Global Quality Control Lead

Site Name: USA - Pennsylvania - Upper Providence
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.
• Ensure timely response is provided to regulatory and customer queries, including support for deviations, change controls and other cGMP documentation.
• Follow GSK cGMP documentation practices and utilize approved systems for documentation.
• Provide timely review and analysis of data to support reference standard and controls qualification, re-qualification, stability and performance monitoring with RFT.
• Work 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 8 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.