Manager - PSOQ Clinical Complaints and Investigations

USE YOUR POWER FOR PURPOSE

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.  

WHAT YOU WILL ACHIEVE 

This Quality position is considered a global position and reports into the Global Clinical Supply Quality Assurance (GCS QA) Lead for Clinical Complaints and Investigations, within Pharm Sci Operation Quality (PSOQ) responsible for supporting Pharmaceutical Sciences.

This Manager position will primarily support the GMP/GCP interface specialty team within GCS QA and may lead to opportunities to move or rotate into the wider areas of GCS QA in alignment with Development Planning and/or Business need.

This Manager will be responsible for leveraging strong and collaborative partnerships with colleagues across PSOQ, Global Clinical Supplies / Clinical Development Operations, other Worldwide Research and Development organizations and PGS to support the management for the following areas: Clinical Complaints, Investigation management, and Management Notification activities. Additional responsibility will also include supporting the Local Process Owner (LPO) for clinical complaints, to meet investigational product requirements ensuring regulatory expectations are embedded with relevant procedures.

In addition, would be required to support Inspection/Audit readiness, data analysis and development and management of Spotfire and SharePoint platforms, also responsible for developing and enhancing processes to continuously improve and streamline existing quality processes to support activities, with knowledge and skills contributing towards the goals and objectives of the team.

ROLE RESPONSIBILITIES

Perform a range of duties within the GCS QA Clinical Complaints and Investigation team, associated with Quality Management Systems oversight, Quality Operational role for Clinical Complaints,  Investigations , Management Notification  and may be required to support Inspection/Audit  readiness , for which Duties may include some or all the following, at various times, depending on experience and job assignment:

• Responsible for leading /supporting the author, review, and approval of related moderately complex GMP deviations & product quality investigations and provide oversight to the timely closeout and effective investigation of clinical supplies, CAPA effectiveness, trending, and metrics.

• Responsible for leading /supporting the author, review, and approval of moderately complex clinical complaints, ensuring timely closeout, providing complaint management oversight for trending and metrics, CAPA effectiveness.

• Escalate issues as appropriate to the Quality Assurance Lead in a timely manner, with responsibilities for generating Notifications to Management/ Issue Escalations.

• Perform Management Notification activities, and May be required to participate/ support PSQRT/AQRT activities and outcomes.

•  Support the Local Process Owner for Clinical Complaints, ensuring Investigational Product (IP) needs are met and reflected, ensuring an IP fit for purpose model in the global documents.

• Tracking and Trending of metrics to measure Process effectiveness & mitigate risk at local level.

• Audit/Inspection support, collaborate with Global Clinical Supply, PharmSci Operation Quality and other groups in Worldwide Research and Development to support Regulatory agency inspections, Regulatory Quality Assurance, and Internal audits / Inspections.

• Applies skills and knowledge to Support continuous improvement, special projects and limited duration teams in the support model and management of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) activities for the investigational medicinal product process through partnerships with Global Clinical Supply and the wider Clinical Development Operations.

• Takes appropriate risks to Streamline compliance and simplify procedural and other requirements to ensure ease of following program requirements.

• lead quality risk management efforts in all areas/ disciplines within the team.

• Able to operate independently in ambiguous situations.

• Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues.

• Takes