SENIOR QUALITY ASSURANCE (QA) LEAD

Located in Thousand Oaks, California, 20BLOC is a small privately held development-stage biopharmaceutical company, driven by a mission to create breakthrough protein-based drugs to save lives. Our lead product is an innovative solution to provide oxygen to tissues. Check us out at

We are looking for a motivated and hands-on Senior QA Lead to join our team.

How you will add value to 20BLOC

The Senior QA Lead will lead all aspects of Quality Compliance in the organizations, including the Vendor Qualification, External & Internal Auditing, Inspection Management, and Management Review programs. Additionally, the role will lead all aspects of Quality Management Systems (QMS) including the Documentation, Training, Events, CAPA, and Change Control programs, to ensure compliance with applicable GxP and regulatory requirements.

The Senior QA Lead serves as the Quality authority within the organization, providing strategic direction while remaining hands-on in daily quality operations, and works closely with Manufacturing, Analytical Development, Regulatory Affairs, Supply Chain, Facilities, and Clinical to support business objectives and ensure product quality and patient safety.

Key Responsibilities

Serve as the Quality lead and subject matter expert for all GxP-related activities, including GMP and GCP

Establish, maintain, and continuously improve the Quality Management System (QMS)

Ensure compliance with applicable regulations (e.g., FDA, EMA, ICH, local health authorities)

Act as the company’s authorized quality representative for regulatory inspections and audits

Lead and manage quality processes including:

Quality Events, including Deviations, CAPAs, complaints, change control, and risk management

Document control and record management

Training and qualification programs

Supplier qualification and oversight

Clinical Quality oversight

Oversee and perform batch record review, product disposition, and release activities

Ensure validation and qualification activities are planned and executed appropriately

Support regulatory submissions and responses to regulatory authorities

Lead internal audits and manage external audits (regulatory, customer, supplier)

Partner with cross-functional teams to drive quality culture and continuous improvement

Build, mentor, and develop quality staff as the organization grows

Provide quality metrics, reports, and recommendations to senior management

Education

Bachelor degree in Life Sciences or a related field

Advanced degree (Master or PhD) preferred

Experience

Minimum of 8–10 years of experience in pharmaceutical quality (QA/QC), including GMP environments

Prior experience in a quality leadership role, preferably in a small or mid-sized pharmaceutical company

Direct experience interacting with regulatory authorities during inspections

Skills & Competencies

Strong knowledge of GMP, GxP, ICH guidelines, and pharmaceutical quality systems

Skills & Competencies

Strong leadership with a hands-on approach

Excellent understanding of quality systems and regulatory compliance

Ability to work effectively in a fast-paced, resource-limited environment

Strong problem-solving, risk assessment, and decision-making skills

Excellent written and verbal communication skills

Ability to influence cross-functional teams and senior stakeholders

High attention to detail with a strong commitment to patient safety and product quality

Please apply at – in subject line: Senior QA Lead

This is a full-time, on-site position located in Thousand Oaks, CA, and requires working on-site Monday through Friday. All applicants much be authorized to work in the United States. We are not sponsoring employment visas.

Compensation: The salary range for this position is $120,000.00. to $150,000.00 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.

20BLOC is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or other applicable legally protected characteristics. We offer competitive compensation and benefits including health, dental, vision and life insurance, 401(k) and paid time off.