Associate Director, GMP Quality

Scorpion Therapeutics; Cambridge (MA); On-site; USD 160,000 - 180,000; Full time

Benefits offered by this job

Equity

Bonus

Benefits

Job summary

Scorpion Therapeutics Associate Director, GMP Quality will lead QA activities for GMP release of Clinical Trial Materials and Commercial batches, oversee MP and EQ batch records, and champion regulatory readiness across NDA and commercial launches.

Key responsibilities include CMO oversight, QA metrics generation, and collaboration with QP for product release while driving continuous improvement of Quality Systems and SOPs.

Qualifications

• Bachelor's degree required; MS/PharmD/PhD preferred.
• Extensive understanding of cGMP (21 CFR Parts 210/211), EudraLex Vol. 4, ICH Q7 and related GMP QA guidance.
• Minimum 8 years in an FDA-regulated Pharmaceutical GMP/GMP QA role.
• Experience with NDA/BLA submissions and commercial launches.
• Familiarity with Quality Systems and robust investigations; Health Authority filings and EU QP queries.
• Experience managing CMO relationships and supporting CMO inspections.
• Experience with Quality Management Systems (e.g., Veeva or TrackWise).
• Proficient in Word, Excel, PowerPoint, SharePoint.

Responsibilities

• Batch disposition/release for Clinical Trial Materials and Commercial batches.
• Technical review, quality oversight, and approvals of Master Batch records and Executed Batch records.
• Review/approve CMO deviations, CAPA, and Change Controls; open internal shadow records when required.
• Technical review of Quality Control records (COA, Analytical Testing, Method Validation, Stability reports).
• Operational oversight of CMOs per quality agreements (may include periodic visits).
• Serve as Person in Plant (PIP) when critical processing occurs.
• Support Pre-Approval Inspection readiness for NDA/commercial launch.
• Review sections of New Drug Applications for content and accuracy.
• Review Quality Agreements and support supplier audits.
• Interact with Qualified Persons (QP) to facilitate release of Clinical and Commercial product.
• Generate metrics for Quality Management Reviews; contribute to Annual Product Quality Reviews.
• Represent GMP Quality during internal and regulatory inspections.
• Author Quality department SOPs as required.

Education

Bachelor's degree

MS/PharmD/PhD

Tools

Quality Management Systems (Veeva/TrackWise)

Microsoft Office (Word/Excel/PowerPoint/SharePoint)

Quality Systems & regulatory filings

Job description

Associate Director, GMP Quality

• Batch disposition/release for Clinical Trial Materials and Commercial batches
• Technical review, quality oversight, and approvals of Master Batch records and Executed Batch records
• Review/approve CMO deviations, CAPA, and Change Controls; open internal shadow records when required
• Technical review of Quality Control records (e.g., Certificate of Analysis, Analytical Testing, Method Validation, Stability reports)
• Operational oversight of CMOs per quality agreements (may include periodic CMO visits)
• Serve as Person in Plant (PIP) when critical processing occurs
• Support Pre-Approval Inspection readiness for NDA/commercial launch
• Review sections of New Drug Applications for content and accuracy
• Review Quality Agreements and support supplier audits
• Interact with Qualified Persons (QP) to facilitate release of Clinical and Commercial product
• Generate metrics for Quality Management Reviews; contribute to Annual Product Quality Reviews
• Represent GMP Quality during internal and regulatory inspections
• Author Quality department SOPs as required

Qualifications / Key requirements:

• Bachelor's degree required; MS/PharmD/PhD preferred
• Extensive understanding of industry standards and current cGMP (21 CFR Parts 210/211), EudraLex Vol. 4, ICH Q7 and related GMP Quality Assurance guidance
• Minimum 8 years in an FDA-regulated Pharmaceutical GMP/GMP QA role
• Experience with small molecule synthesis and analytical test record review
• Prior NDA/BLA submission and commercial launch experience
• Familiarity with Quality Systems and robust investigations; Health Authority filings and EU QP queries
• Experience managing CMO relationships and supporting CMO inspections
• Experience with Quality Management Systems (e.g., Veeva or TrackWise)
• Proficient in Word, Excel, PowerPoint, SharePoint

Skills/attributes:

• Leadership, communication, adaptability, collaboration
• Clear writing and verbal presentation; ability to prioritize and work independently

Travel: 10-15% (some international)

Compensation/benefits:

• Base pay range: $160,000-$180,000 annually; total compensation includes equity, bonus, and benefits. A Summary of Benefits is available for applicants.