Sub-Section Head Quality Assurance

Our client, a significant entity in the pharmaceutical landscape, is actively seeking a dedicated Quality Assurance Specialist to join their operations. This is a fully remote position, offering unparalleled flexibility to qualified professionals. The role is pivotal in ensuring that all manufacturing processes, documentation, and products meet stringent quality standards and regulatory requirements. As a remote-first organization, our client is committed to empowering its employees with the autonomy and resources needed to excel in their roles from any location.

You will be integral to maintaining the integrity and compliance of our pharmaceutical products, contributing to patient safety and trust. This opportunity is ideal for meticulous individuals who thrive in independent work environments and possess a keen eye for detail. Your expertise will be crucial in upholding the high standards our client is known for, ensuring seamless operations and continuous improvement in quality management systems across the board.

The remote setup allows for a global talent pool and fosters a culture of trust and accountability.

• Develop, implement, and maintain quality assurance procedures and protocols.
• Conduct internal audits of manufacturing processes, documentation, and systems to ensure compliance with GMP, ISO, and other relevant standards.
• Review and approve batch records, validation reports, and other critical quality documents.
• Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Participate in external audits and regulatory inspections, acting as a key point of contact.
• Monitor and analyze quality control data, identifying trends and areas for improvement.
• Ensure that all activities comply with FDA regulations, ICH guidelines, and company SOPs.
• Train personnel on quality assurance procedures and best practices.
• Manage supplier quality agreements and conduct supplier audits as needed.
• Contribute to the continuous improvement of the Quality Management System (QMS).

• Bachelor's degree in Chemistry, Biology, Pharmacy, or a related scientific field.
• Minimum of 3 years of experience in Quality Assurance within the pharmaceutical or medical device industry.
• Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements (e.g., FDA 21 CFR Part 210/211).
• Experience with auditing, deviation investigations, and CAPA management.
• Proficiency in quality management software and tools.
• Excellent written and verbal communication skills, with the ability to document findings clearly and concisely.
• Strong analytical and problem-solving abilities.
• Proven ability to work independently and manage multiple priorities in a remote setting.
• Detail-oriented with a high level of accuracy.
• Familiarity with validation processes (e.g., process validation, cleaning validation) is a plus.

Our client is pleased to offer a comprehensive package for this remote role, including a competitive annual salary, performance-based bonuses, and potential for equity participation. Employees receive excellent health coverage, encompassing medical, dental, and vision insurance, along with life and disability insurance. A robust retirement savings plan is provided with a company match. Generous paid time off, including vacation days, personal days, and holidays, is standard.

We invest in our employees’ growth through continuous learning opportunities, such as access to online courses, workshops, and industry conferences. A dedicated home office stipend is provided to ensure a productive remote work environment. Additionally, employee assistance programs are available for comprehensive support.