Senior Associate, Product Development Quality Assurance

Regulatory Jobs; Chicago (IL); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

PTO (paid time off)

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie is seeking a qualified QA professional to support AbbVie’s pipeline by reviewing batch records, releasing analytical records, and ensuring clinical supplies meet global regulatory standards. You will collaborate across functions to mitigate risks and support timely, compliant delivery of materials.

The role requires managing multiple tasks, coordinating audits, and maintaining schedules while addressing batch documentation issues and driving quality improvements across manufacturing and

Qualifications

• Bachelor’s degree 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.
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide GMP requirements (D, EU, US).
• 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.

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.

Skills

Quality mindset

Regulatory knowledge

Communication skills

Leadership & teamwork

Problem solving

Attention to detail

Education

Bachelor’s degree in life sciences or engineering

Tools

Materials management system (MMS)

GxP compliance software

Job description

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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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.

• 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.

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Company’s sole and absolute discretion, consistent withapplicable law.

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html