Remote Senior Manager, Quality Systems & CAPA Excellence

Bayside Solutions; California (MO); On-site; USD 150,000 - 185,000; Full time

Job summary

Bayside Solutions is seeking a Senior Manager to lead Quality Management Systems (QMS) across the organization. The role focuses on Quality Events, training, and continuous improvement to ensure mature, inspection-ready QMS practices.

You will coach teams, oversee CAPA lifecycle, and partner with cross-functional stakeholders to strengthen QMS execution. A strong background in GMP, data integrity, and eQMS like Veeva is required.

Qualifications

• Bachelor's degree in a scientific, technical, engineering, pharmacy, or related discipline.
• Minimum of 10 years of pharmaceutical/biotech QA or Quality Systems experience.
• Strong experience with Quality Events, deviations, investigations, CAPAs, and temp excursions.
• Experience training teams on Quality Event processes and documentation.
• Knowledge of GMP, Quality Risk Management, data integrity and inspection readiness.

Responsibilities

• Lead training and coaching on Quality Events, QMS processes, and regulatory expectations.
• Improve QMS procedures, processes, tools, and training materials for clarity and compliance.
• Provide SME review and approval for Quality Events and deviations.
• Oversee investigations of product complaints and temperature excursions.
• Guide CAPA development, implementation, and effectiveness assessments.
• Drive audit and inspection readiness with complete, accurate documentation.

Skills

Quality Events

CAPA management

QMS procedures

GMP compliance

Data integrity

Audit readiness

eQMS workflows

Veeva Quality Vault

Education

Bachelor's degree in science/engineering/pharmacy

Advanced degree or QA certification preferred

Tools

Veeva Quality Vault

eQMS tools

Job description

Bayside Solutions is seeking a Senior Manager to lead Quality Management Systems (QMS) across the organization. The role focuses on Quality Events, training, and continuous improvement to ensure mature, inspection-ready QMS practices.

You will coach teams, oversee CAPA lifecycle, and partner with cross-functional stakeholders to strengthen QMS execution. A strong background in GMP, data integrity, and eQMS like Veeva is required.