Senior Director, R&D GMP Quality & Ops

GlaxoSmithKline; Marietta (PA); On-site; USD 220,000 - 320,000; Full time

Job summary

GSK is seeking a Quality R&D GMP Ops Senior Director to lead a global quality organization for R&D GMP manufacturing, storage and distribution. This role ensures all steps from seeds and cell banks to drug products comply with cGMP/cGDP and drives QMS improvements, governance, and regulatory readiness.

The Senior Director will build capabilities, lead change initiatives, and manage EHS and people development while aligning with GSK strategic objectives and product launches.

Qualifications

• Master's degree in Bioengineering or related field.
• Ten+ years of quality experience in a regulated environment.
• Five+ years of experience in cGMP globally and new product introduction.
• Three+ years of experience determining phase appropriate requirements for clinical supply and commercial PAI requirements for commercial.
• PhD in bioengineering or related field (preferred).
• Strong leadership and interpersonal skills to engage, empower and influence people.
• Ability to navigate complex compliance environments and regulations.

Responsibilities

• Lead the quality organization in R&D GMP manufacturing, storage and distribution activities, ensuring all production steps for seeds and cell banks, API, drug substances and drug products are compliant with cGMP/cGDP.
• Ensure implementation of high-quality processes and systems (QMS) to support full compliance to cGMP, regulatory expectations and GSK standards.
• Oversee Quality Governance, Quality Oversight and Management of regulatory observations, deviations, CAPA, Change Control, standards and trainings.
• Manage quality issues with identification, impact evaluation on quality, safety and potential impact on clinical data, and remediation planning.
• Identify proactively and manage potential quality and business risks.
• Host quality inspections and audits, ensuring inspection readiness.
• Support product and technology transfers to GSK or CMO as needed.
• Represent Quality R&D positions/views in meetings, and influence across the organization.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance

Technical Writing

Education

Master's degree in Bioengineering or related field

Job description

GSK is seeking a Quality R&D GMP Ops Senior Director to lead a global quality organization for R&D GMP manufacturing, storage and distribution. This role ensures all steps from seeds and cell banks to drug products comply with cGMP/cGDP and drives QMS improvements, governance, and regulatory readiness.

The Senior Director will build capabilities, lead change initiatives, and manage EHS and people development while aligning with GSK strategic objectives and product launches.