Manager, QA & Continuous Improvement

BioSpace; North Chicago (IL); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Benefits package

Long-term incentive programs

Job summary

AbbVie is seeking a Manager of Quality Assurance & Continuance Improvement to lead the QA team, oversee the Quality System, CAPA program and MRB, and drive data-driven improvements across the function.

The role requires a Bachelor's degree and 5+ years in quality assurance with at least 3 years in management, plus strong collaboration and Six Sigma preference. Excellent communication with senior leaders is essential.

Qualifications

• Bachelor's degree in business, physical or life science, pharmacy, nursing, engineering or related field if combined with relevant work experience
• 5+ years experience in quality assurance, service center or technical field in a regulated industry or relevant experience
• 3+ years of managerial and/or project management experience in a quality assurance, or similar organization highly desired
• Knowledge of AbbVie Quality System, or similar, specifically governing policies and procedures related to Quality Assurance best practices
• Experience driving key process improvement initiatives based on data-driven insights and key performance indicators (KPIs)
• Ability to represent the Quality function effectively with senior managers, other AbbVie and external professionals
• Strong communication skills and ability to effectively collaborate with stakeholders across the organization
• Six Sigma / continuous improvement methodology, certification, or experience is preferred
• Regulatory, compliance, and/or information security experience is desired

Responsibilities

• Manages the Quality Assurance team, responsible for selection and hiring, setting performance expectations, and development of staff.
• Assists with the overall development and implementation of organizational Performance Improvement (PI) plan, including identification of PI goals, coordinating and participating in PI projects, and reporting activities and outcomes.
• Manages investigations (ERs), including oversight of complaints, non-conformances, CAPA and deviations, identifying improvements and responding to trends.
• Manages quality and performance metrics and KPIs for the larger function, utilizingtrend and data analytics to prioritize areas of opportunity, and leading projects and efforts to drive improvements.
• Reviews, and approves, Quality System documents and records.
• Manages organizational Risk Management process, partnering with OEC and BTS in driving improvement in privacy and security efforts.
• Supports internal and external audits, provides audit responses, and develops improvement plans based on audit feedback.
• Responsible for monthly Management Review Board (MRB) meeting, collaborating with quality team and larger organization in presenting quality trends, remediation efforts, and impact metrics.
• Oversees monitoring tools and supports expansion of automated quality monitoring and analytics where appropriate. Support other functional quality initiatives, programs and systems as required.

Skills

Quality Assurance

Project Management

Data Analytics

Six Sigma

Regulatory Compliance

Communication

Education

Bachelor's degree

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

The Manager, Quality Assurance & Continuance Improvement holds the responsibility of managing the Quality Assurance team across the function. The role is responsible for the direct oversight of the Quality System, including owning and operating the Monthly Review Board (MRB), CAPA program, and managing all aspects of the Quality Monitoring program. The role is also responsible for maintaining the documentation control system to ensure proper controls and accountability and support internal and external audits. The positions manages the quality and continuous improvement strategy, while managing an organization of quality assurance and data-driven insights personnel.

Responsibilities

• Manages the Quality Assurance team, responsible for selection and hiring, setting performance expectations, and development of staff.


• Assists with the overall development and implementation of organizational Performance Improvement (PI) plan, including identification of PI goals, coordinating and participating in PI projects, and reporting activities and outcomes.


• Manages investigations (ERs), including oversight of complaints, non-conformances, CAPA and deviations, identifying improvements and responding to trends.


• Manages quality and performance metrics and Key Performance Indicators (KPIs) for the larger function, utilizing trend and data analytics to prioritize areas of opportunity, and leading projects and efforts to drive improvements.


• Reviews, and approves, Quality System documents and records.


• Manages organizational Risk Management process, partnering with OEC and BTS in driving improvement in privacy and security efforts.


• Supports internal and external audits, provides audit responses, and develops improvement plans based on audit feedback.


• Responsible for monthly Management Review Board (MRB) meeting, collaborating with quality team and larger organization in presenting quality trends, remediation efforts, and impact metrics.


• Oversees monitoring tools and supports expansion of automated quality monitoring and analytics where appropriate. Support other functional quality initiatives, programs and systems as required.

Qualifications

• Bachelors degree in business, physical or life science, pharmacy, nursing, engineering or related field if combined with relevant work experience


• 5+ years experience in quality assurance, service center or technical field in a regulated industry or relevant experience


• 3+ years of managerial and/or project management experience in a quality assurance, or similar organization highly desired


• Knowledge of AbbVie Quality System, or similar, specifically governing policies and procedures related to Quality Assurance best practices


• Experience driving key process improvement initiatives based on data-driven insights and key performance indicators (KPIs)


• Ability to represent the Quality function effectively with senior managers, other AbbVie and external professionals


• Strong communication skills and ability to effectively collaborate with stakeholders across the organization


• Six Sigma / continuous improvement methodology, certification, or experience is preferred


• Regulatory, compliance, and/or information security experience is desired

Additional Information

• 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 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