Supplier Quality Associate

Description

This position supports the Internal Audit Program, External Supplier Audit Program, and the Supplier Quality Management System. The role is responsible for assessing and ensuring that external suppliers, contract service providers, and internal operations comply with Alora standards and applicable U.S. and international GxP regulatory requirements governing the manufacture, testing, and packaging of commercial drug products.

Essential Responsibilities:

Audit Execution & Compliance Oversight

• Plan, perform, and document GxP compliance audits to evaluate adherence to U.S. and international regulatory requirements and Alora Quality Standards.
• Conduct external GxP audits of excipient, API, and component suppliers; contract laboratories; contract manufacturers; contract packagers; and CROs (routine and risk-based).
• Conduct internal GxP audits of Alora sites and functions.
• Provide guidance and support to sites in preparation for regulatory inspections (e.g., PAI, general GMP) and assist with post-inspection follow-up activities.

Audit Reporting & Communication

• Communicate audit observations, nonconformances, and compliance risks to relevant stakeholders in a clear and timely manner.
• Prepare comprehensive audit reports that accurately reflect audit findings, regulatory impact, and overall compliance status.
• Review and manage audit reports issued by third-party auditing firms and ensure appropriate follow-up and closure of identified issues.

Supplier Quality & Regulatory Compliance

• Assist in the development, review, and maintenance of Quality Agreements with suppliers and service providers.
• Maintain current knowledge of evolving global regulatory requirements related to drug product manufacturing, testing, and supply chain controls.
• Interpret and apply FDA regulations, international guidelines (e.g., ICH, EMA), internal SOPs, and corporate policies to ensure ongoing regulatory compliance.
• Perform additional duties as assigned to support internal auditing, supplier qualification, and supplier management activities.

Core Competencies:

• Ability to work independently, interpret and assess technical documents, communicate and interact effectively across multiple organizational levels
• Strong written communication skills to organize information into a clear, concise written form which fosters adherence to current GxP compliance
• Ability to adapt to organization priority changes and work effectively with minimal supervision with a sense of urgency
• Willingness and ability to travel (~20% of the time)
• A high level of proficiency in Microsoft Office applications required

Minimum Qualifications:

• Bachelor’s degree in Life or Physical Science or related science from an accredited college or university
• Knowledge of pharmaceutical production and application of cGxP regulations in manufacturing of commercial products
• Ability to interpret guidelines and regulations as applied to manufacturing of multiple products and product attributes
• 2 years of experience as a GMP auditor; CQA and/or CQE Certification is a plus

Preferred Experience

• 1 year of experience in pharmaceutical auditing
• Knowledge of manufacturing and packaging equipment and equipment used to verify product quality
• Previous experience assisting with regulatory agencies inspections

PHYSICAL DEMANDS

The physical demands described are representative of those required to perform the essential duties of the position. Reasonable accommodations may be made to enable individuals with disabilities to perform th e es essential functions.

While performing the essential duties of this job the employee is frequently required to stand, walk, and reach with hands and arms. The employee is regularly required to sit, use the hands and fingers to type via the u se of the PC (Personal Computer). There are no lifting requirements; however, travel is expected so the general transport of a laptop and personal luggage will take place. No Personal Protective equipment required, unless entering production areas.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.