Senior QA Manager: Biotech GMP & Compliance

Initial Therapeutics, Inc.; Thousand Oaks (CA); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Flexible work models (remote/hybrid)

Total Rewards plan

Stock-based long-term incentives

Comprehensive benefits package

Job summary

Amgen is seeking a QA Manager to oversee daily QA operations, ensuring products meet quality standards across manufacturing, testing, and utilities. You will lead the QA team, drive continuous improvement, and coordinate audits with regulatory agencies.

The role requires advanced degrees with QA leadership experience and a strong track record in regulatory compliance and problem solving, in a fast-paced biotech setting. Flexible work models may be available.

Qualifications

• Doctorate degree or higher
• Masters degree with 3+ QA years
• Bachelors degree with 5 QA years
• Associates degree with 10 QA years
• High school diploma / GED with 12 QA years
• Experience directly managing people or leadership roles in QA

Responsibilities

• Partner with manufacturing, supply chain, facilities and engineering to maintain quality culture and ensure the facility operates safely and compliantly.
• Provide quality oversight of manufacturing operations, testing, inspection and utilities.
• Lead the quality assurance team with a focus on strategic direction, staff development, and high-performance culture.
• Champion quality initiatives and collaborate with cross-functional teams to drive continuous improvement projects.
• Process optimization - assess and optimize quality processes to enhance efficiency and effectiveness.
• Ensure compliance with cGMP practices and regulatory requirements.
• Provide leadership and support during audits and inspections, including interaction with regulatory agencies.
• Develop and manage training programs to ensure team competencies and understanding of cGMP requirements.
• Manage quality-related issues, ensuring corrective actions prevent recurrence.
• Evaluate team performance and coach for career growth and development.
• Participate in quality records oversight for Deviations, Change Controls, and CAPAs.
• Provide quality guidance to operational staff and cross-functional Amgen teams.
• Represent the Quality function during projects to improve manufacturing goals.
• Flexibility to cover different shifts as required by 24/7 production schedule.

Skills

Quality leadership

cGMP knowledge

Audits & inspections

Regulatory compliance

Team development

Education

Doctorate degree

Masters degree + 3 years QA experience

Bachelors degree + 5 years QA experience

Associates degree + 10 years QA experience

High school diploma / GED + 12 years QA experience

Job description

Amgen is seeking a QA Manager to oversee daily QA operations, ensuring products meet quality standards across manufacturing, testing, and utilities. You will lead the QA team, drive continuous improvement, and coordinate audits with regulatory agencies.

The role requires advanced degrees with QA leadership experience and a strong track record in regulatory compliance and problem solving, in a fast-paced biotech setting. Flexible work models may be available.