GMP Quality Systems
- Job type Contract
- Salary competitive
- Location Cambridge, Massachusetts
- Sector Pharma & Biotech, Quality Assurance (QA), Regulatory Affairs (RA)
The candidate is responsible for managing, documenting, investigating small molecule, oncology, and any activities related to corporate procedure and regulatory standards. Responsibility scope includes timely management to complaint processes to comply with EU, FDA regulations. Identifying, solving, and improving any potential product deficiencies originating from market complaints. Primary Quality liaison with individuals, businesses inside and outside the organization regarding matters related to product complaint activities.
-Primary contact for commercial and clinical product complaints and post market product monitoring processes
-Departmental procedures assessing product complaints impact on patient safety and product QC
-Thoroughly investigate complaints within required time line
-Conclude product complaint investigations using current product complaints management software and coordinate all aspects of investigation
-Collaborate with various departments including External Supply, QA, Regulatory, Development, Safety and/Pharmacovigilance,
-Interface with stakeholders, CMO, Call Centers, vendors and contractors on product complaint issues
-Interact with Senior Quality, GMS leadership, cross-functional teams and any external parties
- Strong experience with subject matter expertise in small molecule, and complaints process or multiple Pharma quality management systems
-Combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits.
-Experience of cGMPs, EU, FDA, regulatory requirements governing combination drugs and device products
-Good understanding of the manufacture of combination products and the linkage to customer complaints.
-Ability to listen and relay complex information into clear and concise points
-Bachelors with minimum of 6 years' experience in Quality Assurance or GMP related within medical device, biotechnology/pharmaceutical manufacturing
Sthree US is acting as an Employment Business in relation to this vacancy.