Quality Technical and Validation Associate Director

GSK is currently looking for a Quality Technical and Validation Associate Director to join our team in Rockville, MD. The Quality Technical and Validation Associate Director provides leadership to a team Quality professionals and is responsible for ensuring the highest standards of GxP compliance in the validation and qualification activities, ensuring robust and compliant validation and change control efforts, providing GMP oversight on Continuous Process Verification process and GMP oversight on facilities and utilities (including maintenance, calibration and pest control programs).This role is pivotal in overseeing new product introductions (NPI) and associated manufacturing and analytical activities, ensuring seamless introduction of products from and to other supply nodes. The Quality Technical & Validation Associate Director reports to Site Quality Director and is part of the Quality Leadership Team.

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KEY RESPONSIBILITIES:

• GxP Oversight of Validation and Qualification Activities. Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory guidelines in the validation and qualification of processes, equipment, and facilities.
• Provide oversight and approval of the equipment cleaning validation program. This includes the cleaning validation master plan and validation maintenance.
• Review and approve equipment validation protocols for all facility services, utilities, equipment, laboratory equipment and systems including computer systems.
• Manage the change control process to ensure that all changes to processes, equipment, systems, and facilities are properly evaluated, approved, and documented and ensure oversight on change control requirements for validation and qualification activities.
• Provide GMP oversight to all Continuous Process Verification activities.
• Provide GMP oversight of facilities and utilities including maintenance and calibration, as well as pest control program.
• New Product Introduction (NPI): Provide quality oversight and approval of technology transfer activities to ensure adherence with GSK and regulatory standards. This includes review and approval of process and analytical tech transfer tasks and protocols, and dossier technical review.
• Work with enterprise partners (R&D, global MSAT/validation, Product Quality Leads) in identifying, evaluating and initiating product quality strategies.
• Support PAI and routine regulatory inspections through subject matter expertise as a fronter of topics or a host, as necessary.
• Provide leadership and direction to a team of 5-10 quality professionals, fostering a culture of quality and compliance.
• Actively participate in the Quality Leadership Team (QLT) to contribute to the overall quality strategy and objectives.

Basic Qualifications:

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

• BS Degree
• Minimum of 8 years' experience in the biopharmaceutical or pharmaceutical industry
• Minimum of 4 years' experience in a Quality or Technical (Production, MSAT, Validation, i.e.) role

Preferred Qualifications:

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

• Validation and transfer/ process validation expertise (preferred)
• 3+ years in leadership experience managing team
• Knowledge of cGMPs, FDA and other Regulatory requirements.
• Experienced with FDA or other health agencies' inspections
• Working knowledge of cGMP regulations including process validation/cleaning validation and product characterization guidelines.
• Must be able to interact well with peers, subordinates, and senior personnel in multidisciplinary teams involving scientific, engineering, regulatory, and operational disciplines.
• Capable of providing direct supervision in a team-oriented atmosphere.
• Excellent written and verbal communication, presentation, report writing, influencing, listening and networking skills.
• Demonstrated initiative and results focused problem solving/troubleshooting skills.
• Effective at technical quality decision making and at implementing decisions
• Good understanding of site business drivers.
• Proven ability to influence others and foster collaboration.
• Proven ability to champion change and innovation

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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.

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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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