CQV Quality Manager – GMP Validation Leader

BioSpace; Irvine (CA); In loco; USD 125.000 - 135.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical benefits

Flexible Spending & HSAs

Life Insurance

Pet Insurance

PTO & Holidays

401K

Descrizione del lavoro

Siegfried Irvine seeks an experienced CQV leader to oversee commissioning, qualification, and validation for drug products, devices and manufacturing processes. You will own the site validation strategy, manage master plans, and supervise qualification activities across facility, utility and equipment systems.

The role requires strong GMP knowledge, cGMP proficiency, and collaboration with PM, Engineering, MS&T, and Operations to support new product introductions and ongoing process

Competenze

• Experience with commissioning, qualification and validation processes.
• Ability to coordinate cross-functional teams and manage stakeholders.
• Knowledge of cGMPs and cleanroom environments.

Mansioni

• Own and manage site validation strategy and QA documentation.
• Oversee qualification activities and approval of protocols.
• Lead sterilization, aseptic, PPQ, cleaning, analytical, and computer system validation.
• Coordinate CQV life cycle for new and existing products.
• Represent CQV in regulatory inspections and client audits.

Conoscenze

CQV knowledge

Validation leadership

GMP compliance

Regulatory inspections

Cross-functional coordination

Technical writing

Formazione

Bachelor's Degree in engineering or science

Descrizione del lavoro

Siegfried Irvine seeks an experienced CQV leader to oversee commissioning, qualification, and validation for drug products, devices and manufacturing processes. You will own the site validation strategy, manage master plans, and supervise qualification activities across facility, utility and equipment systems.

The role requires strong GMP knowledge, cGMP proficiency, and collaboration with PM, Engineering, MS&T, and Operations to support new product introductions and ongoing process