Research & Development Quality Operations Specialty Lead

Position Summary

You will play a key role delivering operational quality activities that protect patient safety and ensure reliable supply across manufacturing and supplier partners in the United States. You will collaborate closely with manufacturing, supply chain, regulatory, and external teams. We are looking for clear decisionmakers who simplify quality processes, coach others, and drive continuous improvement.

Key Responsibilities

• Develop and incorporate effective processes and procedures in Quality R&D Operations.
• Support validation activities for new site commissioning and qualification (C&Q), and lead the implementation of Quality Systems to ensure operational readiness.
• Approve GMP documentation, including Standard Operating Procedures, pre and post approve batch records, validation documentation, change controls, and other controlled documents from business partner areas.
• Participate in investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.
• Participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high-risk non-compliance issues.
• Identify business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
• Participate in the implementation of the Quality Management System including, provide subject matter expertise and perform relevant impact assessments, attend quality council, consider quality policies as part of control document approval.
• Lead and contribute to the training, education, guidance and influencing of customers and business compliance practices.
• Provide advice and consultancy to GSK project teams and external partners to reduce regulatory risk.
• Identify and mitigate compliance risks through effective assessments and/or via providing advice and consultancy to Quality R&D and business units regionally and globally.
• Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments.
• Provide operational quality leadership and oversight for assigned external manufacturing partners and GMP areas.
• Serve as the first point of contact for quality concerns.
• Review and approve GMP documentation such as batch records, deviations, change controls, and controlled documents from suppliers and internal teams.
• Lead investigations and root cause analyses for deviations, complaints, and non-conformances.
• Drive corrective and preventive actions through to closure.
• Support product introductions, transfers, and implementations with quality input and risk assessments.
• Help prepare teams and suppliers for regulatory inspections.
• Monitor quality performance through metrics and trend analysis.
• Escalate risks and partner with cross-functional teams to implement improvement plans.
• Coach and influence suppliers and internal teams to harmonize processes and strengthen quality compliance and efficiency.

Basic Qualifications

• Bachelor’s degree required in scientific, engineering, pharmacy, or related discipline.
• Minimum 5 years of experience in Quality roles in a highly regulated environment (EMA/ FDA/ MHRA).
• Minimum of 5 years’ experience in pharmaceutical, biologics, or regulated manufacturing or quality roles.
• Must have fluency in both written and verbal English language.
• Demonstrate experience and knowledge of technical and operational domains within an R&D changing environment and more specifically for aseptic formulation, filling, freeze drying, visual inspection activities in GMP environment.
• Experience with cGMP and regulations applicable to GSK in the relevant countries (FDA/EU/WHO and other countries) and quality systems, including handling deviations, corrective and preventive actions (CAPA), change control, and document control.
• Experience reviewing and approving GMP documentation and batch records, working knowledge of Good Manufacturing Practices (GMP) and applicable U.S. regulatory expectations.

Preferred Qualifications

• Experience providing quality oversight for external suppliers or contract manufacturers.
• Familiarity with supporting regulatory inspections and preparing related quality responses.
• Skilled in data trending, root cause analysis tools, and statistical methods.
• Excellent problem solving and negotiation skills with the ability to make sound decisions using facts, good judgment and balancing GMP/GDP, regulations, quality, business, and patient interest.
• Ability to drive change and continuous improvement, communicate complex information.
• Experience across multiple dosage forms, packaging operations, or device assembly activities.
• Demonstrated ability to lead investigations and implement effective CAPAs.
• Experience coaching or leading operational quality teams.