Validation Manager

Are looking for a validation leadership role that allows you to leverage your technical expertise to drive quality assurance and compliance in a highly technical manufacturing environment? If so, this Validation Manager role could be an exciting opportunity to explore.

As a Validation Manager, you will be responsible and accountable for ensuring that the facilities, equipment, systems, and processes used in the manufacture and testing of biopharmaceuticals have been appropriately validated and maintained in a validated state

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

• This position provides the management resource required to lead validation efforts within the Biopharmaceuticals Supply Chain. The quality of the validation program has a direct impact on compliance to cGMP’s and the ability of the supply chain to gain regulatory
• approval to manufacture licensed biologics.
• Develop and maintain the Validation Master Plan for the Biopharmaceutical Bulk DS Production at the Upper Merion facility ensuring it reflects current practices.
• Define and optimize the overall validation strategies, policies, and programs. Programs to include change control as developed by the QA department. Strategic planning to include benchmarking against industry trends as well as continuous improvement in the validation program against current compliance standards and regulations.
• Manage the development and execution of validation protocols for all facility services, utilities, equipment, and systems including computer systems involved in regulatory processes.
• Manage the development and execution of the equipment cleaning validation program.
• This includes the development of a cleaning validation plan for each unique process or product.
• Manage the development and implementation of a validation maintenance program which periodically reviews the status of validated systems.
• Manage the development, implementation, and maintenance of validation documentation file organization and archiving procedures.
• Interface with appropriate regulatory inspectors on all validation issues, and present and defend the validation program in regulatory audits.
• Provide validation technical assistance to other GSK organizations when needed. Participate in cross organizational validation discussion and development efforts.
• Manage the validation group. Set priorities for self and staff within the guidelines set by supervision. Responsible for determining the need for, identifying, contracting, and managing the efforts of outside consultants and contractors when necessary to maintain the facility validation program compliant with regulatory requirements

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

• Bachelor’s degree in Engineering, Life Science, or equivalent
• 10 years of pharmaceutical industry experience
• 7+ years experience in manufacturing or development validation
• 4+ years Prior experience managing validation projects

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

• Prior experience in the validation of large scale bulk biopharmaceutical facilities including cell culture and/ or microbial fermentation, or protein recovery and purification operations.
• Prior experience supervising technical staff.
• Knowledgeable in current standards of typical biopharmaceutical utility service validations, cleaning and sterilization validations, environmental quality standards and validation of controlled areas, computer validations, biological and waste treatment validation.
• Experience in the regulatory inspection process is beneficial.
• Strong verbal and written communication skills.
• Must be able to interact well with peers, subordinates, and senior personnel in multidisciplinary teams involving scientific, engineering, regulatory, and operational disciplines.

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

• LI-GSK

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