Senior Quality Assurance Specialist

Responsibilities Operational support of Quality oversight of Third-Party Vendors within the API platform and the within TPQM team include: Generate, negotiate, review, assess, and approve Quality Agreements between our Company's Research Labs and its contractors and cross sites and division within our Company supporting clinical supply production. Generate, negotiate, review, and approve assessments for audit refusal and other related quality events at suppliers of GMP materials and services. Serve as quality representative in meetings with internal and external stakeholders, including Quality Disposition and Pharmaceutical Research/Development. Communicate clearly and effectively with internal and external stakeholders. Collect and track Quality Agreement metrics and other operational metrics. Act as TPQM gatekeeper and review GLOSS SOP changes, updates, and new SOPs for TPQM impact or awareness. Collaborate with internal teams and external contractor personnel on tailgate sampling, reduced testing assessments, risk assessments, supply chain mapping, and annual report authorship. Maintain the Quality Agreement Master List and related trackers with accuracy. Support internal audits and inspections as needed. Use, support, and continuously improve TPIC (Third Party Information Center) to enable TPQM workflows and operations. Collect and track Third Party oversight related metrics. Identify and implement process improvements, including opportunities to leverage AI tools. Communicate with senior our Company's leadership and contractor management. Prepare and present cross-functional management updates. Make independent decisions and act with appropriate authority. Identify trends and potential compliance gaps and lead issue resolution to improve quality and efficiency. Interpret regulatory requirements and communicate them effectively across stakeholders. Requirements A minimum of seven (5) years of relevant experience within the pharmaceutical industry OR Advanced Degree with a minimum of five (5) years relevant experience. Ability to independently engage with external parties. Strong cross-functional teamwork, collaboration, influence, and negotiation skills. Strong knowledge of EU, US, and ROW regulations and application of GMPs in an R&D environment. Knowledge of drug development process. Knowledge of continuous improvement methods; able to identify opportunities and implement solutions. Experience with AI tools applications to streamline workflows and replace manual work with automation when applicable. Strong organizational and time management skills; able to deliver well-defined projects within area of expertise. Ability to manage conflicting priorities proactively. Proficient with Microsoft 365 Office applications (e.g. Power Point, Word, Excel) Key Hard Skills GMP Quality Agreements audit refusal assessments risk assessments supply chain mapping process improvements AI tools applications drug development process continuous improvement methods regulatory requirements Key Soft Skills cross-functional teamwork collaboration influence negotiation organizational skills time management independent decision making communication problem resolution ability to manage conflicting priorities #J-18808-Ljbffr