Senior Pharmaceutical Quality Assurance Manager (Remote)

Placements24; Queenstown; A distancia; NZD 180.000 - 240.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Dental and vision coverage

401k with employer match

Generous PTO and remote-first culture

Descripción de la vacante

Placements24 is seeking a Senior Pharmaceutical Quality Assurance Manager to lead global quality systems on a remote-first basis. This strategic role focuses on GMP, ICH, and FDA compliance, shaping a culture of excellence across distributed teams.

You will oversee QMS, audits, CAPA, change control, and supplier quality, while mentoring the QA organization and collaborating with regulatory affairs to ensure inspections readiness and product safety.

Formación

• Master's or PhD in a life science field.
• 10+ years of Pharmaceutical Quality Assurance and Quality Management experience.
• Deep knowledge of GMP (FDA/EMA/SAHPRA) and ICH guidelines.
• Proven experience in establishing QMS, audits, and regulatory inspections.
• Strong leadership for motivating and guiding remote teams.

Responsabilidades

• Develop and maintain comprehensive QMS in line with global regulatory standards.
• Oversee QA operations: batch record review, deviation management, CAPA, and change control.
• Lead internal and external audits, ensuring readiness for regulatory inspections.
• Develop and deliver quality training programs across departments.
• Monitor quality metrics and report on compliance status and areas for improvement.
• Collaborate with regulatory affairs to align quality systems with submission requirements.
• Manage supplier quality agreements and conduct supplier audits.
• Investigate quality issues and perform root cause analysis with CAPA.
• Promote a strong quality culture and provide leadership to the QA team.

Conocimientos

Leadership

Regulatory knowledge

QA management

Analytical thinking

Communication

Problem solving

Educación

Master's or PhD in Pharmacy/ Chemistry/ Biotechnology or related life science

Herramientas

Quality management software

Audit tools

Descripción del empleo

About the Role

Our client, a global leader in pharmaceutical innovation, is actively seeking a highly experienced Senior Pharmaceutical Quality Assurance Manager to join their fully remote team. This is a strategic leadership role focused on establishing and maintaining robust quality systems across the organization. You will be responsible for ensuring compliance with all relevant regulatory requirements, including GMP, ICH, and FDA guidelines, and driving a culture of quality excellence. As a remote-first manager, you will need exceptional leadership, communication, and organizational skills to effectively guide and collaborate with teams dispersed globally. The ideal candidate is a proactive quality professional with a deep understanding of pharmaceutical operations and a passion for ensuring product safety and efficacy. This is an exceptional opportunity to shape the quality landscape of a leading pharmaceutical company from a remote setting.

Key Responsibilities

• Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in alignment with global regulatory standards.
• Oversee and manage all aspects of Quality Assurance operations, including batch record review, deviation management, CAPA implementation, and change control.
• Lead internal and external audits, ensuring readiness for regulatory inspections.
• Develop and deliver quality training programs to personnel across various departments.
• Monitor key quality metrics and performance indicators, reporting on compliance status and areas for improvement.
• Collaborate with regulatory affairs to ensure alignment of quality systems with submission requirements.
• Manage supplier quality agreements and conduct supplier audits.
• Investigate quality issues, root cause analysis, and implement effective corrective and preventive actions.
• Promote a strong quality culture throughout the organization.
• Provide strategic guidance and leadership to the QA team, fostering professional development.

Requirements

• Master's degree or Ph.D. in Pharmacy, Chemistry, Biotechnology, or a related life science discipline.
• Minimum of 10 years of progressive experience in Pharmaceutical Quality Assurance and Quality Management.
• In-depth knowledge of GMP regulations (FDA, EMA, SAHPRA), ICH guidelines, and other relevant quality standards.
• Proven experience in establishing and maintaining QMS, conducting audits, and managing regulatory inspections.
• Strong leadership and team management skills, with the ability to motivate and guide remote teams.
• Excellent analytical, problem-solving, and decision-making abilities.
• Exceptional communication, interpersonal, and negotiation skills.
• Demonstrated ability to manage complex projects and drive continuous improvement initiatives.
• Proficiency in quality management software and tools.
• Experience in risk management methodologies.

Benefits

Our client offers a highly competitive executive-level salary, significant bonus potential, and equity options. This is a fully remote position, offering unparalleled flexibility and work-life integration. Comprehensive health, dental, and vision insurance are provided. A generous paid time off policy, including vacation, sick leave, and holidays, is standard. Opportunities for professional development, including leadership training and attendance at major industry conferences, are readily available. A 401k plan with a substantial employer match is offered. Our client is committed to fostering a high-performance, inclusive, and quality-driven remote work culture.