Hybrid Senior QA Director, Quality Systems & Audits

ARS Pharmaceuticals, Inc.; San Diego (CA); Ibrido; USD 206.000 - 230.000; Tempo pieno

Vantaggi offerti da questo lavoro

Equity

401k matching

100% employer paid Medical, Dental & V

ision for employees

Descrizione del lavoro

ARS Pharmaceuticals, Inc. is seeking a senior QA leader to own the Quality Management System for an outsourced manufacturing model. The role is onsite hybrid in San Diego, and you will lead QA strategy, audits, and regulatory inspection readiness.

You will manage document control, training, supplier qualification, and cross-functional quality initiatives with Manufacturing, Regulatory, Supply Chain, Clinical, and Commercial teams, ensuring data integrity and compliance.

Competenze

• Influences without direct authority across functions.
• Designs quality processes that scale and stay inspection-ready.
• Judges audit findings by risk and assigns appropriate priority.
• Clear audit reports and regulators/leadership communications.
• Willingness to travel up to 25% for audits.

Mansioni

• Lead QA strategy, priorities, and objectives with Head of QA.
• Oversee document control systems and cGMP training.
• Own supplier qualification program and audits of CMOs and labs.
• Lead inspections readiness and serve as QA SME during regulatory inspections.
• Drive cross-functional quality initiatives with Manufacturing, Regulatory, Supply Chain, Clinical, and Commercial teams.

Conoscenze

Influence

Systems thinking

Audit judgment

Communication

Travel 25%

Formazione

Bachelor's in science/engineering

Descrizione del lavoro

ARS Pharmaceuticals, Inc. is seeking a senior QA leader to own the Quality Management System for an outsourced manufacturing model. The role is onsite hybrid in San Diego, and you will lead QA strategy, audits, and regulatory inspection readiness.

You will manage document control, training, supplier qualification, and cross-functional quality initiatives with Manufacturing, Regulatory, Supply Chain, Clinical, and Commercial teams, ensuring data integrity and compliance.