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Manager – Packaging Operations and Third-Party Quality

Job Description
The Manager – Packaging Operations and Third-Party Quality is responsible for overseeing the disposition and release determination for all Alora distributed products manufactured by external third parties, as well as the quality review and approval of related quality documentation and labeling for Alora distributed products and the coordination of global change controls.  The position is also responsible for oversight of the quality functions supporting internal packaging operations.

Key Responsibilities/Essential Functions

• Oversee and maintain a program for the critical review of batch record documentation for products manufactured by external third parties.
• Oversee the review and approval of related quality documentation generated at third parties including, but not limited to deviations, out-of-specification investigations, change controls, process validation protocols/reports, and master batch records. Ensure appropriate action is taken in response to any product related investigations.
• Assist with performance of high-risk or global risk assessment impacting Alora manufactured and/or distributed products.
• Oversee a program for the review of annual product reviews generated by third party vendors; the collection, review, and reporting of product data needed to supplement third-party vendor annual product reviews; and the monitoring of due dates for submission of annual product reviews and perform follow-up activities.
• Manage execution of a corporate USP change management system that reviews the changes to USP and implements associated corporate change controls related to those changes.
• Assist with the creation and implementation of new corporate policies.
• Monitor changes to regulatory policies and assist in the implementation of these policies.
• Perform the Quality review and approval of labeling for all Alora distributed products.
• Oversee the creation and management of global change controls impacting multiple corporate entities.
• Provide leadership and oversight for quality inspectors and leads responsible for quality oversight of critical packaging processes at internal packaging facilities.
• Oversee Label Control processes, including issuance, reconciliation, and appropriate documentation controls.
• Provide oversight and guidance for investigations of deviations related to products, processes, and utilities, including evaluation of corrective actions and process improvements to prevent recurrence.
• Oversee Quality Hold activities and material or product rejection processes to ensure appropriate control, documentation, disposition, and escalation.
• Oversee temperature and humidity monitoring programs, including excursion assessment, documentation, follow-up, and trending.
• Assist with the development and maintenance of procedures that define the cGMP activities within the areas of responsibility.
• Escalate issues to Senior Management as appropriate.
• Implement and oversee the tracking of metrics that effectively measure performance and allow for the identification of adverse trends within the areas of responsibility.
• Serve as the Quality representative for change controls related to the areas of responsibility as assigned.
• Develop and lead a strong quality team providing effective leadership, support, training, guidance, and mentorship.
• Champion quality improvement processes within the areas of responsibility to ensure adherence to cGMPs and foster continuous improvement.
• Review industry trends and changes to regulations and collaborate with other corporate teams to implement best practices and global policies.
• Support a culture of quality and continuous improvement throughout the organization.
• Perform other duties as assigned by Management.

Basic Qualifications
 

• Bachelor’s degree required; Bachelor’s or advanced degree in a scientific or technical field, preferred.  

• Minimum of 3 years of quality experience in FDA regulated industries (pharmaceutical or biotech industries, preferred).
• A minimum of 1 year of progressive management responsibility, preferred.

• Thorough knowledge of FDA Quality System requirements.

Other Requirements
 

• Proficient with Microsoft office applications.
• Excellent verbal and written communication skills with the ability to interact across functions, departments, and seniority levels.
• Ability to explain problems, solutions and make recommendations, and the ability to handle various urgent requests in a professional manner.
• Ability to analyze, problem-solve, and perform detail-oriented work with a high degree of accuracy.
• Works under minimal supervision; requires a high level of independence.
• Effective time management and interpersonal skills.
• Willingness and ability to travel both domestically and internationally (~ 5% - 10% of the time), requiring a valid passport. Ability to obtain a VISA.