Associate Director, Quality Control & Regulatory Submissions

Xenon Pharmaceuticals; Boston (MA); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

Stock options

Tuition assistance

Job summary

Xenon Pharmaceuticals seeks an experienced Associate Director of Quality Control to lead analytical testing and stability activities for clinical and commercial drug substances and products. The role emphasizes cross-functional collaboration, regulatory readiness, and a data-driven, fast-paced environment.

Based in Boston, MA with potential for remote locations for exceptional candidates; hybrid work requires two onsite days per week.

Qualifications

• 8+ years of relevant management experience in pharmaceutical industry (small molecules and/or biologics).
• Experience with external testing laboratories; capable of working across locations/time zones.
• Auditing external laboratories and inspection readiness is preferred.

Responsibilities

• Lead stability and release testing oversight for DS/DP programs.
• Manage master specifications, reference standards, and investigative reporting.
• Coordinate with CMOs and external labs; ensure compliance with ICH/gCMP and regulatory submissions.

Skills

Quality control

ICH guidelines

cGMP

Team leadership

External labs coordination

Education

Undergraduate degree in life sciences

Tools

Quality systems

Job description

Xenon Pharmaceuticals seeks an experienced Associate Director of Quality Control to lead analytical testing and stability activities for clinical and commercial drug substances and products. The role emphasizes cross-functional collaboration, regulatory readiness, and a data-driven, fast-paced environment.

Based in Boston, MA with potential for remote locations for exceptional candidates; hybrid work requires two onsite days per week.