Senior Manager - Product Development Quality Assurance (CMC Product Lead)
To see similar active jobs please follow this link: Remote Management jobs
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 products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Primarily responsible for ensuring the timely release of GMP clinical supplies by providing direction and quality oversight of the supply chain including, manufacturing, testing and release processes from drug substance to drug product to finished product. As a team member in interdisciplinary product development teams (e.g., CMC teams), the Senior Manager is responsible for early identification and prevention of pipeline risks by driving consensus-building across AbbVie R&D functions and external partners.
Responsibilities:
QA representative for CMC product development teams to facilitate the approval of drug to clinical trials according to program timelines.
Provide program oversight for the RDQA QA organization; includes timely communications on program strategies, issue and risk management.
Lead complex global cross-functional process improvement teams.
Provide innovative and risk-based solutions to complex technical problems.
Support the preparation of regulatory inspections and internal audits and represent Quality in inspections and audits.
Write/ review/ approve exception reports, including high impact and complex investigations impacting multi-functional areas.
Provide management of clinical supply product actions and stock recovery.
Conduct the onboarding of new assets.
Perform due diligence of potential assets.
Ensure suitable quality agreements or quality aspects of contracts are in place between R&D and third-party manufacturers, third party laboratories, and other service providers.
Interact with and influence decision making at the senior leadership level as well as with external customers.
This role can be remote within the US.
Qualifications
· Bachelors in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
· Master’s degree is preferred but is not required based on commensurate experience.
· Minimum 8+ years of industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree.
· A broad understanding of pharmaceutical manufacturing processes (chemical and biological) and analytical sciences.
· Strong knowledge of global GMP requirements (EU, US, etc.) and international pharmaceutical law.
· Experience applicable to investigational products is preferred.
· Experience in project management and ability to manage multiple priorities. Project Management Professional (PMP) certification is preferred, but not required.
· Strong leadership, communication, and organizational skills.
· Must be able to provide and defend the quality position and effectively solve complex technical and quality issues.
· Must have a team-oriented work style and strong collaboration skills.
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
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
About the job
Senior Manager - Product Development Quality Assurance (CMC Product Lead)
To see similar active jobs please follow this link: Remote Management jobs
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 products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Primarily responsible for ensuring the timely release of GMP clinical supplies by providing direction and quality oversight of the supply chain including, manufacturing, testing and release processes from drug substance to drug product to finished product. As a team member in interdisciplinary product development teams (e.g., CMC teams), the Senior Manager is responsible for early identification and prevention of pipeline risks by driving consensus-building across AbbVie R&D functions and external partners.
Responsibilities:
QA representative for CMC product development teams to facilitate the approval of drug to clinical trials according to program timelines.
Provide program oversight for the RDQA QA organization; includes timely communications on program strategies, issue and risk management.
Lead complex global cross-functional process improvement teams.
Provide innovative and risk-based solutions to complex technical problems.
Support the preparation of regulatory inspections and internal audits and represent Quality in inspections and audits.
Write/ review/ approve exception reports, including high impact and complex investigations impacting multi-functional areas.
Provide management of clinical supply product actions and stock recovery.
Conduct the onboarding of new assets.
Perform due diligence of potential assets.
Ensure suitable quality agreements or quality aspects of contracts are in place between R&D and third-party manufacturers, third party laboratories, and other service providers.
Interact with and influence decision making at the senior leadership level as well as with external customers.
This role can be remote within the US.
Qualifications
· Bachelors in life sciences (biology, chemistry, or engineering) and/or equivalent experience.
· Master’s degree is preferred but is not required based on commensurate experience.
· Minimum 8+ years of industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree.
· A broad understanding of pharmaceutical manufacturing processes (chemical and biological) and analytical sciences.
· Strong knowledge of global GMP requirements (EU, US, etc.) and international pharmaceutical law.
· Experience applicable to investigational products is preferred.
· Experience in project management and ability to manage multiple priorities. Project Management Professional (PMP) certification is preferred, but not required.
· Strong leadership, communication, and organizational skills.
· Must be able to provide and defend the quality position and effectively solve complex technical and quality issues.
· Must have a team-oriented work style and strong collaboration skills.
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
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