Job Description
Are you ready to influence the future of life-saving therapeutics? Nexus BioPharm Solutions is seeking a detail-oriented Senior Pharmaceutical Quality Assurance Specialist to join our elite team in the heart of the Kendall Square biotech hub. You will play a pivotal role in ensuring our manufacturing processes adhere to the highest global standards, directly impacting patient outcomes.
We offer a dynamic, collaborative work environment where innovation meets rigorous compliance. If you are passionate about GxP standards and data integrity, we invite you to advance your career with us.
Responsibilities
- Oversee and maintain Quality Management Systems (QMS) to ensure full compliance with FDA and EMA regulations.
- Conduct thorough internal and external audits of manufacturing facilities and laboratory documentation.
- Manage CAPA (Corrective and Preventive Action) investigations to identify root causes and implement effective solutions.
- Review and approve batch records, validation protocols, and analytical reports with precision.
- Lead cross-functional teams in preparing for regulatory inspections and audits.
- Develop and deliver specialized training programs on current Good Manufacturing Practices (cGMP) for production staff.
- Author and revise Standard Operating Procedures (SOPs) to align with evolving industry standards.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
- Minimum of 5-7 years of direct experience in Pharmaceutical Quality Assurance or Quality Control.
- Expert-level understanding of 21 CFR Part 11, ICH Q7, and cGMP/GLP regulations.
- Proven ability to manage complex investigations and resolve technical compliance issues independently.
- Exceptional documentation skills with high attention to detail in data integrity practices.
- Strong communication skills, capable of liaising with regulatory bodies and internal stakeholders.
- ASQ certification (e.g., CQA or CQE) is highly preferred but not required.