Senior Director, Quality Control

This is a fully remote position, open to applicants in California.

📋 Description

• Develop and implement a comprehensive global quality strategy that aligns with corporate goals, regulatory requirements, and risk-based methodologies for product development and commercialization.

• Create and manage the quality strategy throughout the entire product lifecycle (from clinical trials to commercial launch), ensuring operational excellence, appropriate quality systems for each phase, and adherence to regulatory standards.

• Act as the Quality representative in strategic discussions and business planning sessions involving Technical Operations, Regulatory Affairs, and the Executive Leadership Team (ELT).

• Function as a quality subject matter expert (SME) for manufacturing initiatives, chemistry, manufacturing, and controls (CMC) strategies, and regulatory submissions (e.g., IND, BLA, supplements).

• Oversee quality contributions for Quality Target Product Profiles (QTPP), Critical Quality Attribute (CQA) assessments, control strategies, stability programs, and product specifications.

⛳️ Requirements

• A bachelor's or master’s degree in a life sciences field (e.g., Biology, Chemistry, Engineering).

• A minimum of 10 years of experience in biopharmaceutical Quality positions, with at least 5 years in senior leadership roles.

• Significant experience in Good Practices (GxP), biologics manufacturing, late-stage development, and activities that support Biologics License Applications (BLA).

• Strong regulatory expertise, including the ability to author and review submissions and represent the company during global inspections.

• Proficient in product quality systems, including CAPA, deviations, change control, batch release, and comparability assessments.

• Proven success in working within matrixed organizations.

• High emotional intelligence (EQ) and a strong professional demeanor.

• Willingness to travel up to 20% (domestic and international).

🏝️ Benefits

• Health coverage (Medical, Dental, Vision) – PPO & HDHP – provided by Cigna/Principal.

• Health Spending Accounts - HSA (with Annual Company Contribution), FSA, FSA-DC.

• Illness & Disability Protection – Company Paid Long-Term Disability (LTD) Coverage plus optional plans.

• Life Insurance – Company Paid coverage of 1 x base salary plus optional plans.

• 401K plan with a 100% company Safe Harbor match up to 4% of base salary.

• Unlimited Flexible Time Off.

• Holiday observance – In 2026, we will recognize 14 holidays.

• Additional exclusive benefits – Voluntary Legal, Pet Insurance, and more.