Senior Manager, Quality Systems (QMS)

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

Location:

Redwood City, CA - Remote Role

Job Summary:

The Senior Manager, Quality Management Systems (QMS) will support the ongoing effectiveness, maturity, and inspection readiness of the Quality Management System, with a primary focus on Quality Events, training, and continuous improvement. This role will provide leadership, coaching, and subject matter expertise to ensure Quality processes are consistently understood and effectively executed across the organization.

Duties and Responsibilities:

• Lead training, coaching, and ongoing guidance for team members on Quality Events, QMS processes, systems, and associated regulatory expectations.
• Support continuous improvement of QMS procedures, processes, tools, and training materials to enhance clarity, consistency, compliance, and operational effectiveness.
• Provide subject matter expertise and backup review and approval for Quality Events, including deviations and other assigned records.
• Support product complaint and temperature excursion investigations, ensuring appropriate investigation, documentation, escalation, and timely resolution.
• Provide oversight and guidance for CAPA development, implementation, and effectiveness assessments to ensure actions appropriately address identified risks and root causes.
• Drive ongoing audit and inspection readiness for Quality Events by promoting complete, accurate, timely, and inspection-ready documentation.
• Support Quality Event governance, metrics, trending, and identification of systemic issues and opportunities for improvement.
• Partner cross-functionally with Quality, Manufacturing, Supply Chain, Regulatory, Safety, and other stakeholders to resolve quality issues and strengthen QMS execution.
• Promote a strong quality culture through practical guidance, proactive problem solving, and continuous improvement.

Requirements and Qualifications:

• Bachelor's degree in a scientific, technical, engineering, pharmacy, or related discipline; equivalent relevant experience may be considered.
• Minimum of 10 years of pharmaceutical or biotechnology Quality Assurance or Quality Systems experience.
• Strong experience with Quality Events, including deviations, investigations, CAPAs, effectiveness checks, product complaints, and temperature excursions.
• Demonstrated ability to train and coach team members on Quality Event processes, systems, investigation practices, and documentation expectations.
• Experience supporting QMS procedures, process improvements, and associated training materials.
• Strong knowledge of GMP requirements, Quality Risk Management, data integrity, and inspection-readiness expectations.
• Experience with eQMS workflows, audits, and inspections, Quality metrics, and continuous improvement.
• Strong communication, collaboration, and influencing skills with the ability to work independently and effectively across functions.

Preferred Qualifications:

• Advanced degree or relevant professional Quality certification preferred.
• Experience with Veeva Quality Vault or a comparable eQMS.
• Commercial-stage pharmaceutical or biotechnology experience.
• Experience in small-molecule pharmaceuticals, oncology, or a growing organization preferred.

Desired Skills and Experience

Quality Management Systems (QMS), Quality Assurance, quality events, deviations, investigations, root cause analysis, CAPA management, CAPA effectiveness checks, product complaints, temperature excursions, GMP compliance, Quality Risk Management, data integrity, audit readiness, inspection readiness, eQMS workflows, Veeva Quality Vault, quality governance, quality metrics and trending, systemic issue identification, continuous improvement, SOP and procedure improvement, training material development, employee training and coaching, regulatory compliance, inspection-ready documentation, commercial-stage pharmaceuticals, biotechnology, small-molecule pharmaceuticals, oncology, cross-functional collaboration, leadership, stakeholder influence, problem-solving

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.