Quality Control Senior Manager - Clinical/Commercial DS/DP

Xenon Pharmaceuticals Inc.; Boston, Northern (MA, KY); Hybrid; USD 130,000 - 190,000; Full time

Benefits offered by this job

Stock options

Medical insurance

Dental insurance

Tuition Assistance

Job summary

Xenon Pharmaceuticals Inc. is seeking an experienced Senior Manager/Associate Director, Quality Control to lead QC activities for clinical and commercial drug substances and products.

The role spans early to late clinical phases through PPQ and registration, requiring oversight of testing, stability, reference standards, investigations, and regulatory collaboration. Based in either Boston, MA or Vancouver, BC (Needham office in USA), the role is hybrid with two onsite days weekly minimum.

Qualifications

• Undergraduate life sciences degree required.
• 5+ years in pharmaceutical QC management (Senior Manager) or 8+ years (Associate Director).
• Experience with small molecules and clinical to commercial programs preferred.
• Experience auditing external labs; FDA/EMA inspections preferred.

Responsibilities

• Lead analytical/non-analytical release and stability data review.
• Manage stability studies and trend analysis across DS/DP programs.
• Oversee reference standards program and master specifications.
• Lead investigations for OOS/OOT and draft comprehensive reports.
• Coordinate regulatory submission support for CMC sections.

Skills

Quality control

Stability program

OOS/OOT investigations

Regulatory submissions

Cross-site collaboration

Audits (FDA/EMA)

Team leadership

Education

Life sciences degree

Tools

ICH guidelines

Job description

Xenon Pharmaceuticals Inc. is seeking an experienced Senior Manager/Associate Director, Quality Control to lead QC activities for clinical and commercial drug substances and products.

The role spans early to late clinical phases through PPQ and registration, requiring oversight of testing, stability, reference standards, investigations, and regulatory collaboration. Based in either Boston, MA or Vancouver, BC (Needham office in USA), the role is hybrid with two onsite days weekly minimum.