Location: Marietta,PA, USA
Site Name: USA - Pennsylvania - Marietta
Posted Date: Oct 24 2024
Are you energized by a highly specialized technical role that leverages the latest in quality analytical technology and method development? If so, this Quality Assurance Manager role could be a great opportunity to explore.
As a QA Manager, you will be responsible for building and leading the Quality Assurance team that will ensure the transfer of Drug Product processes and test methods to Marietta meets GSK and GMP guidelines. You will also provide direct QA support of initial start-up activities (such as facility design and equipment requirements) and will wrive excellence In Quality Assurance Leadership and Management.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following
* During the project phase, the QA Team Leader will be responsible to help drive the Quality oversight for the direction of all Drug Product processes and testing through to operational readiness, as well as provide QA oversight of validation program execution for these processes. Collaborate with other project teams, and with QA departments at other sites to align strategies and procedures. QA support for regulatory application and filing.
* Once in operation, you will continue to ensure that all DP systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration, QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation. Additionally, you will participate in optimization or improvement initiatives and support regulatory agency inspections.
* Provide QA oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process, testing and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
* Generate, review, and approve QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
* Ensure that project and operational quality objectives are met within desired timelines.
* Actively seek opportunities to collaborate and align with other GSK sites to streamline processes and maximize efficiency.
* Effective verbal and written communication skills.
* Excellent interpersonal skills, with the ability to form good working relationships with people at all levels.
* Think broadly, identify and understand implications to the entire organization.
* This role and the associated responsibilities will develop as the project matures, and startup activities evolve into operations.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
* Bachelor's Degree in chemistry, Bio-chemistry, Microbiology, or related scientific discipline
* 7 years of directly related managerial experience in a pharmaceutical industry overseeing QA, QC, Regulatory or Operations.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
* Lean / Six Sigma training and certification preferred.
* Certification or training in quality systems or cGMP compliance by a recognized organization such as ASQ preferred.
* Versed in GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to comply to quality operations and compliance.
* In-depth experience in quality systems, including validation, documentation, compliance in a high volume, rapid turnaround release office or compliance department.
* Strong technical understanding of industry and science practices related to the business.
* Strong communication and problem-solving skills with a demonstrated ability to work well with and influence others with and without direct reporting relationships.
* Risk Management Principles and Technique.
* Successful Interaction with internal and external customers, cross-functional leadership, capability to drive governance across functions and stakeholders.
* High learning agility and analytical skills.
* Flexibility, tenacity, strong logical approach to problem solving, pragmatic and results driven, can-do attitude to help the organization deliver stretch goals, structured organized excellent planner, ability to coach staff on all different levels of the Quality organization, ability to influence and get buy-in of senior management, mediate and drive critical programs forward.
* Be an excellent negotiator when the workload is conflicting and jeopardizes program deliverables.
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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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