Sr. Principal Associate - Quality AQR

Role Summary

The Sr. Principal Associate QA Authorized Quality Representative - AQR is responsible for final disposition of Finished drug products. This role provides guidance to the site in managing key technical, quality, and compliance issues related to the batch release during the product life cycle and annual review process. The AQRs serve as a technical leader within Quality to ensure proper adherence to Global and Local Quality requirements and ensure that there are adequate quality systems in place related to the Batch Disposition process to ensure product released to the market meets applicable GMP standards.

Responsibilities

• Quality Systems Management
• Own or serve as a subject matter expert of change controls, deviations, process validation activities, or other quality items related to the batch release and annual product review processes for vials, devices, and dry products.
• Perform final batch disposition of semi-finished and/or finished drug product batches for Indianapolis Device Assembly and Packaging products, including commercial, clinical, and non-commercial materials to ensure high quality medicine (GMP Compliance) is released to market in a timely manner.
• Accountable to lead and serve as a liaison for the evaluation and completion of shipment under quarantine request.
• Qualifies quality representatives in the batch release process for vials, sub-assembly, final assembly, and dry packaging.
• Contribute to the execution of APRs
• Provide guidance in operational areas to ensure robust Quality Systems and GMP compliance.
• Participate in self-led inspections and/or provide support during internal / external regulatory inspections.
• Effectively review / approve GMP documents to ensure quality attributes are met (i.e., Non-conformances, procedures, protocols, specifications, and change controls).
• Participate in project or process improvement initiatives to improve productivity within the Batch Disposition work center and/or other areas designated in the site.
• Ensure regular presence in operational areas to monitor GMP programs, quality systems, and strengthen quality culture.
• Can be identified as power user of systems such as SAP and EWM
• Cross functional/Network/Coaching
• Work within cross-functional teams in a positive fashion to implement quality objectives and deliver on business plan and site objectives.
• Interact with regulators, or other outside stakeholders on quality / compliance issues or in support of internal and external agency audits.
• Provide technical leadership to key quality matters related to major and/or significant deviations and investigations.
• Coach and mentor quality operations and other functions supporting in topics related to batch disposition review, annual product holistic review, quality and GMP compliance, operational excellence, technical documentation, issue resolution, and process monitoring.

Qualifications

• Required: Previous experience directly supporting pharmaceutical manufacturing or quality, with experience in pharmaceutical products
• Required: Ability to make technical decisions, provide guidance to the site and lead others.
• Required: Proficiency with applicable computer systems.
• Required: Authorized to work in the United States on a full-time basis. No visa sponsorship is available for this role.
• Preferred: 5+ years’ experience directly supporting pharmaceutical manufacturing or quality, with experience in pharmaceutical products.
• Preferred: Proficiency with SAP, MES (PMX), Darwin, and TrackWise, Veeva
• Preferred: Technical Writing and Communication Skills
• Preferred: Demonstrated strong oral and written communication skills.
• Preferred: Demonstrated interpersonal skills and the ability to work as a team.
• Preferred: Root cause analysis / troubleshooting skills.
• Preferred: Demonstrated attention to detail and ability to maintain quality systems.

Skills

• Quality systems management and GMP compliance
• Technical leadership and cross-functional coaching
• Process improvement and project management
• Regulatory inspection support and coordination
• Technical writing and clear communication
• Root cause analysis and troubleshooting
• System proficiency: SAP, EWM, TrackWise, MES (PMX), Darwin, Veeva

Education

• Bachelor Degree in chemistry, science, engineering and pharmacy