Senior Associate, Product Development Quality Assurance-Hybrid, Chicago

About the role

This role is primarily responsible for supporting AbbVie's pipeline, by supporting batch disposition activities and ensuring high-quality clinical supplies that are compliant with global regulatory requirements and standards are delivered to patients. This is achieved by effectively partnering with the business, ensuring risks are mitigated appropriately and supporting efficient review of clinical supply batches to support continued uninterrupted access to clinical supplies.

The successful candidate will be able to manage multiple tasks and adjust priorities based on supply needs. This position requires the ability to positively interact with multiple functional areas quickly and effectively resolve batch record documentation related issues independently, ensuring schedules are maintained and material is readily available.

Responsibilities

• Review and approve batch records and release batches or analytical records. Write/ review/ approve processes/procedures and related documents.
• Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, and R&D GxP Compliance.
• Provide quality approvals in the materials management system as defined by procedures. Write, review and/or approve exception documents and product complaints (as applicable), corrective actions/preventive actions (CA/PA) and ensure they meet timeliness requirements.
• Review/approve clinical documentation and specifications, as applicable.
• Actively lead/participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality issues.
• Generate, analyze, and report quality metrics to management. Lead/participate with support groups in developing/prioritizing QA activity timelines.
• Actively monitor the effectiveness of processes and quality of project work with management and propose and execute quality/process improvements.
• Provide quality oversight on the manufacturing floor, as needed.

Qualifications & Requirements

• Bachelor's degree, typically in life sciences (biology, chemistry, or engineering), and/or equivalent experience.
• 4+ years of industry experience in Quality Assurance, production, or testing of active pharmaceutical ingredients, drug products, drug development, or another healthcare-related field; less experience may be considered with an advanced degree.
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide GMP requirements (D, EU, US) is preferred.
• Experience coordinating and planning complex activities.
• Proven organizational skills.
• Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities.
• Effective oral and written communication skills to clearly communicate the quality position and the actions necessary to resolve issues.
• Ability to identify and resolve complex problems through effective use of technical and interpersonal skills.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• 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 short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.