Position Purpose:
The Batch Release Associate is accountable for continued supply for the supply of CSL's early and late stage clinical trials worldwide. This role serves as a Release Responsible/Authorized Person for IMP for ROW and is direct Quality Assurance partner with Clinical Trial Supply (CTS) with specific quality oversight of GxP Compliance (i.e., GCP, GMP, GDP, etc.).
Reporting Relationships:
The role reports to: Head of Clinical Trial Supply
The role has no direct line management responsibility
Main Responsibilities and Accountabilities:
1Generate and review batch documentation as well as perform batch release actions to assure the continued uninterrupted supply of CTM from Technical release of in-process intermediates, drug substances to drug product and final packed and labeled IMP.
• Perform oversight of deviations, corrective/ preventative actions (CAPAs) and effectiveness checks impacting all aspects of CSL IMP
• Ensures that IMP is labelled and packed consistent with clinical trial designs, in accordance to CSL release specifications, regulations and international and local standards and requirements
• Provide Quality oversight to transport verification on shipments of clinical material to depots.
• Assure proper QMS documentation is generated to accompany lot releases.
• Collaborate with CTS personnel and relevant Quality units to ensure proper and timely processing of PTCs.
• Ensure appropriate maintenance/ administration of BT systems (i.e., Plateau, ODRS and TrackWise) used in support of Clinical Supply Quality.
2.Oversee and ensure compliance to GMP/GSP or other GxP requirements
• Review of GMP and non-GMP batch documentation supporting CTM product release
• Review of batch documentation for systems checks
• Provide Quality oversight and strategic guidance to R&D change controls, deviations, observations and out of specifications activities, as appropriate to assure proper documentation review and completeness within QMS
• Perform relevant change control implementation tasks
3.Provide support during audits and inspections
• Participate in vendor audits as Subject Matter Expert for CTS-related audits
• Support the global CTS team to prepare for internal audits and Competent Authority (CA) Inspection related activities
4.Support Quality Oversight of relevant third-party vendors
• Review /Revise Quality Agreements to ensure CSL and Regulatory requirements are maintained
• Acts as preliminary escalation point for CTS in case of vendor specific Quality complaints
5.Provide guidance to R&D departments regarding quality related issues with batch documentation as well as associated deviations, change controls and out of specifications
6.Ensures an effective operating model for partnering with CTS vendors, including processes, standard operating procedures, work instructions, roles and responsibilities, and electronic data exchange/system interfaces. Oversees implementation at all CTS vendors.
7.Support development and implementation of standards across CTS vendors (e.g. packaging & labeling standards, distribution & return standards, and deviation management).
Position Qualifications and Experience Requirements:
Education
University degree (BSc, MSc, PhD) in life sciences, engineering, logistics or equivalent experience
Experience
Minimum of 5 years experience in clinical supply management, clinical research, product development and/or global R&D project management in the biopharmaceutical industry including 2 years in clinical drug supply roles with global responsibility
Competencies
Required:
• Comprehensive understanding of global clinical trial and clinical supply chain processes
• Knowledge and experience in GCP/GMP/GDP principles including relevant international standards and regulatory requirements/regulations related to clinical development
• Strategic thinking and development
• Vendor management and governance
• Demonstrated experience leading process improvement projects
• Analysis, problem solving, judgement and sound decision-making skills
• Ability to collaborate across all levels within the organization and with external parties
• Effective interpersonal, negotiation and influencing skills
• Excellent English language written and oral communication and presentation skills
• Customer focus
Additional Comments:
Travel approximately 20%.
