Quality Assurance Manager

Placements24; East End (United States Virgin Islands); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Highly competitive salary with annual/

Health, dental, and vision insurance

Remote work allowance and home office

Retirement fund with matching

Leadership development opportunities

Job summary

Placements24 is seeking an experienced Quality Assurance Manager to lead QA operations remotely in the pharmaceutical sector. The role focuses on developing, implementing, and overseeing QMS, driving continuous improvement, and fostering a strong quality culture across the organization.

The ideal candidate has a master's degree in a scientific discipline and 7+ years in QA, including 2+ years in management, with deep GMP/ICH knowledge and proven CAPA experience.

Qualifications

• Master's degree in Pharmacy, Chemistry, or related scientific discipline.
• 7+ years in Quality Assurance within pharma, with at least 2 years in a managerial role.
• Thorough understanding of GMP, ICH guidelines and regulatory expectations.
• Proven experience in developing and implementing QMS, audits, and CAPA.
• Excellent leadership, communication, and problem-solving skills.
• Ability to effectively manage and motivate a remote team.

Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) compliant with GMP and standards.
• Oversee internal audits and quality reviews to ensure procedures are followed.
• Manage external audits by regulators and customers with successful outcomes.
• Lead and mentor the QA team and drive continuous improvement.
• Investigate deviations, OOS, and complaints; implement CAPA.
• Ensure all products meet quality standards before market release.

Skills

Leadership

Auditing

Regulatory knowledge

Quality mindset

Remote team management

Problem solving

Communication

Education

Master's degree in Pharmacy, Chemistry, or related discipline

Tools

QMS software

CAPA systems

Job description

About the Role

Our client is looking for an experienced and strategic Quality Assurance Manager to lead their QA operations, working remotely. This role is crucial for maintaining the highest standards of quality across all pharmaceutical products and processes, ensuring compliance with national and international regulations. You will be responsible for developing, implementing, and overseeing quality management systems, driving continuous improvement, and fostering a robust quality culture throughout the organization. This is an ideal opportunity for a leader passionate about quality and compliance in the pharmaceutical sector, who excels in a remote work environment.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with GMP and other relevant standards.
• Oversee and conduct internal audits and quality reviews to ensure adherence to procedures and regulatory requirements.
• Manage external audits by regulatory authorities and customers, ensuring successful outcomes.
• Lead and mentor the QA team, fostering a culture of quality awareness and continuous improvement.
• Investigate deviations, out-of-specifications (OOS), and customer complaints, implementing corrective and preventive actions (CAPA).
• Ensure all pharmaceutical products meet specified quality standards before release to the market.

Requirements

• Master's degree in Pharmacy, Chemistry, or a related scientific discipline.
• Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry, with at least 2 years in a managerial role.
• Thorough understanding of GMP, ICH guidelines, and regulatory expectations for pharmaceutical quality.
• Proven experience in developing and implementing QMS, conducting audits, and managing CAPA systems.
• Excellent leadership, communication, and problem-solving skills.
• Ability to effectively manage and motivate a remote team.

Benefits

• Highly competitive salary with potential for significant annual bonuses.
• Comprehensive benefits package including health, dental, and vision insurance.
• Generous remote work allowance and home office support.
• Retirement fund with matching contributions.
• Opportunities for leadership development and to shape the quality strategy of a growing company.