Operational QA Manager

Job content

Site Name: USA - Pennsylvania - King of Prussia, UK - London - Brentford

Posted Date: May 19 2022

Are you energized by a highly specialized technical role that leverages the latest in quality analytical technology and method development? If so, this Operational QA Manager role could be a great opportunity to explore.

As an Operational QA Manager, you will manage Specialty API, bulk drug substance, analytical testing, drug product, and/or packaging external manufacturing quality assurance operations and compliance activities with leadership and

direction of R&D project team(s) and PSC supply, technical and specialty product team(s). Provide and/or facilitate decisions concerning the quality of material disposition or rejection. Responsible for the Operational Quality management relationship with strategic partners, alliances & external supply contractors for Specialty products. Responsible for assuring timely supply of product & maintenance of GSK reputation from a quality perspective. Contribute to the establishment of GSK Quality Standards for products within the scope of Specialty External Manufacturing. Manage issues and risks identified in area of responsibility

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Recommend and manage implementation and continuous improvement of quality processes and procedures required to ensure GMP expectations for GSK external suppliers are met.
• Build & maintain trusting relationship with external partners whereby influence can be applied & accepted to assure GSK quality standards are met.
• Establish, implement and sustain an operational quality oversight model in compliance with GSK quality expectations & accounting for contractual complexities & strategic project requirements
• Supports the governance structure for quality oversight of External Suppliers that assures GSK product are in compliance with registered detail, QMS requirements and Specialty External Management Processes
• Directly manages external suppliers as assigned.
• Manage activities to ensure on time/Right First-Time testing and disposition of bulk drug substance & finished product manufactured by External Suppliers to meet supply chain demand.
• Assure quality issues are managed to safeguard GSK’s patients, ensure business continuity & protect reputation.
• Contribute to and manage implementation of quality strategy from the QMS or from project leads as applicable.
• Where deviations from the above policies or the manufacturing process occur, e.g. registered detail, resolve, mitigate or escalate to senior management as judged necessary
• Actively manage records produced by External Suppliers, to ensure timely and appropriate outcomes for Quality and Production systems.
• Develop/negotiate or maintain quality agreements as required by QMS.
• Assurance that GSK’s Quality Management System is applied to External Supply practices demonstrated through effective Quality Agreements, GSK Corporate audits & delivery of successful regulatory inspections.
• Assist External Suppliers with inspection preparedness planning including identification and development of storyboards, coaching and identification of specific inspectional risks.
• 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 for LOCs.
• Build & maintain good working relationships with internal partners, through compliance with applicable SOPs, Technical Terms of Supply and Service Level Agreement as applicable.
• Maintain regular dialog with team members, individually and collectively, providing feedback and recognition. Monitor the training status of direct reports
• Resolution, mitigation or rapid escalation of issues impacting quality, safety or efficacy of Specialty products.
• Support Product Incident Alerts, Stock Recoveries and Product Recalls; Serve as Issue Management/Product Incident Recall Committee Secretary
• Assist in development of budget as requested.
  

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Bachelors Degree in Science or Engineering discipline and at least 8 years experience (Manufacturing, QC, Engineering, Validation or Quality Operations) OR Masters and at least 6 years experience 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.
• 3+ years of operational quality or compliance experience or other relevant experience
• 5+ years experience GMP’s, FDA, EU and other regulatory agency requirements with an ability to apply to quality and compliance
  

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• 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.
• Proficient presentation skills
• Proven ability to manage teams
• Strong influencing and negotiating skills
• Demonstrated ability to develop and coach staff
• Capable of managing across boundaries
• Solid knowledge of regulatory requirements including biological product and facility licensing requirements
• Thoroughly knowledgeable of cGMP’s and applicable ICH guidelines.
• Demonstrated sound decision-making skills.
• Demonstrated ability to lead work and collaborate within cross-functional teams.
• Able to prioritize and decide appropriate course of actions.
• Strong Project Management skills
• Expertise in deviations/investigations/CAPA and Change Management. Solid understanding of Quality System principles and practical applicable, including emerging
• Leads root cause analysis activities as necessary using established tools.
• Supervisory experience necessary (1-3 years).
• Operational Excellence exposure.
• 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 clinical manufacturing activities.
  

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

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