Remote Director Global Analytical Quality (Small Molecules)

Jobgether; United States; On-site; USD 168,000 - 228,000; Full time

Benefits offered by this job

Medical insurance

401(k) plan

Equity awards

Remote work USA

Bonuses

Job summary

Jobgether, on behalf of a partner company, seeks a Director, Quality Analytical Technical Lead, Small Molecule, based in the United States. Senior leader drives the global analytical lifecycle for commercial products and acts as the accountable global technical lead for analytical strategy across major markets.

The role demands GMP analytical expertise, quality oversight, regulatory submissions, and collaboration with internal/external partners, including audits and inspections.

Qualifications

• GMP QC/analytical leadership for commercial small-molecule products.
• Strong knowledge of validation, stability, and lifecycle management.
• Experience supporting regulatory submissions and health authority interactions.

Responsibilities

• Serve as global owner for analytical matters across major markets.
• Provide governance for analytical method lifecycle, validation, and transfers.
• Lead investigations (OOS, OTE, atypical results) and CAPA plans.
• Drive change-control strategies for method updates and revalidations.
• Coordinate with quality, regulatory, and supply chain across partners.
• Support regulatory submissions, inspection readiness, and filings.

Skills

GMP Quality Control

Analytical sciences

HPLC/UPLC

Method validation

Data integrity

Risk-based decision making

Education

Bachelor's degree

Master's degree

Doctoral degree

Tools

Microsoft Office

Job description

Jobgether, on behalf of a partner company, seeks a Director, Quality Analytical Technical Lead, Small Molecule, based in the United States. Senior leader drives the global analytical lifecycle for commercial products and acts as the accountable global technical lead for analytical strategy across major markets.

The role demands GMP analytical expertise, quality oversight, regulatory submissions, and collaboration with internal/external partners, including audits and inspections.