Site Name: USA - Pennsylvania - Marietta
Posted Date: Jul 3 2024
Are you a Quality Professional looking for a challenging opportunity to drive Quality Management System improvement and simplification for your local region while working with Quality Managers across the globe? If so, this could be a great position to explore.
As an Operational Quality Supervisor, you will be responsible for directly supporting aseptic manufacturing operations as an embedded member of the Value Stream. As the Operational Quality Supervisor, you will be leading the QA team responsible for implementing and administering QA systems for the production of biologics at the Marietta facility and ensuring compliance with GSK internal procedures, policies, standards, and external regulations.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Ensure all validation, quality, safety and environmental procedures and regulations are met, maintained and documented appropriately.
- Supervise the performance and development of QA Operational Specialists by displaying the GSK expectations of a leader and using GSK’s performance management systems.
- Accountable for the QA oversight and decision making in aseptic vaccine formulation, filling, lypholization, visual inspection, and leak detection operations and associated validation to ensure compliance with regulatory requirements.
- Engage in problem solving and construct innovative solutions to complex manufacturing problems while maintaining compliance with regulatory requirements and product quality.
- Coach & mentor QA Operational Specialists and Operations team members and act as point of contact for final decision making authority within their team.
- Coordinate work for the QA Operations team to facilitate day to day activity prioritization.
- Provide advice and counsel on cGMP and related quality assurance issues to QA Operations Team members.
- Review and approve deviation investigations and corrective/preventive actions as assigned.
- Ensure appropriate assessment of product impact in alignment with the expectations of aseptic operations.
- Manage deviation/CAPA systems to ensure closure of open items within established timeframes.
- Set goals and expectations of each batch and manage timelines.
- Provide real time GMP and QA support and decision making to customers. Instill a sense of urgency in team for daily prioritization and customer service.
- Responsible for communications with the Operational Quality Manager regarding decisions, issues and escalations.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s Degree
- Minimum 5 years' prior experience in the pharmaceutical industry
- Minimum 2 years of experience with aseptic operations
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- BS/BA in biology, chemical engineering, life sciences.
- Prior experience interfacing with regulatory agencies, as well as exposure to the regulatory submission process.
- Validation experience.
- Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
- Training and work experience in root cause analysis tools (Isikawa) and statistical analysis (TQM, SAS) required.
- Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance.
- Working knowledge of validation principles, quality systems and FDA regulations.
- The ability to communicate both verbally and in writing with all levels both inside and outside of the organization.
- The ability to clearly write QA documentation as necessitated by regulatory agencies an internal policy.
- Able to prioritize and decide appropriate course of actions and to effectively implement decisions.
- Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.
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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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