Remote Pharmaceutical Quality Assurance Lead

About the Role

Our client, a globally recognized pharmaceutical innovator, is actively seeking a highly experienced and meticulous Remote Pharmaceutical Quality Assurance Lead. This role is a fully remote position, offering the opportunity to contribute significantly to our client's mission from anywhere. You will be responsible for overseeing and managing the quality assurance processes across various pharmaceutical development and manufacturing streams, ensuring adherence to all relevant regulatory standards, including GMP, ICH, and other international guidelines. Your expertise will be crucial in developing, implementing, and maintaining robust quality management systems, conducting internal and external audits, reviewing and approving batch records, and leading continuous improvement initiatives. You will play a key role in ensuring product quality and compliance from raw material sourcing through to finished product release.

The ideal candidate possesses a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life sciences field, with a minimum of 8 years of progressive experience in pharmaceutical quality assurance and quality control. Demonstrated experience in leading QA teams and managing complex quality projects is essential. Strong knowledge of pharmaceutical manufacturing processes, regulatory affairs, and validation principles is required. Excellent analytical, problem‑solving, and decision‑making skills are paramount. You will need to be a self‑starter, highly organized, and possess exceptional communication and interpersonal skills to effectively collaborate with cross‑functional teams, including R&D, manufacturing, regulatory affairs, and external partners, all in a remote setting. This position requires a deep commitment to quality and compliance, with a proactive approach to identifying and mitigating risks. You will be instrumental in driving a culture of quality excellence within the organization.

The successful candidate will be adept at interpreting complex regulations and translating them into actionable QA strategies. Experience with electronic quality management systems (eQMS) and data integrity principles is highly desirable. This is an outstanding opportunity to join a leading pharmaceutical company and make a tangible impact on the quality and safety of life‑saving medications, all while enjoying the benefits of a remote work environment. Your contributions will directly influence patient safety and product integrity.

Responsibilities

• Lead and manage pharmaceutical quality assurance activities.
• Develop, implement, and maintain Quality Management Systems (QMS).
• Ensure compliance with GMP, ICH, and other regulatory guidelines.
• Conduct internal and external audits of facilities and processes.
• Review and approve batch records, deviations, and change controls.
• Oversee validation activities for equipment, processes, and analytical methods.
• Lead investigations of quality deviations and implement corrective and preventive actions (CAPAs).
• Manage product quality reviews and ensure timely release of pharmaceutical products.
• Train and mentor QA team members.
• Collaborate with R&D, manufacturing, and regulatory affairs teams.
• Drive continuous improvement initiatives in quality processes.
• Stay current with evolving pharmaceutical regulations and industry best practices.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or related life science.
• Minimum of 8 years of experience in pharmaceutical quality assurance/control.
• Proven experience in leading QA teams and managing quality projects.
• In‑depth knowledge of GMP, ICH guidelines, and pharmaceutical regulations.
• Strong understanding of pharmaceutical manufacturing processes and validation.
• Excellent analytical, problem‑solving, and decision‑making abilities.
• Exceptional written and verbal communication skills.
• Proficiency in eQMS and data integrity principles.
• Ability to work independently and manage time effectively in a remote setting.
• Strong leadership and interpersonal skills.