QMS Investigations Manager – CGMP Leader

PCI San Diego, Inc.; San Diego (CA); Presencial; USD 107.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Paid time off

Health insurance coverage (including)

Flexible spending account

401(k) plan

Descripción de la vacante

PCI Pharma Services is seeking a Manager, QMS Investigations in San Diego to lead the investigations team within CGMP operations. You will direct deviations, change controls, and CAPAs, ensuring timely closure and regulatory compliance, while partnering with Quality, Manufacturing, Microbiology, and Facilities.

The role emphasizes people leadership, employee development, performance management, and building a high-performing team culture aligned with PCI policies.

Formación

• Bachelor's degree in Life Sciences or related field preferred, or equivalent combination of education and/or relevant work experience.
• 9+ years of relevant experience in a CGMP environment, Manufacturing preferred.
• Demonstrated success in performance management, employee development, coaching, and driving team results.
• Must have expert level knowledge in global pharmaceutical CGMP's.

Responsabilidades

• Investigates and resolves deviations, change controls, OOS reports, CAPAs and other CGMP quality system records.
• Directs day-to-day operations of the Investigations team to ensure timely, compliant execution.
• Authors and revises complex documents including compliance, change controls and other technical documentation.
• Leads cross-functional teams and collaborates with clients to resolve investigations and audits.

Conocimientos

Leadership

Documentation

Regulatory compliance

Microsoft Office

Educación

Bachelor's degree in Life Sciences

9+ years CGMP experience

Herramientas

Microsoft Office

Descripción del empleo

PCI Pharma Services is seeking a Manager, QMS Investigations in San Diego to lead the investigations team within CGMP operations. You will direct deviations, change controls, and CAPAs, ensuring timely closure and regulatory compliance, while partnering with Quality, Manufacturing, Microbiology, and Facilities.

The role emphasizes people leadership, employee development, performance management, and building a high-performing team culture aligned with PCI policies.