Quality Senior Manager (Analytical CMC)

About the role

We are seeking a highly skilled Senior Manager to join our dynamic team supporting biologics regulatory submissions. In this role, you will serve as the lead author for key Module 3 Common Technical Document (CTD) sections. You will apply your analytical expertise and regulatory knowledge to deliver high-quality documentation in support of global regulatory 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 (CMC) colleagues to deliver submissions to support commercial approval.

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.

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.