Pharma Quality Assurance

This is a hybrid position, local candidates only.

Description:
This individual will work in the Global Quality System & Strategic Transformation organization supporting global projects and initiatives. Activities include all aspects of project management for Drug Shortage Prevention Plans (DSPP), creation of deliverables, working with stakeholders and driving technical enhancements. The individual will directly work with the Global Quality Risk Management team and be responsible for establishing and maintaining records. DSPP work involves active collaboration with a cross-functional team in manufacturing sites, external manufacturing, regulatory, supply chain, product quality, compliance, and other global functions. This global function includes monitoring, tracking, and supporting various efforts and initiatives in the Quality System.

Responsibilities:

• Lead meetings to facilitate and/or support the DSPP Project.
• Actively collaborate with a cross-functional team to complete project milestones and DSPPs per
• established timeline.
• Assist the functional areas on completing the DSPP risk factors and input in the DSPP.
• QA review of DSPP content in compliance with established governing documents.
• Oversee, monitor and track key deliverables associated with DSPP Implementation Project Metrics and
• related initiatives.
• Support other DSPP Project deliverables or initiatives as requested.

Qualifications:

• Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area.
• Minimum of 5 years of experience in Quality Assurance and/or Quality System oversight. Risk Management, supply chain, compliance and drug shortages experience preferred.
• Lead meetings with technical professionals and experience in leading cross-functional teams with a results-orientated approach.

Preferred:

• Knowledge of regulatory documents such as ICH, US / EU and other key GMP regulations.
• Skills: Result-oriented, strong oral and written communication skills, excellent interpersonal skills,
• initiative, attention to details, time management in a fast-paced environment, teamwork, problem solving
• and project management.
• Computer system skills including Microsoft Office; proficient in Power Point and Excel.

What are the top 3-5 skills, experience or education required for this position:
1. Project Manager (Pharma)
2. Quality Assurance experience (Pharma); more than 5 years
3. Experience in Quality Risk Management, compliance, drug shortages