Manager, Product Development Quality Assurance

BioSpace; North Chicago (IL); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k)

Paid time off

Long-term incentive programs

Job summary

AbbVie is seeking a seasoned QA professional to support batch disposition and ensure high-quality clinical supplies aligned with global regulatory standards. The role requires interaction with multiple functional teams, mentorship, and proactive resolution of batch documentation issues to maintain schedules and ensure material availability.

Responsibilities include reviewing records, contributing to audits, and implementing process improvements across PDQA.

Qualifications

• Bachelor's degree in life sciences, chemistry, or engineering or equivalent experience.
• 6+ years in QA, production, or testing of APIs, drug products, or related healthcare fields.
• Strong problem-solving skills and ability to defend quality positions.

Responsibilities

• Review and approve batch records and release entries.
• Lead audits conducted by regulatory agencies and customers.
• Review regulatory changes and update SOPs accordingly.
• Provide management support and backup for routine QA activities.
• Support daily product release activities and drive process improvements.

Skills

Quality Assurance

GxP Compliance

Analytical Sciences

Global GMP

Education

Bachelor's degree

Master's degree preferred

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Company 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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

This role is primarily responsible for supporting AbbVies 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, mentor and coach peers, and quickly and effectively be able 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.
• Review draft and final regulation for impact to R&D business and incorporate procedural changes as necessary.
• Provide routine area specific management support (act as backup to manager for routine management activities).
• Support daily product release activities as applicable to the organization.
• Responsible for driving consistency and continual process improvements within PDQA through assessment and compliance of regulations and industry practice.
• Write/ review/ approve exception reports, including high impact and complex ERs impacting multifunctional areas.
• Actively lead/participate on assigned project team(s) to support the product development.
• Actively monitor the effectiveness of processes and quality of project work with management and propose and execute quality/process improvements.

Qualifications

• Bachelors (typically in life sciences (biology, chemistry, or engineering) and/or equivalent experience).
• Masters degree is preferred but is not required based on commensurate experience.
• 6+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree.
• Supervisory/ project management experience is a plus (not required)
• Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide -global requirements for GMP (D, EU, US) is preferred.
• Must be able to provide and defend the quality position, and effectively problem solve complex technical and quality issues.

Additional Information

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 the timeof thisposting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemayultimatelypaymore or less than the posted range.This range may bemodifiedin 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 toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless anduntil paid andmay bemodifiedat the Companys 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, visithttps://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