Energy Jobline ZR
Senior Project Manager, QA in North Chicago
Energy Jobline ZR, North Chicago, Illinois, us, 60086
Company
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 – immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit www.abbvie.com.
Purpose Responsible for the quality of assigned products which may include small‑molecule pharmaceuticals, biologics, combination products and medical devices to ensure business objectives are met with regards to on‑time delivery while assuring compliance to local, divisional, corporate policies and external agency regulations worldwide.
Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), intermediates or drug products produced by AbbVie plants or by third‑party manufacturers, in licensing relationships or co‑marketing relationships. Develops in concert with Regulatory Affairs the appropriate regulatory strategies for product brands.
Responsibilities
Maintains the primary quality lead with management oversight for project quality activities and the team members (within and outside of AbbVie) to achieve on‑time quality deliverables, high customer value, and profitable results.
Leads the development of global product quality assurance strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third‑party manufacturing facilities.
Makes key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to AbbVie management.
Ensures alignment of quality and technical agreements with legal contracts and that the commitments of the quality and technical agreements are being fulfilled.
Establishes and maintains relationships and open communication with third‑party manufacturers, AbbVie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in‑depth understanding of the quality, compliance and resource needs at each site and provide guidance on quality concerns.
Communicates and negotiates with external companies’ quality organization to maintain a consistent level of quality and a level of expectation that will minimise compliance risks while balancing cost of operating.
Interfaces with quality assurance audit team to develop audit plans, due diligence plans and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable.
Manages quality assurance elements needed to facilitate new product launches, including third‑party manufacturer activities and product transfer processes from R&D to AbbVie sites.
Supports the management of exception documents and corrective and preventive actions and coordinates input from technical groups to determine root cause and implement appropriate actions.
Develops product quality transfer process monitoring metrics and maintains departmental spend within budget.
Supports regulatory filings and marketing authorization dossiers by developing and reviewing chemistry, manufacturing and controls documents, drug master files and certificates; works with AbbVie affiliates and regulatory teams to prepare submissions.
Qualifications
Bachelor’s Degree in a relevant life science, engineering or other technical discipline required.
Minimum 8+ years of combined experience: at least 3 years in quality assurance operations management; 5+ years in operations, research and development, regulatory or consulting.
Direct manufacturing plant experience in a pharmaceutical setting.
Comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets, suspensions, capsules, gel caps, extended‑release products, coating solutions, and/or active pharmaceutical ingredients).
Strong background in quality assurance/control, manufacturing, laboratory, technical support, regulatory and/or validation.
Experience with FDA and other regulatory agency interactions and inspections.
Familiarity with requirements for third‑party external manufacturing.
Capability to operate within an environment requiring high urgency, strong analytical and problem‑solving skills, positive interpersonal skills, and the ability to manage multiple complex tasks simultaneously; capable of performing as a leader, team member and individual contributor.
Key Stakeholders External manufacturing business relationships, operations, third‑party manufacturers, business alliance, commercial, global supply chain, domestic and international AbbVie plants and affiliates, regulatory affairs, research and development.
Additional Information
The compensation range described 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 the position. Individual compensation paid within this range will depend on many factors including geographic location.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short‑term incentive programs.
This job is eligible to participate in our long‑term incentive programs.
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
If you are interested in applying for this job, please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr
Purpose Responsible for the quality of assigned products which may include small‑molecule pharmaceuticals, biologics, combination products and medical devices to ensure business objectives are met with regards to on‑time delivery while assuring compliance to local, divisional, corporate policies and external agency regulations worldwide.
Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), intermediates or drug products produced by AbbVie plants or by third‑party manufacturers, in licensing relationships or co‑marketing relationships. Develops in concert with Regulatory Affairs the appropriate regulatory strategies for product brands.
Responsibilities
Maintains the primary quality lead with management oversight for project quality activities and the team members (within and outside of AbbVie) to achieve on‑time quality deliverables, high customer value, and profitable results.
Leads the development of global product quality assurance strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third‑party manufacturing facilities.
Makes key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to AbbVie management.
Ensures alignment of quality and technical agreements with legal contracts and that the commitments of the quality and technical agreements are being fulfilled.
Establishes and maintains relationships and open communication with third‑party manufacturers, AbbVie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in‑depth understanding of the quality, compliance and resource needs at each site and provide guidance on quality concerns.
Communicates and negotiates with external companies’ quality organization to maintain a consistent level of quality and a level of expectation that will minimise compliance risks while balancing cost of operating.
Interfaces with quality assurance audit team to develop audit plans, due diligence plans and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable.
Manages quality assurance elements needed to facilitate new product launches, including third‑party manufacturer activities and product transfer processes from R&D to AbbVie sites.
Supports the management of exception documents and corrective and preventive actions and coordinates input from technical groups to determine root cause and implement appropriate actions.
Develops product quality transfer process monitoring metrics and maintains departmental spend within budget.
Supports regulatory filings and marketing authorization dossiers by developing and reviewing chemistry, manufacturing and controls documents, drug master files and certificates; works with AbbVie affiliates and regulatory teams to prepare submissions.
Qualifications
Bachelor’s Degree in a relevant life science, engineering or other technical discipline required.
Minimum 8+ years of combined experience: at least 3 years in quality assurance operations management; 5+ years in operations, research and development, regulatory or consulting.
Direct manufacturing plant experience in a pharmaceutical setting.
Comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets, suspensions, capsules, gel caps, extended‑release products, coating solutions, and/or active pharmaceutical ingredients).
Strong background in quality assurance/control, manufacturing, laboratory, technical support, regulatory and/or validation.
Experience with FDA and other regulatory agency interactions and inspections.
Familiarity with requirements for third‑party external manufacturing.
Capability to operate within an environment requiring high urgency, strong analytical and problem‑solving skills, positive interpersonal skills, and the ability to manage multiple complex tasks simultaneously; capable of performing as a leader, team member and individual contributor.
Key Stakeholders External manufacturing business relationships, operations, third‑party manufacturers, business alliance, commercial, global supply chain, domestic and international AbbVie plants and affiliates, regulatory affairs, research and development.
Additional Information
The compensation range described 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 the position. Individual compensation paid within this range will depend on many factors including geographic location.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short‑term incentive programs.
This job is eligible to participate in our long‑term incentive programs.
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
If you are interested in applying for this job, please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr