Job Purpose:This position oversees the quality control operations in the Biopharm Upper Merion Laboratory, which is a strategic global hub that supports GSK's innovative specialty pipeline. As a commercial and launch facility, the laboratory also tests batches at large scale, to support the supply of new and existing oncology and respiratory products. This position is responsible for the dynamic strategy and technical requirements for assay transfer, digital transformation, and interfacing with R&D and Clients (site scope of work includes contract testing in addition to internal GSK manufacturing). Essential functions include planning and prioritizing resource allocation to meet testing requirements for the manufacturing facilities/utilities, the clinical and commercial operations, and the stability program for the specialty pipeline. Other functions include external laboratory investigations related to product testing, compiling reports in support of product filings with the regulatory agencies. The QC Director is responsible for the review of regulatory submissions (IND, BLA and MAA) and ensures the laboratory is prepared for Regulatory Inspections.
Key Responsibilities:- Ensures a cGMP laboratory to meet the work demand in support of global stability & release, local manufacturing, and development work as needed.
- Leads the laboratory through innovative changes to new technologies, paperless testing, seamless data flow, and other automation initiatives.
- Represents the Quality Control department and departmental functions on projects/committees within GSK, to ensure delivery of the specialty medicine pipeline.
- Leads and empowers a team of lab leaders to ensure the laboratory is a data factory with analysts and systems that support the sampling, testing, and generation and review of data per ALCOA principles.
- Ensures that the Quality Control team continues to grow technically and professionally; encourages their development efforts toward excellence and a higher degree of proficiency.
- Provides leadership by ensuring compliance of the department with laws, regulations, guidelines, procedures, and practices governing analytical Quality Control testing, including the departmental and company Standard Operating Procedures, and safety procedures.
- Ensuring that processes are in place to ensure that records and technical data are accurately maintained and results well documented.
- Provide support of product filings with regulatory agencies (IND, BLA MAA etc.)
Why you?Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in science discipline required
- 12+ years' experience in biopharmaceutical industry, particularly in the area of assessing physiochemical characteristics of product purity, activity and functional indicators of biological products
- 7+ years of supervisory and managerial experience
- Experience leading teams comprised of varying levels of technical expertise and functions.
- Fully versed in GMP's, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of analytical and stability functions
Preferred Qualifications:If you have the following characteristics, it would be a plus:
- Ph.D in a science discipline
- Demonstrated success developing teams.
- Strong verbal and written communication skills.
- Able to interact with peers, subordinates and senior personnel in multidisciplinary environments including development, engineering, facility operations, validation, production and QA.
- Able to prioritize and decide appropriate course of action. Effective at implementing decisions.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-###-#### (US Toll Free) or +1 801 ### #### (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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