Director, Quality Control
Omeros Corporation
August 25, 2026
On-site
Seattle, WA
$210,000 - $245,000 USD yearly
Operations
Responsibilities:
- Lead Quality Control (QC) activities for clinical and commercial products, including management of in-process and release testing of GMP products.
- Lead and manage QC staff (hiring, development, evaluation, goal setting).
- Oversee GMP stability planning, execution, statistical data analysis, and data trending for product expiry/shelf-life.
- Oversee QC requirements for cGMP compliance at external contract manufacturing and testing organizations.
- Oversee product release and stability specification setting and COA generation.
- Oversee and approve QC components of GMP manufacturing batch and test records at external contract organizations.
- Define QC strategy and roadmap in conjunction with analytical methods and manufacturing process development.
- Partner to transfer, qualify, and validate analytical methods.
- Establish and maintain QC standards for clinical and commercial phases.
- Author/review relevant regulatory filing sections and submissions.
- Drive continuous improvement projects with internal/external stakeholders.
Qualifications/Requirements:
- PhD in Analytical Chemistry, Biochemistry, Biology, or related field.
- 10+ years QC experience, preferably with biologics and small molecules.
- Strong knowledge of GMPs, ICH guidelines, and quality management systems.
Preferred Skills/Experience:
- Analytical methods technology transfer to third parties.
- Regulatory authority meetings and GMP site inspection experience.
- Analytical method development/validation; stability testing, data trending, and expiry-setting strategy expertise.
- Experience testing injectable and oral dosage forms.
- Big pharma/biotech experience (startup biopharma desirable).
- Proficiency in MS Office (Word/Excel); statistical analysis software desirable.
Benefits/Compensation:
- Salary range: $210,000–$245,000; medical, dental, vision, life insurance, 401(k) with company match; 3 weeks vacation, 80 hours sick time, 12 paid holidays; eligible for incentive and stock options.
Other:
- Travel required: ~10%.
Supervisory Responsibilities:
- Manage a small team and contractors; includes interviewing, hiring/training, work planning/assignment, performance appraisal, and addressing issues.
Behavioral Competencies:
- Build and maintain collaborative relationships.
- Strong written/oral communication and employee development.
- Self-motivated, detail-oriented, high integrity.
- Lead Quality Control (QC) activities for clinical and commercial products, including management of in-process and release testing of GMP products.
- Lead and manage QC staff (hiring, development, evaluation, goal setting).
- Oversee GMP stability planning, execution, statistical data analysis, and data trending for product expiry/shelf-life.
- Oversee QC requirements for cGMP compliance at external contract manufacturing and testing organizations.
- Oversee product release and stability specification setting and COA generation.
- Oversee and approve QC components of GMP manufacturing batch and test records at external contract organizations.
- Define QC strategy and roadmap in conjunction with analytical methods and manufacturing process development.
- Partner to transfer, qualify, and validate analytical methods.
- Establish and maintain QC standards for clinical and commercial phases.
- Author/review relevant regulatory filing sections and submissions.
- Drive continuous improvement projects with internal/external stakeholders.
Qualifications/Requirements:
- PhD in Analytical Chemistry, Biochemistry, Biology, or related field.
- 10+ years QC experience, preferably with biologics and small molecules.
- Strong knowledge of GMPs, ICH guidelines, and quality management systems.
Preferred Skills/Experience:
- Analytical methods technology transfer to third parties.
- Regulatory authority meetings and GMP site inspection experience.
- Analytical method development/validation; stability testing, data trending, and expiry-setting strategy expertise.
- Experience testing injectable and oral dosage forms.
- Big pharma/biotech experience (startup biopharma desirable).
- Proficiency in MS Office (Word/Excel); statistical analysis software desirable.
Benefits/Compensation:
- Salary range: $210,000–$245,000; medical, dental, vision, life insurance, 401(k) with company match; 3 weeks vacation, 80 hours sick time, 12 paid holidays; eligible for incentive and stock options.
Other:
- Travel required: ~10%.
Supervisory Responsibilities:
- Manage a small team and contractors; includes interviewing, hiring/training, work planning/assignment, performance appraisal, and addressing issues.
Behavioral Competencies:
- Build and maintain collaborative relationships.
- Strong written/oral communication and employee development.
- Self-motivated, detail-oriented, high integrity.