Manager, Quality Operations, CMC

Scorpion Therapeutics; Boston (MA); On-site; USD 117,000 - 137,000; Full time

Job summary

Scorpion Therapeutics in Boston seeks a Product Quality leader to provide end-to-end quality oversight for clinical and commercial programs, including drug substance, drug product, reference standards, packaging, labeling, serialization, and contract service providers.

You will review and approve critical documentation, lead deviations and CAPAs, and oversee contract manufacturers, laboratories, and other providers to ensure release decisions meet regulatory expectations and product quality

Qualifications

• BA/BS in Chemistry, Pharmaceutical Sciences, Engineering, Biology, or related field.
• 6+ years in a GMP-regulated environment supporting clinical and/or commercial pharmaceutical products.
• Strong GMP knowledge and FDA/EMA/ICH regulatory expectations; ability to make practical, risk-based decisions.

Responsibilities

• Provide end-to-end Product Quality oversight for clinical and commercial programs, including drug substance, drug product, reference standards, packaging, labeling, serialization, and contract service providers.
• Review and approve critical product and process documentation (specifications, batch records, technical transfer documents, validation protocols/reports, stability documentation, quality agreements).
• Lead assessment and resolution of deviations, OOS/OOT, atypical results, temperature excursions, change controls, CAPAs, and product quality complaints.
• Provide Quality oversight of contract manufacturers, laboratories, and other service providers (vendor qualification, audits, performance monitoring, manufacturing record review, issue resolution).
• Lead or support product disposition for clinical and commercial batches (release/reject decisions; coordinate with Qualified Persons).
• Represent Product Quality on CMC/program/external partner teams; provide input into development, control strategy, process validation, regulatory submissions, and commercialization.

Skills

Quality oversight

Risk-based decisions

GMP knowledge

Regulatory compliance

Vendor management

Cross-functional collaboration

Education

Bachelor's degree in Chemistry/Pharmaceutical Sciences/Engineering/Biology

Tools

QMS

CAPA tracking

Job description

Primary Responsibilities:

• Provide end-to-end Product Quality oversight for assigned clinical and commercial programs, including drug substance, drug product, reference standards, packaging, labeling, serialization, and associated contract service providers.
• Review and approve critical product and process documentation (specifications, batch records, technical transfer documents, validation protocols/reports, stability documentation, quality agreements).
• Lead assessment and resolution of deviations, OOS/OOT, atypical results, temperature excursions, change controls, CAPAs, and product quality complaints using sound, timely, risk-based decisions.
• Provide Quality oversight of contract manufacturers, laboratories, and other service providers (vendor qualification, audits, performance monitoring, manufacturing record review, issue resolution, follow-up of observations/commitments).
• Lead or support product disposition for clinical and commercial batches (release/reject decisions; coordinate with Qualified Persons where applicable).
• Represent Product Quality on CMC/program/external partner teams; provide strategic input into development, control strategy, technology transfer, process validation, stability, regulatory submissions, and commercialization.
• Partner with CMC, Regulatory Affairs, Supply Chain, and external organizations to anticipate/address quality risks and support IND/NDA filings and regulatory inspections.

Qualifications (Required):

• BA/BS in Chemistry, Pharmaceutical Sciences, Engineering, Biology, or related scientific discipline.
• 6+ years in a GMP-regulated environment supporting clinical and/or commercial pharmaceutical products.
• Strong GMP knowledge and FDA/EMA/ICH and global regulatory expectations; ability to make practical, risk-based decisions.

Preferred/Key Success Factors:

• Experience with small-molecule drug substance and solid oral drug product manufacturing (QMS, QC, technical transfer, validation, stability, lifecycle).
• Hands-on batch disposition, deviations/investigations, change control, CAPA, OOS/OOT, product complaints; Qualified Persons interfacing preferred.
• Inspection/audit experience (health authority, internal, and/or supplier audits).
• Travel ~15–20% domestic/international.

Annualized Base Salary

$117,000–$137,000 USD