Job Description
Are you a seasoned Quality Assurance professional with a passion for pharmaceutical excellence? Veridian Pharmaceuticals, a leading innovator in life-changing therapies, is seeking a highly motivated and meticulous Senior Pharmaceutical Quality Assurance Specialist to join our dynamic team in Princeton, NJ. This is an unparalleled opportunity to ensure the highest standards of quality and compliance, directly impacting patient safety and product efficacy.
At Veridian, we are dedicated to pushing the boundaries of scientific discovery to develop cutting-edge medicines. Your expertise will be crucial in maintaining our rigorous quality systems, supporting regulatory filings, and fostering a culture of continuous improvement. If you thrive in a fast-paced environment and are ready to make a significant impact on global health, we invite you to apply.
Responsibilities
- Lead and execute internal and external audits (GMP, GCP, GLP) to ensure compliance with global regulatory requirements (FDA, EMA, ICH).
- Develop, review, and approve Quality System documents, including SOPs, policies, and quality agreements.
- Manage and investigate deviations, CAPAs, OOS results, and change controls, driving effective root cause analysis and timely resolution.
- Provide expert QA support for batch record review, product release activities, and stability programs.
- Participate in regulatory inspections and provide comprehensive responses to audit observations.
- Collaborate cross-functionally with R&D, Manufacturing, Regulatory Affairs, and Clinical teams to embed quality throughout the product lifecycle.
- Conduct training sessions on quality principles and regulatory expectations for staff across departments.
Qualifications
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field. Master's degree preferred.
- 5+ years of progressive experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- In-depth knowledge of cGMP, ICH guidelines, FDA regulations (21 CFR Parts 210/211, 820), and EU GMP Annexes.
- Proven experience with Quality Management Systems (QMS), including deviation management, CAPA, change control, and OOS investigations.
- Strong analytical, problem-solving, and decision-making abilities with excellent attention to detail.
- Exceptional written and verbal communication skills, capable of influencing and collaborating effectively across all organizational levels.
- ASQ Certification (e.g., CQE, CQA) is a significant plus.