Head of Quality (Pharmaceutical)

Confidential Jobs; Singapore; On-site; SGD 120,000 - 160,000; Full time

Job summary

A pharmaceutical startup in Singapore is seeking a Head of Quality to oversee QA and QC activities, ensuring compliance with regulatory standards. The role requires a strategic leader with at least 10 years of experience in pharmaceutical QA/QC and extensive knowledge of cGMP and relevant regulations. The ideal candidate will be responsible for driving continuous improvement and team leadership.

Qualifications

• Minimum 10 years in pharmaceutical QA/QC, including 5+ in senior leadership.
• Extensive knowledge of cGMP, GLP, GCP, ICH Q7/Q8/Q9/Q10, and international regulatory requirements.
• History of successful regulatory inspections (e.g., FDA, EMA, HSA), audit leadership, and operational excellence.

Responsibilities

• Establish, implement, and maintain robust quality management systems (QMS) aligned with cGMP, GLP, and ICH guidelines.
• Lead all QA programs, including batch record review and risk management.
• Oversee all QC operations, ensuring timely and accurate testing of products.
• Lead, mentor, and motivate QA and QC teams; set clear objectives.
• Set, monitor, and report on key quality KPIs; drive process improvements.

Skills

Expert understanding of pharmaceutical regulations

Strong leadership

Organizational skills

Team development

Communication skills

Analytical and solution-oriented

Attention to detail

Skilled in process improvement

Problem-solving

Risk management

Education

Bachelor's or Master's in Pharmacy, Chemistry, Life Sciences, or related field

Job description

About the Role

The Head of Quality oversees and directs all QA and QC activities to ensure that pharmaceutical products are developed, manufactured, and released according to stringent regulatory standards. The position is accountable for strategic leadership, regulatory compliance, GMP adherence, and continuous improvement, ensuring patient safety and product efficacy throughout the lifecycle. This is a greenfield pharmaceutical startup.

Responsibilities

Strategic and Regulatory Leadership

• Establish, implement, and maintain robust quality management systems (QMS) aligned with cGMP, GLP, ICH guidelines, and other applicable standards (FDA, EMA, PIC/S, & HSA).
• Set and communicate a clear quality strategy; ensure widespread understanding across the organization.
• Serve as lead company representative during regulatory and certification audits/inspections, including FDA, EMA, MHRA, and local authorities.
• Oversee quality system documentation, including SOPs, protocols, batch records, validation, and change control.

Quality Assurance (QA)

• Lead all QA programs, including batch record review, final product release, CAPA, deviations, and risk management.
• Continuously monitor compliance with GMP and quality regulations across facilities, personnel, and processes.
• Conduct internal and supplier audits; ensure readiness for any external inspection.
• Guide root cause analyses, continuous improvement efforts, and remediation plans in the event of non-conformities.

Quality Control (QC)

• Oversee all QC operations, ensuring testing of raw materials, in-process samples, finished products, process validation, and environmental monitoring is timely and accurate.
• Approve QC policies, test methods, and specifications ensuring validity and compliance.
• Ensure appropriate investigation and resolution of OOS (out of specification) and OOT (out of trend) results.
• Ensure all testing and reporting meet regulatory and company requirements for data integrity.

Team Leadership & Training

• Lead, mentor, and motivate QA and QC teams; set clear objectives, conduct appraisals, and deliver ongoing training.
• Develop a culture of accountability, quality, and operational excellence.
• Oversee training programs to ensure compliance with current GMP, SOPs, and regulatory expectations.

Continuous Improvement and Reporting

• Set, monitor, and report on key quality KPIs—CAPA effectiveness, audit outcomes, compliance rates, batch release turnaround, documentation compliance, and training completion.
• Drive process improvements through risk assessments and proactive change management.

Qualifications

• Bachelor’s or Master’s in Pharmacy, Chemistry, Life Sciences, or related field.
• Minimum 10 years in pharmaceutical QA/QC, including 5+ in senior leadership.
• Extensive knowledge of cGMP, GLP, GCP, ICH Q7/Q8/Q9/Q10, and international regulatory requirements.
• History of successful regulatory inspections (e.g., FDA, EMA, HSA), audit leadership, and operational excellence.

Required Skills

• Expert understanding of pharmaceutical regulations, QMS, and data integrity.
• Strong leadership, organizational, team development, and communication skills.
• Analytical, decisive, and solution-oriented with attention to detail.
• Skilled in process improvement, problem-solving, risk management, and change control.