Quality Senior Manager (Analytical CMC)

AbbVie•Worcester, MA

2d•$124,500 - $236,500

About The Position

AbbVie is seeking a highly skilled Senior Manager to join their dynamic team supporting biologics regulatory submissions. In this role, the Senior Manager will serve as the lead author for key Module 3 Common Technical Document (CTD) sections. They will apply their analytical expertise and regulatory knowledge to deliver high-quality documentation in support of global regulatory submissions. This role is an integral member of cross-functional teams, collaborating closely with Quality Control, Quality Assurance, Regulatory, Analytical Research and Development, and Chemistry, Manufacturing and Controls (CMC) colleagues to deliver submissions to support commercial approval. The ideal candidate will have extensive analytical experience, including authoring of analytical and stability regulatory submission sections, a proven track record of excelling in a fast-paced environment, and outstanding attention to detail.

Requirements

Minimum Bachelor’s Degree required preferably in Chemistry, Physical or Life Sciences, Engineering, or related subject; relevant advanced degree preferred.
8+ years of combined experience in CMC, Manufacturing, QA, QC, R&D in pharmaceutical, or biologics industry.
4+ years of supervisory/technical leadership experience.
Extensive authoring experience with Module 3 CTDs (specifically S.2.3, S.4.2, S.4.3, S.5, S.7) for regulatory submissions.
Proven expertise in analytical/quality control laboratory or CMC regulatory environment.
Strong understanding of global regulatory requirements and ICH guidelines.
Demonstrated ability to work effectively on teams and build collaborative relationships across functions.
Excellent written and verbal communication skills; attention to detail is essential.
Self-motivated, organized, and capable of managing multiple priorities and deadlines independently.
Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, manufactured at the plant.
Must be familiar with use of statistical quality systems and electronic document management system.
Must also be familiar with Quality policies as well as cGMP and other regulatory requirements.

Nice To Haves

relevant advanced degree preferred

Responsibilities

Author and review new applications and amendments for CTD Module 3 sections S.2, S.4, S.5, and S.7 for regulatory submissions (e.g., BLAs, MAAs, INDs, IMPDs, etc).
Support responses to regulatory questions and information requests.
Provide subject matter expertise in analytical methods, method validation, reference standard qualification, and stability studies.
Ensure consistency, accuracy, and compliance of submission documents with current regulatory guidance and company standards.
Remain up to date with regulatory requirements relevant to Module 3 content.
Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise to deliver results within project timelines.
Proactively identify risks and propose solutions for documentation challenges.
Lead cross-functional project meetings to support timelines and project deliverables.
Interact and collaborate with teams to gather and interpret technical data.