provide support in completion of key quality activities e.g Quality control plans and through attendance of production trials.

  • Manage Risk: Manage Risk through creation and review of HACCP risk assessment for globally led activities

  • Requalify global service providers: Perform requalification quality audits of Global 3rd Party service providers.


  • Manage CAPA plans and provide feedback to key stakeholders.

    Batch release: Perform batch release of the contract manufacturer


    EXPERIENCE, SKILLS, KNOWLEDGE

    ESSENTIAL



    Experience Required

    • 3+ Years Professional Quality Experience within industries such as Dietary Supplements, Pharmaceutical or Food.

    • Experience of Managing Quality Systems (e.g Document Management, Change Control and Consumer Complaints)

    • Competent auditor with experience of evaluating and assessing Suppliers, Contract Manufacturers and 3rd Party Laboratories


    Experience in Managing 3rd Party Service providers across a broad range of technical processes such as material suppliers (packaging, ingredients, etc.) and laboratories


    • Experience working within weekly and monthly control cycles.




    Technical / Functional / Leadership Skills Required

  • Solid understanding of required standards for Food and/or Dietary Supplements (21CFR111), HACCP.

  • Demonstrable interpersonal and communication skills, credible track-record of managing senior stakeholders across the commercial and operational business including suppliers.
    Experience of Lean tools e.g., Lean 6 sigma, 5S and VSM.
  • Excellent level of report writing and technical / conversational English

  • Experience with implementing continuous improvement projects.

  • Ability to work autonomously



    Education / Qualifications / Certifications Required

  • Bachelor of Science degree applied Science, e.g Chemistry, Biology or Food Science









  • 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.


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