Clinical Supplier Quality Program Manager
Cambridge, MA | Contract
Are you someone who likes to travel for work, organized, and experienced in a scientific field? Check out this great new opportunity in the Boston area!
- Ensures clinical, bioanalytical, pharmacovigilance (PV), and R&D marketed product supplier/partner/vendor audits are conducted in accordance with requirements.
- Ensure external suppliers/partners/vendors meet quality standards.
- Develops and maintains a global supplier/partner/vendor audit schedule.
- Manages the global consultant auditor process, including identifying and managing the ongoing performance of auditors as well as the audit process.
KNOWLEDGE AND SKILLS:
• In-depth knowledge of the interpretation and application of FDA and international clinical trials regulations and guidance, and ICH Good Clinical Practice guidelines.
• Knowledge of global Good Pharmacovigilance Practices (GVP)
• Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to subject safety and data integrity.
• Negotiation Skills: Demonstrates proficiency in negotiation and conflict resolution.
• Clinical Development: Understands the phases, processes and techniques used to execute a clinical development program.
• Product Knowledge: Understands the medical/therapeutic impact of products.
• Scientific Knowledge: Possesses the necessary science education and knowledge to manage quality assurance oversight for clinical trials and to assure the ethical treatment of subjects. Understands medical terminology, standards of care, and disease states.
• Communication skills: Must communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing. Must demonstrate professional presentation skills.
• Project Management: Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
• Organizational skills: Must be able to prioritize work effectively to meet timelines.
• Interpersonal: Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
• Computer skills: Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members. Must be proficient in use of the Quality Assurance Audit Database (QAAD).
• ASQ Certified Quality Auditor (CQA) or SQA Registered Quality Assurance Professional certification preferred.