Director, Quality Assurance – Combination Products

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

📋 Description

• Supervise the quality and regulatory compliance of combination products.

• Create and execute quality strategies and processes tailored for combination products.

• Serve as the QA contact for inquiries and issues related to quality concerning device and combination products.

• Collaborate with teams across product development, manufacturing, clinical development, supply chain, commercial, quality, and regulatory affairs.

• Establish and implement quality standards, specifications, methods, systems, and metrics for both clinical and commercial quality operations.

• Keep track of changes in medical device regulations and combination product standards, as well as industry best practices.

• Engage in the development, review, and approval processes of product documentation, including design control, risk management, and validation.

• Identify gaps and opportunities for improvement within the Design History File and Risk Management, ensuring they are tracked to resolution.

• Oversee the quality and compliance of external partners and suppliers, including validation studies.

• Report quality and compliance status to senior management.

• Prepare for and conduct regulatory audits, ensuring that any observations are addressed promptly.

• Act as the Quality representative on assigned product teams.

• Travel 5–15% domestically and internationally.

⛳️ Requirements

• Bachelor’s degree in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related discipline.

• Over 10 years of experience in quality oversight for drug product device development, demonstrating a successful history of product launches.

• Required experience in quality oversight of design controls and combination products.

• Comprehensive knowledge of 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, and EU MDR.

• Familiarity with the lifecycle management of combination products from the initial design phase to commercialization.

• Experience with quality oversight of biological drug products and working with Contract Manufacturing Organizations (CMOs) is advantageous.

• Exceptional communication and interpersonal skills, both within the organization and with external partners.

• Proficient in identifying and resolving complex issues.

• Ability to operate in alignment with Vera’s Core Values.

🏝️ Benefits

• Annual performance incentive bonus.

• Equity opportunities for new hires.

• Continuous performance-based equity.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401k matching program.

• Flexible time off policy.

• Paid holidays.