Senior Manager, Quality Control (DS/DP) – Clinical/Commercial

Xenon Pharmaceuticals; Needham (MA); Hybrid; USD 170,000 - 210,000; Full time

Benefits offered by this job

Stock options

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

Employee Assistance Program

Travel insurance

Retirement savings plan

Job summary

Xenon Pharmaceuticals, headquartered in Needham/Boston area, seeks an experienced Senior Manager/Associate Director, Quality Control to lead QC activities for DS/DP programs across clinical and commercial stages. The role emphasizes reviewing results, stability management, and collaboration with external labs and CMOs in a fast-paced environment.

Based in Boston, MA in our Needham office, the position offers hybrid onsite requirements with two days per week on-site.

Qualifications

• Bachelor’s degree in life sciences; 5+ years of management experience in the pharmaceutical industry (Senior Manager level) or 8+ years (Associate Director level).
• Experience with external testing labs and compliance programs is required.
• Familiarity with IND/NDA/CTA CMC submissions and cGMP regulatory environments is preferred.

Responsibilities

• Review analytical data for product release and stability; manage OOS/OOT observations.
• Lead stability activities, assess data for shelf-life extensions and risk trends.
• Oversee reference standards programs and master specifications for materials and APIs.

Skills

Quality control

Analytical testing

OOS/OOT handling

GxP compliance

Regulatory submissions

Leadership

Education

Life sciences degree

Job description

Xenon Pharmaceuticals, headquartered in Needham/Boston area, seeks an experienced Senior Manager/Associate Director, Quality Control to lead QC activities for DS/DP programs across clinical and commercial stages. The role emphasizes reviewing results, stability management, and collaboration with external labs and CMOs in a fast-paced environment.

Based in Boston, MA in our Needham office, the position offers hybrid onsite requirements with two days per week on-site.