Remote Pharmaceutical Quality Assurance Manager

Placements24; Bellville; Hybrid; ZAR 1,200,000 - 1,600,000; Full time

Benefits offered by this job

Remote work setup support

Health, dental, and vision insurance

Retirement savings plan

Learning & certification opportunities

Wellness allowance

Job summary

Placements24 invites a highly experienced Pharmaceutical Quality Assurance Manager to join our client’s remote team. You will lead QA strategy across pharmaceutical product lines, ensuring compliance with GMP, GDP, and international guidelines while enabling patient safety from a home office.

The ideal candidate has 7+ years in pharmaceutical QA, a strong track record in audits, CAPA, and quality management systems, and the ability to influence stakeholders remotely.

Qualifications

• Master's degree or PhD in a scientific field relevant to pharmaceuticals.
• Proven track record in pharmaceutical QA leadership and compliance.

Responsibilities

• Develop, implement, and maintain QA policies, procedures, and systems in line with regulatory requirements.
• Conduct internal and external audits of manufacturing sites, suppliers, and CMOs.
• Review and approve batch records, validation documents, and change controls.
• Manage deviation investigations, root cause analyses, and CAPA implementations.
• Oversee qualification and validation of equipment, processes, and analytical methods.
• Collaborate with regulatory affairs to ensure submissions meet quality standards.
• Train and mentor QA team members on quality systems and compliance.
• Stay updated on evolving regulatory requirements and industry best practices.
• Lead regulatory inspections and client audits.
• Manage supplier qualification program and monitor supplier performance.

Skills

QA leadership

GMP compliance

Auditing

CAPA management

Regulatory knowledge

Root cause analysis

Quality systems

Data analysis

Stakeholder communication

Remote work

Education

Master's degree in Pharmacy

PhD in related field

Job description

About the Role

Our client, a global leader in pharmaceutical manufacturing and innovation, is actively seeking a highly experienced and meticulous Pharmaceutical Quality Assurance Manager to join their expanding team. This is a fully remote position, offering the opportunity to contribute significantly to our quality management systems from the comfort of your home office. You will be responsible for overseeing and implementing quality assurance strategies across various pharmaceutical product lines, ensuring compliance with all relevant regulatory standards, including GMP, GDP, and other international guidelines. The ideal candidate will possess a deep understanding of pharmaceutical quality systems and a proven ability to drive continuous improvement in manufacturing and operational processes. This role is critical in maintaining the highest standards of product quality and patient safety. We are a remote-first company, committed to providing our employees with the tools and support needed to succeed.

Key Responsibilities

• Develop, implement, and maintain robust quality assurance policies, procedures, and systems in line with pharmaceutical industry regulations.
• Conduct internal and external audits of manufacturing sites, suppliers, and contract manufacturers to ensure compliance and identify areas for improvement.
• Review and approve batch records, validation documents, and change controls.
• Manage deviation investigations, root cause analyses, and CAPA implementation.
• Oversee the qualification and validation of equipment, processes, and analytical methods.
• Collaborate with regulatory affairs to ensure submissions and approvals meet quality standards.
• Train and mentor QA team members and other personnel on quality systems and compliance requirements.
• Stay abreast of evolving regulatory requirements and industry best practices, ensuring proactive adaptation of quality systems.
• Lead and participate in regulatory inspections and client audits.
• Manage the supplier qualification program and monitor supplier performance.

Requirements

• Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 7 years of progressive experience in pharmaceutical quality assurance, with a strong emphasis on GMP and regulatory compliance.
• Demonstrated expertise in developing and implementing comprehensive quality management systems.
• Extensive experience with conducting and leading audits (internal and external).
• Proficiency in deviation management, root cause analysis, and CAPA implementation.
• Strong understanding of pharmaceutical manufacturing processes, validation, and stability testing.
• Familiarity with regulatory guidelines from agencies such as FDA, EMA, and local South African authorities.
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional written and verbal communication skills, with the ability to influence stakeholders at all levels.
• Proven ability to manage multiple projects and prioritize tasks effectively in a remote setting.
• Self-motivated with a high degree of integrity and accountability.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive remote work setup support, including equipment and stipend.
• Generous health, dental, and vision insurance coverage.
• Paid time off, including vacation, sick leave, and public holidays.
• Retirement savings plan with company contributions.
• Opportunities for continuous learning and professional certifications.
• Flexible working hours to accommodate a remote schedule.
• Annual wellness allowance.