Remote Pharmaceutical Quality Assurance Manager

Our client, a rapidly expanding pharmaceutical research and development company, is seeking a meticulous and experienced Pharmaceutical Quality Assurance Manager to lead their quality systems from a fully remote capacity. This critical role will ensure that all activities, from drug development to manufacturing oversight, adhere to stringent regulatory standards, including FDA, EMA, and other relevant global health authorities. The ideal candidate possesses a deep understanding of GMP, GCP, and GLP principles and is adept at developing, implementing, and maintaining robust quality assurance programs.

Responsibilities:

• Develop, implement, and manage the company's Quality Management System (QMS) to ensure compliance with pharmaceutical regulations.
• Oversee all aspects of quality assurance, including batch record review, deviation management, CAPA implementation, and change control.
• Conduct internal audits and support external regulatory inspections, acting as a primary point of contact for QA-related inquiries.
• Ensure that all manufacturing processes and product testing meet defined quality standards and specifications.
• Develop and deliver quality training programs for relevant personnel.
• Monitor industry trends and regulatory updates, ensuring the QMS remains current and effective.
• Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure seamless integration of quality processes.
• Manage supplier quality agreements and conduct supplier audits as necessary.
• Lead investigations into quality events and implement corrective and preventive actions.
• Contribute to the continuous improvement of quality processes and systems.
• Maintain all quality-related documentation in an organized and readily auditable state.

Qualifications:

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. Advanced degree (M.S., Ph.D., Pharm.D.) is highly preferred.
• Minimum of 7 years of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry.
• In-depth knowledge of GMP, GCP, and GLP regulations and guidelines.
• Proven experience in developing and implementing QMS, including SOPs, change control, deviation management, and CAPA systems.
• Experience with regulatory inspections (FDA, EMA) and successful audit outcomes.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills, with the ability to clearly articulate complex quality issues.
• Demonstrated ability to lead and manage a team, preferably in a remote setting.
• Proficiency in quality management software and data analysis tools.
• High level of attention to detail and commitment to accuracy.
• Ability to work independently and manage multiple priorities effectively in a remote-first environment.

This is an exceptional opportunity to shape the quality culture of a growing pharmaceutical organization. If you are passionate about ensuring product quality and patient safety, and you excel in a remote work environment, we encourage you to apply.