R&D Supply QA Senior Manager

Are you a QA Manager passionate about delivering the next generation of medicines? This R&D Supply QA Senior Manager role could be a great opportunity for you.

As an R&D Supply QA Senior Manager, you will lead a team of Quality professionals overseeing clinical packaging and distribution activities. You will review manufacturing documentation and perform final batch disposition to ensure on-time in full clinical supply, while ensuring compliance with regulatory expectations and GSK internal requirements.

Job Purpose:

You will perform quality assurance activities and oversee GMP activities within R&D. You will be responsible for developing, planning, and executing QA operations to ensure the quality and GMP compliance of Investigational Medicinal Products (IMP) for clinical trials. You will lead and manage the quality assurance staff, ensuring that quality objectives are met and that Zebulon Site IMP/CTM supply operations comply with all applicable quality policies and procedures. Your role will contribute to the execution of the supply-chain strategy and its continuous improvement.

This role is part of the R&D Supply QA/QP leadership team within Quality R&D.

Key Responsibilities:

• Develop strategy, policy, group objectives, and processes in product Quality R&D and with business partners.
• Ensure products meet regulatory requirements and conform to regulatory submissions.
• Represent GSK interests with regulators and industry experts.
• Apply regulations and policies to unique and complex issues.
• Manage routine audits, regulatory inspections, and high-risk non-compliance issues.
• Manage resources, priorities, schedules, and projects to achieve group objectives.
• Foster an environment that optimizes employee productivity and adds value.
• Develop group skills and knowledge to meet changing needs.
• Lead direct reports or matrix teams and business processes.
• Engage in risk management activities and escalate risks and solutions.
• Coach, mentor, and train others.
• Represent the group in business contacts, management boards, or quality forums.
• Identify, communicate, and monitor business and regulatory changes impacting quality or compliance.
• Provide recommendations and solutions that improve and add value to internal and external customers.
• Communicate and interact at various levels within and outside GSK.
• Develop networks to communicate with key stakeholders.
• Engage in strategic and operational decisions on behalf of the group.

Specific Accountabilities:

• Review and approve GMP documentation, including validation documents, change controls, deviations, customer complaints, third party incidents, CAPA, and other controlled documents.
• Approve Standard Operating Procedures related to Quality Assurance and GMP systems.
• Manage internal assessment schedules and ensure compliance.
• Serve as Inspection Readiness site leader.  Develop and lead Inspection Readiness activities and Team (Internal and Regulatory Inspections)
• Participate in investigations and recommend corrective and preventative actions.
• Approve GxP training for business partners.
• Support site Change Control process/system
• Lead or provide support for risk assessments.
• Provide consultation/support for R&D validation activities.
• QA Support and Gap Assessment of Global Quality Policies
• Support development and implementation of IT systems and processes.
• Ensure third-party management activities, including supplier and contract resource organization assessments, are performed.
• Represent R&D site Leadership Team, prepare and deliver quality updates for Site Leadership Team forum.
• Prioritize batch release schedule (demand-capacity management) to ensure on time delivery of required supplies to meet clinical study timelines. Support Performance and Escalation forum. Develop and maintain Quality Assurance Agreements, Site Master File, and Technical Service Level agreements.
• Generate, review, and approve batch and packaging record templates.
• Review completed batch and packaging records.
• Perform material release activities for clinical studies (Non-EU Only).
• Generate, approve, and manage relevant release documentation.
• Provide project support, including preapproval audit activities.
• Coach, mentor, and lead quality team
• Train and develop team members, perform competency assessments.

Why You?

Basic Qualifications:

• Bachelor's degree in a science discipline.
• 6+ years in the pharmaceutical industry within qua