QRA PDx Product Surveillance Specialist (Fixed Term Contract)

The Product Surveillance Leader will report to the Global Quality Risk Management & Complaints Leader in Pharmaceutical Diagnostics (PDx). The role is responsible for supporting the Complaints Handling Unit (CHU) Team in all post-market surveillance, regulatory and compliance activities in PDx. The role works closely with the Global Quality Risk Management & Complaints Leader, Site/Functional Product Surveillance and Global Pharmacovigilance (GPV) personnel to ensure that a compliant and effective complaints handling process is maintained in accordance with relevant industry guidance and applicable Standard Operating Procedures. The role is required to maintain oversight of post-market surveillance activities relating to Complaints management and completion, data analysis, training and competency of all personnel supporting the Complaints Handling process and continuous improvement of the post-market surveillance process. The role is responsible for design and development of Complaints Handling requirements to enable and support relevant PDx Product Surveillance & GPV personnel to remain compliant with, and competent on, the Complaints Handling process. This is a fixed-term 18 months contract position with the possibility of extension based on performance and business needs.,

• Key contributor to support the PDx post-market surveillance process
• Plays a key role in the design and development of support activities for the post-market surveillance process
• Ensure compliance with regulatory requirements such as FDA, EMA, and other international guidelines. Prepare and submit necessary reports to regulatory bodies
• Lead/Support and work closely with relevant PDx personnel to ensure post-market complaints are adequately investigated to continue to assure product safety and efficacy
• Communicate appropriately, and as relevant, with Customers / Complainants on the outcome of PDx Complaints & investigation activities
• Maintain detailed records of surveillance activities, incidents, and corrective actions. Prepare reports for regulatory bodies and senior management, as required
• Support a team of Product Surveillance Specialists as part of a Global CHU Team
• Maintain ownership and oversight of methods and procedures for effective complaint trending.
• Ensure timely completion of complaints and associated investigations
• Engage product design owners to determine the need for and effectiveness of Corrective and Preventive Actions (CAPA)
• Ensure timely handling of complaints that require further evaluation & support from PDx Manufacturing Sites / Functions
• Review and approve documentation related to investigation and complaint closure
• Support the development of training plans, conduct training, and maintain training records for CHU Team and relevant PDx personnel
• Lead metrics development, track and trend data to be used in Team Data Review, Complaint Review Boards, and Quality Management Reviews
• Support the development of risk management strategies to mitigate potential product issues.
• Foster and support a continuous improvement work environment
• Support other activities as deemed necessary to support PDx Business requirements
Quality Specific Goals
• Maintain awareness of and compliance with the GEHC Quality Manual, Quality Management System, Quality Policy, Quality Goals, and applicable laws and regulations as they apply to the Global CHU
• Complete all planned Quality & Compliance training within defined timelines
• Identify and report any quality or compliance concerns and take immediate corrective action as required
• Identify and report any compliance gaps related to applicable regulations and standards
• Ensure zero repeat findings from previous internal and external audits within area of responsibility
• Process and report complaints, metrics, and data in a timely and compliant manner
• Provide objective evidence of complaint handling process through compliant documentation
  
  Bachelor's or M.Sc. degree with appropriate, demonstrated experience in a Quality or Regulatory role within the medical device or pharmaceutical industry or equivalent
• Experience working with pharmaceutical/biologic products
Desired skills
• Knowledge and experience of Pharmaceutical GxP requirements
• Familiarity with TrackWise Digital Quality Management System and Veeva Vault Document Management System
• Proven ability to quickly assess situations and make decisions
• Proven ability to prioritise conflicting demands in an extremely fast paced environment
• Ability to work independently and in a team setting
• Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English (and where appropriate, be able to communicate in the local language verbally and in writing)
• Excellent interpersonal, organisational, and influencing skills
• Ability to analyze and process data and draw the appropriate conclusions
• Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
• Working knowledge of GEHC products
• Deadline and target focus with time management skills
• Solution mindset and familiarity with lean approach