Senior QA Manager

This is a fully remote position, open to applicants in Connecticut, +9 more states.

📋 Description

• Oversee the remediation of critical external mechanical device suppliers as part of program management.

• Lead a team of quality experts who manage external mechanical device suppliers.

• Ensure adherence to scientific, regulatory, and quality standards throughout global operations.

• Collaborate with cross-functional teams in External Supply, Process Development, and Combination Product Quality.

• Drive changes, maintain product quality, and foster a diverse and inclusive workplace.

• Monitor the quality systems and performance metrics of external device suppliers.

• Establish and uphold quality requirements.

• Manage supplier quality KPIs and handle risk escalations.

• Develop and manage the assigned team members.

• Spearhead impactful initiatives across various functions.

• Promote a culture of continuous improvement and operational excellence.

⛳️ Requirements

• A Doctorate degree with 2 years of experience, OR a Master’s degree with 4 years of experience, OR a Bachelor’s degree with 6 years of experience, OR an Associate’s degree with 10 years of experience, OR a High school diploma/GED with 12 years of experience.

• A degree in Biology, Engineering, Pharmaceutics, Biotechnology, or Physics is preferred.

• Over 10 years of experience in the Medical Device, pharmaceutical, or biotech industries is preferred.

• In-depth knowledge of quality systems, including batch release, complaints, and risk management.

• Familiarity with global supplier management and device regulations.

• Strong leadership, communication, and problem-solving abilities.

• Experience in managing global teams, especially during periods of change.

• Willingness to travel up to 25%, both domestically and internationally.

• Sponsorship for this position is not guaranteed.

🏝️ Benefits

• A comprehensive benefits package for employees, featuring a Retirement and Savings Plan with generous contributions from the company.

• Coverage for group medical, dental, and vision needs.

• Life and disability insurance options.

• Flexible spending accounts available.

• A discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models wherever feasible.

• Financial plans that provide opportunities for saving towards retirement or other objectives.

• Opportunities for career development.

• Health and welfare plans for staff and eligible dependents.