Director, R&D GMP Quality & Operations

Biopharma Careers; Upper Merion Township (Montgomery County); On-site; USD 180,000 - 300,000; Full time

Job summary

GSK in the US seeks a Quality R&D GMP Ops Senior Director to lead the QRD quality organization for GMP manufacturing, storage and distribution, ensuring cGMP/cGDP compliance across seeds and cell banks, API, drug substances and products.

You will build the team, drive change initiatives, oversee QA governance, inspections, and product transfers while partnering across R&D and external partners to accelerate launches and maintain the highest quality standards.

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.
• PhD in bioengineering or related field.
• Strong leadership skills to motivate, engage and develop capabilities.
• Strong interpersonal skills with demonstrated ability to engage, empower and influence people.
• Ability to make decisions even under pressure and navigate in grey zones.
• Ability to define priorities and critical thinking to understand risks and elevate.
• Ability to analyse data, identify trends and draw conclusions; excellent problem solving skills.
• 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.

Responsibilities

• Lead the quality organization in R&D supporting 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

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance (QA)

Risk Awareness

Technical Writing

Education

Master’s degree in Bioengineering or related field

PhD in bioengineering or related field

Job description

GSK in the US seeks a Quality R&D GMP Ops Senior Director to lead the QRD quality organization for GMP manufacturing, storage and distribution, ensuring cGMP/cGDP compliance across seeds and cell banks, API, drug substances and products.

You will build the team, drive change initiatives, oversee QA governance, inspections, and product transfers while partnering across R&D and external partners to accelerate launches and maintain the highest quality standards.