Senior Director, R&D GMP Quality & Operations

SHPE Houston; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

GSK seeks a Senior Director to lead Quality R&D GMP operations, overseeing pilot plants, and ensuring cGMP/cGDP compliance across manufacturing, storage and distribution. You will guide teams, drive change initiatives and uphold regulatory standards in a global context.

Ideal candidates hold advanced degrees, extensive cGMP experience, and proven leadership in quality governance, risk management, and cross-functional collaboration for product launches.

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.

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, including the release of intermediate batches are done in compliance with cGMP/cGDP.
• Ensure implementation of high-quality processes and systems (QMS) to support full compliance to cGMP, regulatory expectations and GSK standards, managing risks as appropriate.
• Ensure the Quality Governance, Quality Oversight and Management of regulatory observations, deviations, CAPA, Change Control, written standards, trainings, management monitoring.
• Ensure that quality issues are adequately managed with identification and characterization of the issue, impact evaluation on quality, safety and efficacy as well as potential impact on clinical data, ensuring timely escalation to upper management including remediation plan proposals.
• Identify proactively and manage potential quality and business risks.
• Host quality Inspections and quality audits, ensure Inspection Readiness
• Support as appropriate product and technology transfers to GSK or CMO
• Represent Quality R&D department positions/opinions views in all meetings, establish good GSK network and educate and influence by his/her behaviour, compliance to good quality practices
• Provide clear direction, build team and people capability, career development; provide leadership for change initiatives involving processes, product, technologies, digitalization, culture and people.
• As leader, be responsible to ensure all people remain safe at all time, ensure preventive measures are implemented and employees have the necessary skills and medical aptitude, manage EHS risks, EHS incidents.

Skills

Quality leadership

cGMP compliance

Regulatory knowledge

Quality systems (QMS)

Risk management

Cross-functional collaboration

Operational excellence

Data analysis

Process improvement

Communication

Education

Master’s degree in Bioengineering or related field

PhD in bioengineering or related field

Job description

GSK seeks a Senior Director to lead Quality R&D GMP operations, overseeing pilot plants, and ensuring cGMP/cGDP compliance across manufacturing, storage and distribution. You will guide teams, drive change initiatives and uphold regulatory standards in a global context.

Ideal candidates hold advanced degrees, extensive cGMP experience, and proven leadership in quality governance, risk management, and cross-functional collaboration for product launches.