External Quality Drug Substance Lead (Person in Plant)

Job Purpose
This individual will be the face of GSK quality at key, strategic suppliers, CMO’s, and/or alliances.  He/she will be accountable for implementing governance of and maintaining these relationships based on transparency and trust.  He/she will provide the on-site Quality and compliance oversight of production activities (specialty API, bulk drug substance, analytical testing, drug product, packaging) in order to ensure
GSK standards are met, to safeguard GSK’s patients, to protect GSK’s reputation, and to secure the BioPham and oncology clinical and commercial supply chains.
 
Responsibilities

• Responsible for building and maintaining direct Operational Quality oversight and management of relationships with strategic partners, alliances, and external suppliers. This includes, but is not limited to records review and approval, authoring and executing quality agreements, implementing governance, audit support, etc. 
• Leveraging a strong relationship built on trust and transparency, coach, mentor and influence suppliers to increase quality mindset and maturity to safeguard the GSK patients, the quality of our products, and our reputation.  
• Facilitate decisions concerning the quality of material and subsequent disposition; escalate issues and risks that may have an impact on supply in a timely manner.
• Identify and advance continuous improvement initiatives to ensure GMP expectations are met.
• Assure all quality issues are communicated and managed to GSK leadership in a timely manner; proactively identify and manage issues to ensure business continuity; work to quickly investigate and resolve emerging.
• Assure externally-made products are produced in compliance with registration details, GSK QMS requirements, and Specialty External Management Processes. Where deviations occur, resolve, mitigate, or escalate to senior management as necessary.
• Work with partners to ensure on-time/right-fist-time production, testing, and release of GSK products to meet supply chain demand.
• Assist External Suppliers with inspection preparedness planning including identification and development of storyboards, coaching, and identification of specific inspectional risks with a goal of continued inspection readiness.
• Support Product Incident Alerts, Stock Recoveries and Product Recalls; Serve as Issue
• Management/Product Incident Recall Committee Secretary.
• Report and drive resolution of cGMP/Regulatory compliance issues.  Request required legal documentation such as Certificate of Pharmaceutical Products (CPP), GMP certificate.
• Legalized and Notarized Declarations and documents as required by LOCs.
• Build and maintain good working relationships with internal partners, through compliance with applicable SOPs, Technical Terms of Supply and Service Level Agreement as applicable.
• Contribute to the evolution and implementation of GSK Quality Standards, the annual quality plan, and the overarching quality strategy
• Establish and maintain regular dialog with team members, individually and collectively, providing feedback and recognition.
• Monitor the training status of direct reports 
• Effectiveness with me measured by in-place/in-use Quality Agreements, GSK Corporate audits, delivery of successful regulatory inspections, and quality KPIs

Requirements

• Degree in Science or Engineering

• 8+ years of experience in Manufacturing, QC, Engineering, Validation or Quality Operations) AND/OR equivalency in education and experience.

• 7+ years of previous Pharmaceuticals industry experience in technical or quality role(s) with at least 2 years of API, biopharmaceuticals or sterile manufacturing/or QC laboratory experience.

• Well-developed technical, quality and regulatory knowledge of current biopharmaceutical analytical and manufacturing techniques and processes

• Sound understanding of quality systems and quality control processes

• 3+ years of operational quality or compliance experience or other relevant experience

• Demonstrated knowledge of GMP's, FDA, EU and other regulatory agency requirements with an ability to apply to quality and compliance

• Demonstrated knowledge of quality system principles and practical applications.

• Demonstrated knowledge and ability to apply quality and risk management principles and tools.

• Demonstrated problem solving skills.

• Demonstrated ability to make grade level decisions

• based on facts and data and application of risk management principles

• Experience with work related travel

• Excellent written and oral communication skills -English.

• Strong influencing and negotiating skills

• Demonstrated ability to develop staff

• Capable of managing across boundaries

• Solid knowledge of regulatory requirements including biological product and facility licensing requirements

• Proven ability to function independently, as a self-starter, and prioritize work.

• Thorough knowledge of cGMP's and ICH guidelines; demonstrated ability to implement these guidelines.

• Demonstrated sound decision-making skills.

• Demonstrated ability to lead work and collaborate within cross-functional teams (matrix management).

• Strong verbal, written communication and presentation skills.

• Solid understanding of Quality System principles and practical applicable, including emerging expertise in deviations/investigations/CAPA and Change Management.

• Demonstrated problem solving capabilities, with preference to direct experience in application of Excellence in Deviation Management (EDM), Human Factors Analysis, and/or GSK Production, System (GPS) principles.

• Prior contractor management experience desirable.

• Strong interpersonal and influencing skills.

• Demonstrated flexibility, ability to adapt and accommodate different/ multiple work demands.

• Strong understanding of current FDA/EMA validation practices including sterilization, cleaning, performance process qualification, shipping, computer systems, analytical methods.

• Solid understanding of drug development and manufacturing activities.

*LI-GSK

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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