QA Specialist Lead; 2nd Shift

Role Summary

QA Specialist Lead (2nd Shift) leads moderately complex quality assurance activities in pharmaceutical manufacturing. You will manage projects, resolve deviations, and ensure compliance with cGMP and quality systems. You will collaborate with internal and external stakeholders to support regulatory inspections and drive continuous improvement.

• Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work
• Make decisions to resolve moderately complex problems, develop new options guided by policies, and operate independently in ambiguous situations
• Utilize judgment and experience to potentially become a resource for others, and evaluate clinical and commercial drug batches to ensure adherence to specifications
• Identify deviations in manufacturing and packaging processes, approve investigations and change control activities, and guide operational teams in project management
• Prepare forecasts for resource requirements, identify areas for improvement, and facilitate agreements between different teams using leadership skills
• Assess supplier operations for regulatory compliance, conduct quality reviews, and report results to relevant medical and quality groups
• Support the development of country quality strategic initiatives, lead continuous inspection readiness, and drive effective management of quality issues and CAPAs
• Participate in internal cGMP audits, support regulatory inspections, perform disposition of clinical trial materials, and communicate with internal and external customers to resolve project-related issues
• Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues

• Required: BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience
• Required: Substantial experience in pharmaceutical manufacturing and quality control
• Required: Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects
• Required: Knowledge of regulations related to vendor management programs and other industry quality systems
• Required: Strong critical thinking skills and a proactive approach
• Required: Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally
• Required: Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM, Quality Tracking System Trackwise, and Documentum platforms
• Preferred: Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
• Preferred: Knowledge or exposure to data science
• Preferred: Strong leadership and team management skills
• Preferred: Ability to work under pressure and meet tight deadlines
• Preferred: Ability to influence and negotiate with stakeholders
• Preferred: Experience in conducting internal audits and supporting regulatory inspections
• Preferred: Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

• Leadership and team management
• Cross-functional collaboration and communication
• Strong critical thinking and problem-solving abilities
• Regulatory compliance and cGMP knowledge
• Data literacy and familiarity with quality systems
• Proficiency with MS Office and enterprise systems (PDM, Trackwise, Documentum) and ability to learn new tools

• Specific area/grade gowning required
• Capable of residing in a controlled environment for more than three hours
• Capable of standing for periods of more than one hour
• This role is 2nd shift 3pm–11pm, Monday–Friday with expectation to flex as needed to support business needs
• Relocation support available