Sterility Assurance Lead (Associate Director)

At GSK, 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.

As a Sterility Assurance Lead, you will play a vital role in ensuring the sterility and quality of our manufacturing processes. You will collaborate across teams to implement and maintain robust sterility assurance programs, ensuring compliance with regulatory standards. This role offers the opportunity to make a meaningful impact on patient health while growing your expertise in a supportive and inclusive environment. If you are passionate about quality and innovation, this is your chance to contribute to GSK's mission of getting ahead of disease together.

You will provide vital support and expertise to ensure the highest sterility assurance standards by overseeing processes such as Aseptic Practices, Environmental Monitoring, Cleaning and Sanitization, Sterilization, and Media Fill to guarantee the quality, efficacy, and safety of products.

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

• Be the key contact for the Site for all matters related to Sterility Assurance including Aseptic Practices, Environmental monitoring plans, Surface Cleaning and Sanitization, Sterilization, Media Fill and Sterility Failures and provides expert support to production, engineering and QA.
• Coordinate the team which define, organize and maintain over time the (1) proper microbiological environmental and aseptic operator monitoring plans, (2) the proper microbiological monitoring plans for Utilities and other microbiological samples (e.g. prefiltration bioburden) and (3) execute media fills for the initial validation and re-validation.
• Coordinate, organize and execute other validation activities such as biovalidation, facility and utilities validation.
• Maintain and ensure aseptic procedures are in place and in use.
• Support investigations where aseptic assurance is at risk.
• Project support for aseptic assurance. Oversight of microbial control strategy.
• Be active member of aseptic member quality network. Manage cost center.
• Ensures the structure is appropriately sized and fosters the development of team members' skills.
• Promotes a collaborative and stimulating work environment where everyone can contribute.
• Encourages professional growth through training, regular feedback, mentoring, and coaching programs, ensuring each team member has opportunities to excel and contribute to the organization's overall success.
• Responsible for ensuring that Risk assessments, Risk communication and action planning are completed in accordance with our Risk Management System (RMS) within the relevant business area. Risks may be relevant to Business, Business continuity, Safety, People, Wellbeing, Compliance, Quality, Costs.

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

• Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific field.
• Minimum of 5 years of experience in sterility assurance or aseptic manufacturing within the pharmaceutical, biopharma or biotech space.
• Experience with regulatory inspections and audits.
• Experience with aseptic techniques and cleanroom operations.

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

• Advanced degree in Microbiology, Biology, Chemistry, or a related field.
• Experience in a leadership role within sterility assurance or quality assurance.
• Knowledge of risk assessment tools and methodologies.
• Familiarity with validation processes for aseptic manufacturing.
• Strong problem-solving and analytical skills.
• Strong knowledge of regulatory requirements for sterility assurance (e.g., FDA, EMA).
• Proven ability to lead investigations and implement corrective actions.
• Excellent communication and collaboration skills.

This role is on-site and based King of Prussia, PA. If you're ready to make a difference and grow your career, we encourage you to apply today!

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.

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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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