Job SummaryThe Sr. Associate, Compliance is responsible for overseeing vendor management and ensuring supplier quality compliance, while also providing scientific and technical support for quality investigations, including OOS, OOT, and product quality complaints. This role drives effective root cause analysis, timely closure of investigations, and adherence to GLP, cGMP, and Quality Management System (QMS) standards. The individual manages and enhances electronic quality systems (eQMS), including TrackWise, supports cross-functional collaboration for investigation and documentation activities, and leads initiatives to improve QMS efficiency and compliance. Additionally, the role includes analyzing quality data and trends, preparing Annual Product Quality Reviews (APQRs), and presenting quality metrics and risk assessments to support continuous improvement and informed decision-making.
Area Of Responsibility- Review and assess vendor SCAR (Supplier Corrective Action Reports) and ensure effective follow-up.
- Ensure vendor-supplied products comply with regulatory and quality standards.
- Develop and maintain strong, long-term relationships with approved vendors.
- Evaluate new vendor capabilities, conduct onboarding interviews, and communicate expectations and compliance requirements.
- Establish performance standards and continuously evaluate vendor performance.
- Identify opportunities to enhance and optimize vendor management programs.
- Support vendor selection initiatives to ensure engagement with qualified and compliant suppliers.
- Support and collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
- Work directly on technical investigations relating to Product Quality Complaints
- Provide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiries
- Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
- Plan and coordinate routine and non-routine projects requiring independent judgment, evaluation and selection of compliant scientific techniques
- Perform statistical analysis of critical attributes and trending of QMS events for each commercial product and provide a scientific rationale for the outcome of the conclusion presented in the APQR.
- Prepare Annual Product Quality Review (APQR) report for each commercial product as per predefined timeline.
- Compile and report on Quality metrics at monthly Quality meetings, creating presentation materials to identify trends, quality and compliance risks, and make recommendations for changes to processes, procedures, and training, as applicable
- Manage electronic Quality Management System (TrackWise)
- Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
- Develop presentation monthly for QRB meeting based on eQMS, Quality Matrix and Monthly Quality investigation Board (QIB) meeting.
- Follow up with stake holders for timely closures of all open QMS documents and update TW accordingly. Finally, present the status/findings to QRB meetings.
- Drive projects to improve the QMS for compliance through Trackwise (TW), efficiency, or corporate needs
- Author/revise standard operating procedures (SOPs) and test methods, as required
- Other duties as assigned
