Global Quality Control Lead

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Site Name: USA - Pennsylvania - Upper Providence, UK - County Durham - Barnard Castle
Posted Date: Apr

GSK is currently looking for a Global Quality Control Lead to join our team. In this role, you will be accountable for maintaining reference standards and critical reagents for all commercial products within the GSK network. They ensure that all the reference standards and critical reagents remain qualified, maintained per regulatory and Quality requirements, inventory is actively managed to ensure no impact to product supply and long-term availability of reference standards and critical reagents to GSK sites, CMOs and LoC.

KEY RESPONSIBILITIES

• Maintain Biopharm critical reagents and reference standards supporting commercial or late phase projects to ensure uninterrupted supply across GSK network.
• Collaborate with R&D, MSAT, Product Quality Strategy Leaders, GSK commercial Quality Control or contract manufacturing testing labs, and Regulatory Affairs to ensure commercial reference standards remain qualified per regulatory and quality expectations, as well as teams to enable seamless standards and reagents associated with new product introduction.
• Administer the critical reagents/reference standard inventory program and support the effective transfer to and from sites for commercial and late phase projects. Ensure there is robust inventory maintained at all times and inventory replenishment plans are in place ahead of time, including regulatory change management for uninterrupted supply of reagents.
• Support and manage as required standards and critical reagents life cycle, apply appropriate statistical tools to assess Control/Standards performance and stability over time consistent with ICH requirements and current regulatory expectations.
• Assume responsibility for writing and reviewing SOPs, protocols, and other laboratory documentation, in support of these standards and reagents, as necessary.
• Ensures timely response is provided to regulatory and customer queries, including support for deviations, change controls and other cGMP documentation.
• Follows GSK cGMP documentation practices and utilizes approved systems for documentation.
• Provides timely review and analysis of data to support reference standard and controls qualification, re-qualification, stability and performance monitoring with RFT.
• Works closely within and across departments in matrix teams for RFT and on-time delivery of tasks.
• Develop templates, guidelines, SOPs and project plans to simplify and standardize across the network.
• Support audit and inspections preparation, as requested.

Why you?
Basic Qualifications:

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

• Bachelor's degree in biochemistry, analytical chemistry or related degree.
• Minimum of 10 years' experience in the biopharmaceutical/pharmaceutical industry.
• 5+ years of analytical experience within cGMP QC/QA units or R&D analytical lab.

Preferred Qualifications:

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

• Ph.D. degree or equivalent education background preferred.
• Prior experience in Reference Standards and critical reagents qualification and management is highly preferred.
• Cold Chain distribution, inventory management, and other logistical experience are highly desirable.
• Familiar with statistical trending.
• Strong Project Management skills.
• Strong technical writing abilities and in-depth knowledge of cGMPs, biopharmaceutical manufacturing processes.
• Strong familiarity with FDA/EU/ICH and ROW regulations and guidance.
• Microsoft Windows experience required, with technical proficiency in Word, Excel, Empower, LIMS, and other laboratory IT systems typically used in the industry.
• Excellent written and verbal communication skills, ability to interact with both internal and external parties.
• Ability to work both independently and within a team environment.

Why GSK?

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

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.