Quality Manager
- Category: Et cetera
- Deadline: 01st August 20222022-08-01T00:00:00-0700
- North Carolina
Vacancy expired!
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.
- Manage Risk: Mange Risk through creation and review of HACCP risk assessment for locally led activities
- 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
- 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
- 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.
- 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 working within weekly and monthly control cycles.
- 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
- Bachelor of Science degree applied Science, e.g Chemistry, Biology or Food Science