Quality Senior Manager

Role Summary

We are seeking a highly skilled Senior Manager to join the biologics regulatory submissions team. You will serve as the lead author for key Module 3 CTD sections and apply regulatory knowledge to deliver high-quality documentation for global submissions. You will be an integral member of cross-functional teams, collaborating closely with Quality Control, Quality Assurance, Regulatory, Analytical Research and Development, and Chemistry, Manufacturing and Controls colleagues to deliver submissions to support commercial approval. The ideal candidate has extensive analytical experience, including authoring analytical and stability regulatory submission sections, and thrives in a fast-paced environment with outstanding attention to detail.

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.

Qualifications

• 8+ years of combined experience in CMC, Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry.
• 4+ years of supervisory or 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.

Education

• Bachelor’s degree in Chemistry, Physical or Life Sciences, Engineering, or related subject; advanced degree preferred.