JOB TITLE : Quality Manager (US/Canada)

ROLE SUMMARY

What are the key objectives and expectations from this role?

• The Quality Manager (US/Canada) – is one of the key roles to 1) establish 2) assure and 3) manage quality systems and processes both (A) Internally and (B) Externally.

• The key objective of this role is to ensure the quality systems and processes of internal and 3rd Party Suppliers across the tiered category network meet the regulatory and business needs.

• The role will be US/Canada focused supporting the local subsidiary, with an expectation to support Global Quality activities as required.

Reports to : Senior Quality Manager

Number of Direct Reports : 0

Core Relationships

• Internal – U.S subsidiary & Canadian branch. Operations, R&D, packaging & global quality.

• External – 3rd Party Service providers including manufacturing, warehousing, and distribution partners.

Geographic Scope : US / Canada

Travel Required : Yes, up to 15%

ACCOUNTABILITIES

Manage Regulatory Quality Compliance

• Manage Quality Management 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 programs.

Ensure Quality in Project and Process Design

• Manage Risk: Mange Risk through creation and review of 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.

Manage in-Market Quality

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

• Manage Product Review Team. Manage local communication, trending and review of Consumer complaints and Adverse Event.

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

• Manage Product Recall: Support recalls as required. Manage Mock recalls.

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 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

Experience Required

• 3 Years Professional Quality Experience within industries such as Dietary Supplements, Natural Health Product or Pharmaceutical.

• Experience of developing and managing Quality Systems (e.g. Procedure creation Document Management, Change Control and Consumer Complaints)

• Competent auditor with experience of evaluating and assessing Suppliers, Contract Manufacturers, warehousing and distribution partners.

• Experience in Managing 3rd Party Service providers across a broad range of technical processes such as material suppliers (packaging, ingredients, etc.) contract manufacturers, warehouse and distribution partners.

• Experience in managing and delivering training programs.

Technical / Functional / Leadership Skills Required

• Solid understanding of Good Manufacturing Practice for Natural Health Products and/or Dietary Supplements

• Demonstrable interpersonal and communication skills,

• Track-record of managing senior stakeholders across the commercial and operational business.

• Use of Risk Management tools such as FMEA or HACCP

• Excellent level of report writing

• Experience with implementing continuous improvement projects.

• Experience working within weekly and monthly control cycles.

• Ability to work autonomously.

Education / Qualifications / Certifications Required

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

• Lead Auditor Certification (Nice to have)