QA Manager - OTC​/Consumer Health

Alliance is looking for a Quality Manager US to be based from our Cary, North Carolina office 2 days a week. Alliance is a consumer healthcare organisation going through an exciting period of growth, our OTC key products in the US include Amberen and Scar Away

This is a Quality Management role works closely with our contract manufacturing organisations in the US and internal key stakeholders (commercial, supply chain, legal). As the Quality Manager you will deliver US quality business objectives as outlined below and ensure that the Alliance business operates in compliance with our QMS and all quality requirements. You will also implement and manage all Quality Assurance activities within the US to ensure compliance with the applicable Good Manufacturing Practices

• Bachelor’s degree in biological, chemical or physical sciences or related disciplines
• Extensive Quality Assurance experience in consumer healthcare - dietary supplements and OTC products.
• Previous experience working with a CDMO
• Qualified ISO 13485 auditor would be highly desirable
• Proven track record of successful interaction with FDA, including FDA inspections.
• Advanced understand of GMPs and other relevant codes of practice.
• Ability to contribute to the design, develop, document, implement and improve
• Previous experience working with a CMO would be highly beneficial.
• Strong and effective communication skills

• Lead all regional Quality and Technical activities, directly executing or delegating as needed to ensure compliance and performance.
• Manage stakeholders (both internal and external) to deliver the business requirements.
• Effectively secure, train and manage resources to deliver the regional Quality and compliance strategies and business plans, including personnel and financial management.
• Management of budgets associated with Quality and Technical activities within the region.
• Drive best practices, process improvements with Quality and instilling a culture of Quality within the organization.
• Contribute, as required, to the design of Quality and compliance strategies for the region, under the direction of Global Quality senior management.
• Implementation of Quality and compliance strategies within the region, aligned with business needs and ensuring the most favourable outcomes for the business.

• Management of regional regulatory compliance (GMP & GDP as applicable), including the implementation, maintenance and operation of policies, processes and systems as required to comply with current legislation, regulation and codes of practice.
• Manage regional FDA authority relationships during site inspections, including correspondence and remediation plans.
• Minimize business risk by monitoring any changes to GMP requirements, providing advice, guidance and direction on compliance matters to the regional management team, helping regional business functions, as required, to maintain a state of GMP compliance and inspection readiness.

• Implement and effectively operate the QMS compliant with company policies and regional legislation, including periodic performance reporting.
• Develop, implement and maintain fit for purpose Quality Management System tools as applicable (i.e., eQMS) to support the operations of the North America region and associated global affiliates.
• Implement and effectively operate one or more self-inspection / audit programs to verify compliance with applicable company policies, procedures, regulation and legislation.

• Quality management of the regional supply network, including the selection, qualification and compliance management of consultants, suppliers and distributors, and drafting of Quality Technical Agreements and Statements of Work. Secure continuity of supply by planning for and mitigating Quality and Technical risks.
• Management of QA and Technical activities carried out on behalf of Alliance by CMOs.

• Deliver regional technical projects to time, cost and quality by proactively working with CMOs, and identify and address any issues that may arise. Secure on-time/on-budget launches by planning for and mitigating technical risks.

• Practice Continuing Professional Development (CPD) in order to keep abreast of current good industry practices and incorporate into QMS where appropriate.
• Support continued business growth through the performance of due diligence and integration management of corporate or asset acquisitions, with respect to Quality activities.