Director, Quality R&D & GMP Operations

Jobtailor; Upper Merion Township (Montgomery County); On-site; USD 180,000 - 240,000; Full time

Job summary

Jobtailor seeks an accomplished quality leader to head the R&D quality organization, guiding GMP manufacturing, storage and distribution activities for regulatory compliance and product integrity.

The role requires extensive cGMP experience, QMS implementation, and a track record in regulatory readiness, CAPA, change control and risk management across global operations. Leadership and communication are essential to drive improvements and build a robust quality network.

Qualifications

• Master’s degree in Bioengineering or related field.
• Ten or more years of quality experience in a regulated environment.
• Five or more years of experience in cGMP globally and new product introduction.
• Three or more years of experience determining phase appropriate requirements for clinical supply and commercial PAI requirements for commercial.
• Extensive knowledge of cGMPs, FDA guidelines, compliance requirements, facility registration, validation, regulatory submissions and regulatory reporting requirements.
• Strong knowledge and application of the QMS.
• Operational Excellence tools and KPI management.
• Agility to operate in a matrix organisation between R&D & GSC.
• Strong presentation skills - Capability to present in front of a national and international panel.
• Preferred: PhD in bioengineering or related field.
• Strong leadership, interpersonal, decision-making, prioritization, critical thinking, data analysis and problem-solving skills.

Responsibilities

• Lead the quality organization in R&D supporting GMP manufacturing, storage and distribution activities.
• Ensure production of seeds and cell banks, API, drug substances and drug products complies with cGMP/cGDP.
• Implement high-quality processes and QMS supporting cGMP, regulatory expectations and GSK standards.
• Manage quality governance, quality oversight, regulatory observations, deviations, CAPA, change control, written standards, training and management monitoring.
• Manage quality issues, evaluate impact on quality, safety, efficacy and clinical data, and lift with remediation proposals.
• Identify and manage quality and business risks.
• Host quality inspections and audits and ensure inspection readiness.
• Support product and technology transfers to GSK or CMOs.
• Represent Quality R&D positions in meetings and build the GSK quality network.
• Provide direction, build team capability, support career development and lead change initiatives involving processes, products, technologies, digitalization, culture and people.
• Ensure employee safety, preventive measures, skills and medical aptitude, and manage EHS risks and incidents.

Skills

Quality Governance

Regulatory Observations

CAPA Management

Change Control

Data Analysis

Clinical Supply Requirements

Validation

KPI Management

Risk Management

Quality Inspections

Education

Master’s degree in Bioengineering

PhD in Bioengineering (Preferred)

Job description

Jobtailor seeks an accomplished quality leader to head the R&D quality organization, guiding GMP manufacturing, storage and distribution activities for regulatory compliance and product integrity.

The role requires extensive cGMP experience, QMS implementation, and a track record in regulatory readiness, CAPA, change control and risk management across global operations. Leadership and communication are essential to drive improvements and build a robust quality network.