Senior Director, Quality R&D, GMP Ops

GSK

Senior Director leading GSK’s R&D GMP quality operations for vaccines and medicines. Overseeing compliant manufacturing, quality systems, inspections, transfers and team capability.

Posted 9/11/2026full-timeUpper Merion • Pennsylvania • 🇺🇸 United StatesSenior💰 €132,750 - €221,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in cGMP compliance, quality management systems, and regulatory requirements, with a strong focus on leading quality initiatives and managing risks in a regulated environment. Proven ability to build team capabilities and drive operational excellence while ensuring safety and quality standards are met.

Highest-signal resume keywords

CGMP ComplianceQuality Management System (QMS)Regulatory SubmissionsOperational ExcellenceLeadership and Team Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality GovernanceRegulatory ObservationsCAPA ManagementChange ControlData AnalysisClinical Supply RequirementsValidationKPI ManagementRisk ManagementQuality Inspections

Soft Skills

Strong Presentation SkillsDecision-MakingCritical ThinkingInterpersonal SkillsProblem-Solving

Certifications & Qualifications

Master’s Degree in BioengineeringPhD in Bioengineering (Preferred)

Industry Keywords

GMP ManufacturingCGDPRegulatory ComplianceFacility RegistrationProduct Technology TransfersEHS Risk Management

About the role

Key responsibilities & impact

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 escalate 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

Requirements

What you’ll need

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

Benefits

Comp & perks

Annual bonus
Eligibility to participate in the share based long term incentive program
Comprehensive benefits program for US employees
Accommodation or other assistance to apply, where required