Remote Lead Pharmaceutical Quality Assurance Manager

Our client, a renowned global pharmaceutical company, is seeking an experienced and highly motivated Lead Pharmaceutical Quality Assurance Manager to join their fully remote, high-achieving team. This critical leadership role is responsible for overseeing and directing all quality assurance activities within the pharmaceutical division, ensuring compliance with rigorous regulatory standards (FDA, EMA, etc.) and internal quality policies. You will lead a team of QA professionals, drive continuous improvement initiatives, and play a pivotal role in maintaining the highest standards of product quality, safety, and efficacy throughout the drug development and manufacturing lifecycle. The ideal candidate possesses extensive expertise in pharmaceutical quality systems, regulatory compliance, and strong leadership capabilities.

Key Responsibilities:

• Establish, implement, and maintain a robust Quality Management System (QMS) in compliance with global pharmaceutical regulations (cGMP, ICH guidelines).
• Lead, mentor, and develop a team of Quality Assurance professionals, fostering a culture of quality and compliance.
• Oversee all QA operations, including batch record review and release, deviation management, CAPA implementation, change control, and internal/external audits.
• Ensure that all pharmaceutical products meet stringent quality specifications and regulatory requirements before release to the market.
• Develop and conduct comprehensive training programs for QA staff and other relevant departments on quality standards and regulatory expectations.
• Act as the primary point of contact for regulatory agencies during inspections and audits, facilitating a smooth and compliant process.
• Manage and conduct supplier quality audits and evaluations to ensure the quality of raw materials and services.
• Drive continuous improvement initiatives by analyzing quality data, identifying trends, and implementing corrective and preventive actions (CAPAs).
• Review and approve critical quality documents, including validation protocols/reports, SOPs, and manufacturing procedures.
• Stay current with evolving pharmaceutical regulations, industry best practices, and emerging quality technologies.

Qualifications:

• Master's or Ph.D. degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
• Minimum of 10 years of progressive experience in Pharmaceutical Quality Assurance and Quality Control, with at least 5 years in a management or leadership capacity.
• In-depth knowledge and practical application of cGMP regulations (FDA 21 CFR Parts 210/211, ICH Q7, etc.).
• Proven experience in developing, implementing, and managing comprehensive Quality Management Systems.
• Demonstrated experience in leading and managing successful regulatory inspections (e.g., FDA, EMA).
• Strong leadership, team-building, and interpersonal skills, with the ability to inspire and motivate teams in a remote environment.
• Excellent analytical, problem-solving, and decision-making abilities.
• Exceptional written and verbal communication skills, including proficiency in technical report writing and presentation.
• Experience with validation processes (process, cleaning, analytical method) is essential.
• Familiarity with various pharmaceutical manufacturing processes is highly desirable.

This fully remote position offers a highly competitive salary, excellent benefits, and the chance to lead critical quality functions for a leading pharmaceutical company, impacting global health from anywhere.