Product Quality Senior Manager (Science)

Regulatory Jobs; North Chicago (IL); Sur place; USD 120 000 - 160 000; Plein temps

Résumé du poste

AbbVie in North Chicago, IL seeks an experienced Quality Assurance Operations Manager to lead quality activities across product transfers and compliance with FDA and other agencies. You will coordinate with internal teams and third-party manufacturers to ensure on-time delivery and regulatory readiness.

The role emphasizes strong analytical skills, cross-functional collaboration, and a track record in pharmaceutical quality systems, with emphasis on sterile, biologics, and device products.

Qualifications

• Bachelor's Degree in Life Science, Engineering, or a related technical field.
• Total of 8+ years experience: at least 3 years in Quality Assurance Operations Management; 5+ years in Operations, R&D, Regulatory or Consulting.
• Strong understanding of biological/pharmaceutical technologies (sterile, biologics, devices, APIs, etc.).
• Experience with FDA and other regulatory agency interactions and inspections.
• Familiarity with third-party external manufacturing.

Responsabilités

• Maintains primary quality lead for project activities and team members to ensure on-time quality deliverables.
• Participates in global Product Quality Assurance strategy for pharmaceuticals, biologics, devices, and TPM facilities.
• Performs final quality release of manufactured product lots.
• Provides recommendations on quality and regulatory conformance and elevates high-risk events.
• Interfaces with external manufacturers and AbbVie plants to identify quality concerns and allocate resources.
• Leads audit readiness and pre-approval inspections for third-party manufacturers to ensure regulatory approvals without delays.

Connaissances

Quality Assurance

Operations Management

Regulatory Interactions

Analytical Skills

Formation

Bachelor's Degree

Description du poste

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.

Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands. Grade is commensurate on level of overall responsibility.

Responsibilities

• Maintains the primary quality lead with management oversight for project activities and the team members (within and outside of AbbVie) to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of product transfers and organization optimization.
• Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third party manufacturing (TPM) facilities. Implements agreed strategy.
• Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers.
• Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to AbbVie management. Ensures alignment of Quality and Technical Agreements with the legal contracts and that their commitments are being fulfilled.
• Establishes and maintains relationships and open communication with Third Party Manufacturers, AbbVie plants, affiliates and other functional groups to identify potential projects and issues, understand quality, compliance, and resource needs at each site and provide guidance on quality concerns.
• Communicates and negotiates with external companies' quality organizations to maintain a consistent level of quality and minimize compliance risks while balancing cost. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.
• Interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Leads and manages pre-approval inspection readiness for third party manufacturers to ensure regulatory approvals are obtained with no delays to market entries.
• Contributes to Quality Assurance elements needed to facilitate new product launches. Coordinates follow-up on complaint trend investigations for non-medical and medical (adverse events). Supports the management of exception documents and Corrective and Preventive Actions.
• Completes management reviews with assigned Third Party Manufacturers. Obtains and reviews summaries of Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) to ensure accuracy, completeness, timeliness, and that trends are identified and addressed.

Qualifications

• Bachelor's Degree in relevant Life Science, Engineering, or other technical discipline required. Technical or Analytical background required.
• Minimum 8+ years total combined experience: at least 3 years in Quality Assurance Operations Management; 5+ years in Operations, R&D, Regulatory or Consulting. Direct Manufacturing Plant experience in a Pharmaceutical setting is preferred.
• Comprehensive understanding of biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid dose, suspensions, extended release products, APIs, etc.).
• Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required.
• Experience with FDA and other regulatory agency interactions and inspections is required.
• Familiarity with the requirements for third party external manufacturing.
• Strong analytical and problem solving skills, positive interpersonal skills, and ability to manage multiple complex tasks with a high degree of urgency.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) for eligible employees
• Eligible for long-term incentive programs

AbbVie is an equal opportunity employer. Equal Opportunity Employer/Veterans/Disabled.