Quality Control Director

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.
We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary

The Quality Control Director oversees the quality control operations in the Rockville Biopharm Laboratory. Essential functions include planning and prioritizing resource allocation to meet testing requirements for the manufacturing facilities/utilities, commercial operations, and the stability program for site products and additional specialty pipeline.

This position is also 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). Other functions include: external laboratory investigations related to product testing, compiling reports in support of product filings with the regulatory agencies. The incumbent reviews and releases test results, and ensures full cGMP compliance in the laboratory operations. The QC Director also reviews regulatory submission (IND, BLA and MAA) and supports internal and external audits, and Client and Regulatory Inspections.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Ensures a cGMP laboratory to meet the work demand in support of manufacturing and development work as needed.

• Provides in depth technical and scientific advice and guidance to laboratory supervisors and analysts in the Quality Control Laboratory and Operations.
• 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 departmental laboratory and manufacturing related investigations are completed in a timely manner.
• 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.
• Ensures that processes are in place to ensure that records and technical data are accurately maintained and results well documented.
• Represents the Quality Control department and departmental functions on projects/committees within GSK.
• Provide support of product filings with regulatory agencies (IND, BLA MAA etc).
• Analytical and microbiological testing and release of all components, raw materials, excipients, intermediates, active pharmaceutical ingredients (APIs), finished product and stability samples, if applicable.
• Sample management, including retain and stability samples as required
• Environmental and utilities monitoring (microbiological assurance and process control).

Why You?

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree in a life science, chemistry, engineering or related discipline.
• 10+ years industrial experience in biopharmaceutical industry, such as Biochemistry, Analytical Chemistry, Microbiology or related field,
• 8+ years of supervisory and managerial experiences

Preferred Qualification

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

• Demonstrated success leading a team comprised of varying levels of technical expertise and functions.
• Demonstrated success developing teams.
• Strong verbal and written communication skills.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including development, engineering, facility operations, validation, production and QA.
• Able to prioritise and decide appropriate course of actions. Effective at implementing decision.
• Fully versed in GMP's, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of analytical and stability functions

#LI-GSK

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 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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call.

Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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