Senior Product Quality Manager (Peptide Technology)

About the Role

Responsible for the quality of assigned new product introduction programs to ensure business objectives are met regarding on-time deliverables of program development while assuring compliance with local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), and Drug Products produced by AbbVie plants or by third-party manufacturers, in Licensing relationships, or Co-Marketing relationships.

AbbVie Operations Quality Assurance is seeking a Product Quality Manager to lead quality deliverables for late-stage development and commercialization of Peptides, from registration through commercialization. This role works in a multi-functional team environment at our North Chicago, IL location.

Responsibilities

• Leads the development and implementation of global Product Quality Assurance strategy to support New Product Introduction (NPI) programs for the end-to-end commercial supply chain at AbbVie plants as well as contract manufacturing facilities.
• Drives implementation of the Product Transfer Process.
• Primary driver for product quality risk management and compliance aspects of product development.
• Acts as global quality lead to support regulatory submission by developing, reviewing, and approving relevant module 3 documents.
• Works with Regulatory Affairs and coordinates with GMP manufacturing sites to prepare submissions and provides responses to agency submission deficiencies/questions in a timely manner.
• Leads and manages pre-approval inspection readiness for the NPI programs.
• Ensures regulatory approvals are obtained with no delays to market entries.
• Leads the selection of external manufacturing partners from a Quality perspective for NPI programs.
• Leads the quality partner assessment and upskilling of partners to meet AbbVie Operations expectations.
• Partners with Quality Assurance audit team to qualify external manufacturing partners.
• Communicates and negotiates with external manufacturing partner quality organizations to maintain a consistent level of quality.
• Provides quality oversight to maintain partner qualification for development and commercialization.
• Supports the management of exception documents and Corrective and Preventive Actions. Coordinates input from technical groups to determine root cause and implement appropriate actions.
• Serves as global quality representative at the change review board to drive/support global change plans needed for NPI programs.
• Establishes and maintains relationships and open communication with cross-functional groups to clarify roles and responsibilities and provides guidance on quality concerns.
• Drives continuous improvement for NPI programs.

Requirements

• Bachelor’s Degree in a relevant Science field required.
• Minimum 8+ years of total combined experience.
• At least 3 years in Quality Assurance Operations Management; 5+ years in any of the following areas: Operations, Research and Development, Regulatory.
• Direct Manufacturing Plant experience in a pharmaceutical setting is preferred.
• Comprehensive understanding of pharmaceutical technologies, specifically peptide technology, is required.
• Experience in pharmaceutical development and commercialization is preferred.
• Strong quality assurance/control background is required.
• Experience with FDA and other regulatory agency interactions and inspections is required.
• Ability to interact well with diverse groups within the function and maintain strong working relationships with internal and external collaborators.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan for eligible employees.
• Eligibility to participate in long-term incentive programs.

Pay

The compensation range for this role is based on the job grade and may ultimately pay more or less than the posted range, depending on factors including geographic location. This range may be modified in the future.