Sr. Director, Quality Assurance for Quality Control

Overview

This is a senior QA leadership opportunity in a biotechnology setting, focused on quality control support for vaccine development and related analytical programs. The role is centered on ensuring strong product quality, regulatory adherence, and effective coordination across internal teams and external partners.

The position is posted on behalf of a partner organization, which will handle all applications and subsequent hiring steps. The role is based in the United States and is fully remote.

You will combine technical quality expertise with operational leadership to guide analytical strategies, reinforce GMP compliance, manage quality systems, and support a culture of continuous improvement. The job is well suited to an experienced quality leader who enjoys building strong teams and contributing to innovative healthcare programs with global reach.

Key Responsibilities

• Direct QA oversight for quality control work tied to analytical methods, validation, qualification, release testing, and in-process testing for drug substances and vaccine-related materials.
• Act as a primary quality contact for internal teams and outside partners such as contract manufacturers and testing laboratories.
• Evaluate and approve GMP records and technical documentation, including specifications, certificates of analysis, validation reports, deviations, change controls, risk assessments, CAPAs, and analytical data sets.
• Advise on reference standards, analytical procedures, protocols, and laboratory workflows to keep work aligned with applicable regulations.
• Work with QC, vendor management, and external labs to define performance measures and improve efficiency.
• Lead the resolution of quality events, including testing deviations, out-of-specification findings, and other compliance concerns.
• Review quality agreements and contribute to regulatory filing activities, including submissions and responses to health authority questions.
• Support audit readiness and help maintain inspection preparedness across analytical programs.
• Strengthen GMP policies, procedures, and working practices to improve compliance across the organization.
• Promote a quality-focused, accountable, and improvement-driven culture across internal and external teams.
• Lead and mentor distributed QA teams while maintaining consistent standards across locations.

Requirements

• Bachelor’s degree in Biochemistry, Chemistry, Life Sciences, or a related discipline, along with 15+ years of relevant industry experience.
• Strong working knowledge of FDA, EU, and ICH requirements, plus pharmacopeial expectations related to analytical method qualification and validation.
• Demonstrated ability to translate regulations into practical analytical quality strategies.
• Hands-on experience with biochemical, immunoassay, or microbiological testing in a Quality Control setting.
• Background in analytical validation, method transfer, and qualification work.
• Proven success in building and leading high-performing QA teams in fast-moving biotechnology environments.
• Experience managing teams across multiple sites or countries and standardizing GMP practices globally.
• Strong project management capability with the ability to juggle complex priorities and timelines.
• Excellent communication skills, both written and spoken, with the confidence to influence senior leaders and cross-functional partners.
• Working knowledge of quality risk management and continuous improvement methods.
• Ability to understand and interpret complex scientific and operational information across drug and vaccine development programs.
• Experience collaborating with contract manufacturing organizations and external testing partners worldwide.
• Prior involvement with BLA submissions and commercial launch support is a strong plus.

Benefits and Additional Information

• Compensation is listed at $229,000 to $268,000, depending on location and experience.
• An equity component is included in the total compensation package.
• A comprehensive benefits package is offered to support employee health and well-being.
• The role is fully remote, with flexibility based on business needs.
• This is a chance to help shape quality strategy and operational excellence in a high-impact healthcare environment.
• You will work with scientific, technical, and business stakeholders across disciplines.
• The position offers substantial influence over quality culture and scalable systems in a growing organization.

Hiring Process and Data Notice

Applications are managed by the partner company, which also handles the next steps in the selection process.

The hiring process may involve AI-assisted screening to review applications, analyze resumes, and compare responses with the role’s requirements. These tools support the recruitment team but do not replace human judgment, and final hiring decisions are made by people.

By applying, candidates acknowledge that their personal data may be processed for candidacy evaluation and shared with the hiring employer under applicable data protection rules, including GDPR where relevant. Applicants may exercise rights such as access, correction, deletion, and objection, and can request more information about data handling.