BioSpace
Manager, Design Quality - Lifecycle Management
Company Description
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 across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. You can follow AbbVie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
This role represents QA on cross‑functional teams and executes Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on the market while assuring compliance with local, divisional & corporate policies and external agency regulations worldwide. Products include medical devices and combination products such as infusion pumps, enteral and sub‑cutaneous tubing, pre‑filled syringes, autoinjectors, eye care products, aesthetic devices, and more.
Responsibilities
Primary driver for the quality and compliance aspects of product transfer and on‑market change management.
Serve as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of AbbVie.
Lead or support process validation activities (IQ/OQ/PQ/PPQ) including TMV.
Mentor and lead product team members through the design transfer process, providing guidance to assure an optimal approach.
Lead or support lifecycle design change projects following Design Control and Change Control principles.
Own change plans to manage on‑market design changes, collaborate with cross‑functional teams for impact assessments, define and execute action plans, and monitor to ensure timely closure.
Ensure design control documentation (traceability, linkages) and design change control requirements are met.
Identify gaps/improvement opportunities within the Design History File and Risk Management, and track to closure.
Assist 3rd‑party suppliers during the change management process, including change management strategies.
Identify gaps in existing processes and the need for new processes; lead cross‑functional teams for solution development and implementation.
Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME.
Participate in the development of global Product Quality Assurance strategy to support device and combination products produced at AbbVie plants as well as contract manufacturing and supplier facilities; implement agreed strategy.
Make recommendations for key decisions on product quality, compliance, and regulatory conformance issues.
Establish and maintain relationships and open communication with suppliers, contract manufacturers, AbbVie plants, affiliates, and other functional groups to maintain roles and responsibilities, identify potential projects and issues, and provide guidance on quality concerns.
Initiate assignments independently; actively lead and participate on development and process improvement teams; anticipate and resolve quality issues and take preventative action.
Actively monitor the effectiveness of processes and quality of project work, propose and execute quality/process improvements. Write, review policies, processes, procedures, and related documents.
Conduct, lead, or participate in investigations and review boards for change plans, CAPAs, NCRs, observations, etc.
Qualifications
Bachelor’s Degree in Life Sciences or a related technical discipline, or equivalent experience.
7+ years of total combined experience; at least 5 years in Quality Assurance Operations Management and 3 years in Operations, Research & Development, or Consulting.
Knowledge and comprehensive understanding of some biological and/or pharmaceutical technologies, including sterile, biological, liquid, ointments, devices, solid tablets & caplets, suspensions, granulations, soft elastic capsules, gel caps, extended‑release products, coating solutions, and/or active pharmaceutical ingredients.
Possesses necessary knowledge and skill set to operate in an environment that requires a high degree of urgency, strong analytical and problem‑solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as a leader, member, and individual.
Working knowledge of ISO 13485, ISO 14971, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR).
Ability to travel up to 10% of the time.
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.
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.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Design, Art/Creative, and Information Technology
Industries Internet News
EEO Statement 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
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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 across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. You can follow AbbVie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
This role represents QA on cross‑functional teams and executes Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on the market while assuring compliance with local, divisional & corporate policies and external agency regulations worldwide. Products include medical devices and combination products such as infusion pumps, enteral and sub‑cutaneous tubing, pre‑filled syringes, autoinjectors, eye care products, aesthetic devices, and more.
Responsibilities
Primary driver for the quality and compliance aspects of product transfer and on‑market change management.
Serve as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of AbbVie.
Lead or support process validation activities (IQ/OQ/PQ/PPQ) including TMV.
Mentor and lead product team members through the design transfer process, providing guidance to assure an optimal approach.
Lead or support lifecycle design change projects following Design Control and Change Control principles.
Own change plans to manage on‑market design changes, collaborate with cross‑functional teams for impact assessments, define and execute action plans, and monitor to ensure timely closure.
Ensure design control documentation (traceability, linkages) and design change control requirements are met.
Identify gaps/improvement opportunities within the Design History File and Risk Management, and track to closure.
Assist 3rd‑party suppliers during the change management process, including change management strategies.
Identify gaps in existing processes and the need for new processes; lead cross‑functional teams for solution development and implementation.
Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME.
Participate in the development of global Product Quality Assurance strategy to support device and combination products produced at AbbVie plants as well as contract manufacturing and supplier facilities; implement agreed strategy.
Make recommendations for key decisions on product quality, compliance, and regulatory conformance issues.
Establish and maintain relationships and open communication with suppliers, contract manufacturers, AbbVie plants, affiliates, and other functional groups to maintain roles and responsibilities, identify potential projects and issues, and provide guidance on quality concerns.
Initiate assignments independently; actively lead and participate on development and process improvement teams; anticipate and resolve quality issues and take preventative action.
Actively monitor the effectiveness of processes and quality of project work, propose and execute quality/process improvements. Write, review policies, processes, procedures, and related documents.
Conduct, lead, or participate in investigations and review boards for change plans, CAPAs, NCRs, observations, etc.
Qualifications
Bachelor’s Degree in Life Sciences or a related technical discipline, or equivalent experience.
7+ years of total combined experience; at least 5 years in Quality Assurance Operations Management and 3 years in Operations, Research & Development, or Consulting.
Knowledge and comprehensive understanding of some biological and/or pharmaceutical technologies, including sterile, biological, liquid, ointments, devices, solid tablets & caplets, suspensions, granulations, soft elastic capsules, gel caps, extended‑release products, coating solutions, and/or active pharmaceutical ingredients.
Possesses necessary knowledge and skill set to operate in an environment that requires a high degree of urgency, strong analytical and problem‑solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as a leader, member, and individual.
Working knowledge of ISO 13485, ISO 14971, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR).
Ability to travel up to 10% of the time.
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.
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.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Design, Art/Creative, and Information Technology
Industries Internet News
EEO Statement 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
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