Senior Director of Quality and Analytical Development

Job Overview

The Senior Director of Quality Assurance and Analytical Development is responsible for leading and executing QA strategy and analytical development activities to support the development and registration of oral and injectable drug products. This role ensures compliance with global regulatory standards (FDA, EMA, NMPA, ICH) while building robust analytical methods, stability programs, and quality systems across development and manufacturing. The candidate will be based in Doylestown, PA.

Responsibilities

Quality Assurance (QA)

• Establish and maintain GMP-compliant quality systems supporting drug substance, drug product development and manufacturing.
• Provide QA oversight for: analytical method development and validation, stability studies, drug substance and drug product manufacturing CDMO and CRO activities, raw material and clinical supply activities
• Lead quality risk management (ICH Q9), deviations, CAPAs, change control, and investigations.
• Support regulatory inspections and audits (FDA, EMA, client audits).
• Review and approve SOPs, protocols, reports, and specifications, batch records and quality agreements
• Ensure QA alignment with ICH Q7, Q8, Q10, and Q11 guidelines.

Analytical Development

• Lead analytical development strategy for oral and injectable dosage forms.
• Oversee development, qualification, validation and transfer of: HPLC/UPLC, GC, LC-MS methods, Dissolution, content uniformity, and impurity profiling, Stability-indicating methods, microbiology methods, cleaning validation methods
• Ensure methods are phase-appropriate for early-stage clinical development
• Guide specification setting for drug substance and drug product.
• Ensure data integrity (ALCOA+) and lifecycle management of analytical methods.

Regulatory & CMC Support

• Contribute to IND, NDA, and MAA submissions (Module 3).
• Act as QA/analytical SME for regulatory interactions.

Leadership & Strategy

• Manage external vendors (CDMOs, analytical labs).
• Build and lead QA and analytical development team as portfolio expands
• Mentor staff and foster a culture of quality and scientific rigor.

Qualifications

• PhD, MS, or BS in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related field
• 10+ years in pharmaceutical QA and/or analytical development experience
• Strong experience with oral drug products (solid and/or liquid)
• Direct experience supporting IND/NDA filings, and regulatory inspections
• Proven experience working with CDMOs, vendor and stakeholder management
• Proven experience in analytical method development and validation (ICH Q2), stability program design (ICH Q1), dissolution, GMP and data integrity compliance and regulatory documentation and inspection readiness.
• Strong Strategic thinking with hands-on execution ability.High attention to detail and scientific rigor.
• Up to 10% of domestic or international travel is required.
• Experience with oral peptides or enabling technologies (e.g., permeation enhancers, modified release) is preferred.