Associate Director, Quality Control — Clinical & Commercial

Xenon Pharmaceuticals; Needham (MA); Hybrid; USD 190,000 - 230,000; Full time

Benefits offered by this job

Base salary plus bonus

Stock options

Medical, dental, vision

Short- and long-term disability

AD&D and life insurance

Employee Assistance Program

Travel insurance

Retirement savings program

Job summary

Xenon Pharmaceuticals invites an experienced Associate Director to lead Quality Control activities across DS/DP programs in line with ICH and cGMP. The role requires managing analytical testing, stability programs, investigations, and collaboration with QA and external labs.

The position is based in Boston, MA, with remote options for exceptional candidates and a hybrid schedule requiring two onsite days weekly.

Qualifications

• Undergraduate life sciences degree with 8+ years of management experience.
• Experience auditing external labs and FDA/EMA inspections preferred.
• Strong QC testing and stability program management per ICH.
• Experience with IND/BLA/CTA CMC submissions preferred; cGMP knowledge.
• Excellent communication and prior teams leadership.
• Willingness to travel up to 20% domestically and internationally.

Responsibilities

• Lead master specifications for starting materials, reference standards, API, and drug products for assigned programs.
• Lead stability activities including data trending, evaluation, and expiry dating justifications.
• Manage stability studies and reference standards with tracking of shelf-life extensions.
• Lead investigations and draft reports for OOS/OOT results during release and stability testing.
• Review and manage all analytical results for release and stability, organize QC data.
• Coordinate reference standard program with external labs, CMOs, and testing facilities.
• Lead QA collaborations on regulatory submissions (IND, CTA, NDA) and transfer protocols.
• Oversee internal release documents for drug substances/products and reference standards.
• Ensure compliance with audits by external labs and CMOs, and participate in remote/on-site audits.
• Support collaboration between Drug Product and API groups for trial material readiness.
• Provide QC knowledge to transfer candidates from discovery to CMC teams.
• Oversee sample movement between labs and CMOs for testing and releases.
• Manage team capacity and performance reviews, plus other duties as needed.

Skills

Quality Control

Project Management

Leadership

Regulatory Knowledge

Cross-functional Collaboration

Communication

Travel Willingness

Education

Bachelor's in Life Sciences

Job description

Xenon Pharmaceuticals invites an experienced Associate Director to lead Quality Control activities across DS/DP programs in line with ICH and cGMP. The role requires managing analytical testing, stability programs, investigations, and collaboration with QA and external labs.

The position is based in Boston, MA, with remote options for exceptional candidates and a hybrid schedule requiring two onsite days weekly.