Senior Product Quality Manager (Peptide Technology)

Product Quality Manager

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. We are seeking a highly motivated candidate with a proven track record of accomplishment in the field of peptide manufacturing development, to work in a multi-functional team environment at our North Chicago, IL location.

Responsibilities include:

• Leading 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 both at AbbVie plants as well as contract manufacturing facilities.
• Acting as global quality lead to support regulatory submission by developing, reviewing and approving relevant module 3 documents. Working with Regulatory Affairs and coordinating with GMP manufacturing sites to prepare submissions and providing responses to agency submission deficiencies/questions in a timely manner.
• Leading the selection of external manufacturing partners from Quality for NPI programs. Leading the quality partner assessment and upskilling of the partners to meet AbbVie Operations' expectation. Partnering with Quality Assurance audit team to qualify external manufacturing partners.
• Communicating and negotiating with external manufacturing partner quality organization to maintain a consistent level of quality. Providing quality oversight to maintain partner qualification for development and commercialization.
• Supporting the management of exception documents and Corrective and Preventive Actions. Coordinating input from technical groups to determine root cause and implement appropriate actions. Serving as global quality representative at the change review board to drive/support global change plans needed for NPI programs.
• Establishing and maintaining relationships and open communication with cross-functional groups to maintain roles and responsibilities and providing guidance on quality concerns. Driving continuous improvement for NPI programs.

Qualifications include:

• Bachelor's Degree in relevant Science field required. Total combined years of experience. Minimum 8+ years. 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.
• Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators.

Additional Information:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.