Quality Systems Manager

BioSpace; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

PTO & Holidays

Medical/Dental/Vision Insurance

401(k)

Job summary

AbbVie in North Chicago, IL seeks a Manager Quality Systems to provide QA support across pharmaceutical, biologics, cosmetics and device products. The role translates strategy into tactical objectives to meet regulatory requirements and ensure product quality from raw material inspection through shipment.

The position oversees supplier qualification, change management, ASL governance, training programs, and audits by FDA, EMA and internal teams, with leadership of cross-functional professionals.

Qualifications

• Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or related field.
• 8+ years in quality assurance or related.
• Experience leading cross-functional teams.
• Knowledge of QA systems and GMP.
• Strong communication and collaboration skills.

Responsibilities

• Ensure quality regulations across drug, biologics, cosmetics, device and/or combination products.
• Lead cross-functional project teams for quality documentation.
• Maintain effectiveness of the quality system per policies and regulations.
• Design quality systems and processes to ensure compliance and efficiency.
• Coordinate training and audits (FDA, EMA, internal).
• Interact with internal and external partners to share best practices.
• Perform assessments to identify gaps and drive improvements.
• Oversee training programs for quality assurance.

Skills

Leadership of cross-functional teams

Quality assurance

Regulatory knowledge

Communication skills

Project management

Education

Bachelor's Degree in Chemistry/Pharmacy/Biology/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 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.

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 401(k) to eligible employees

This job is eligible to participate in our long-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.

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