Quality Systems Manager

AbbVie Inc.; North Chicago (IL); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Paid time off

Job summary

Working with R&D, manufacturing, regulatory affairs and other functions, you will implement and maintain high quality standards and lead audits to ensure continued compliance and process improvements.

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or related technical field.
• 8+ years’ experience in quality assurance or related roles.
• Experience leading cross-functional teams.
• Strong knowledge of QA, Regulatory, Process Sciences, Manufacturing Operations.
• Familiarity with QA systems and GMP for device, biologics, and pharmaceutical products.
• Ability to work independently and with guidance from management.
• Excellent verbal and written communication skills.
• Strong interpersonal skills; able to lead projects of increasing size.

Responsibilities

• Ensure proper integration and support of quality regulations across products.
• Lead project teams in planning, preparation, review and approval of quality documentation.
• Implement and maintain the effectiveness of the quality system for multiple product types.
• Design effective quality systems and processes within cross functional teams.
• Prepare and present data during regulatory audits (FDA, EMA, etc.) and internal audits.
• Coordinate quality system elements, training, and continuous improvement across functions.
• Support new product introduction and design changes for devices and biotech products.
• Interact with partners to develop best practices in quality systems.
• Perform assessments to identify gaps and implement improvements.
• Oversee training and education programs for quality assurance.

Skills

Leadership

Cross-functional teams

Communication skills

Quality assurance

GMP knowledge

Regulatory knowledge

Education

Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering

Job description

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Manager Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, cosmetics, combination products and biologics. This role will support the strategic direction to ensure business objectives are met. Specific areas of responsibility may include supplier qualification and approval, supplier risk management, , supplier change management, , and Approved Supplier List (ASL) governance. This position will also translate strategy into tactical objectives to deliver strategic plans and regulatory updates. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.

Responsibilities

• Ensure proper integration and support of quality regulations: drug, biologics, cosmetic, device and/or combination products.
• Lead project teams in planning, preparation, review and approval of quality documentation.
• Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, cosmetic, device and/or combination products including compliance with Corporate policies, processes and procedures.
• Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
• Manage and oversee the interrelated function activities including design control with R&D, Manufacturing Science and Technology (MS&T), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs.
• Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.
• Support new product introduction for pharmaceutical products, medical devices, or combination products. Support design changes to existing medical devices and combination products.
• Interact with internal and external partners for development of best practices in our quality systems and procedures.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
• Oversee the implementation and management of training and education programs for various aspects of quality assurance.

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
• 8+ years’ experience in quality assurance, quality oversight or relevant experience.
• Leadership of technical professionals and in leading cross-functional teams.
• Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
• Experience working in both team setting and independently. Works well with manager guidance while able to manage own time.
• Strong oral (with all levels of management) and written communication skills needed.
• Excellent interpersonal skills a plus.
• Can lead medium to larger sized projects with increasing level of complexity and size to deliver tactical results that support strategic initiatives.

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 this posting 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 and until paid andmay bemodifiedat 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