Director, Clinical Supply Quality

Working with Us
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Position Summary
The Director, Clinical Supply Quality is a critical management position within the PD/R&D Quality organization that is responsible for the global regulatory compliance of our clinical supplies and oversight of clinical supply quality activities. The Director, Clinical Supply Quality is responsible for internal packaging at New Brunswick, global labelling operations, ISR studies, PAA/PSDA studies, IMP supply and management at sites. The position provides leadership for the identification and resolution of critical quality issues that may affect BMS. The Director, Clinical Supply Quality will act as Quality Culture ambassador across CSO, CSC, SQIMQ and GDO with responsibility for influencing senior leadership across BMS with respect to the importance of building continuous quality improvements into the organization. Reports to Senior Director, Clinical Supply Quality. Manages QA Operations personnel.

Key Responsibilities

• Quality Culture ambassador to collaborate and influence across CSO, CSC, SCIMQ and GDO, with responsibility for influencing senior leadership across BMS with respect to the importance of building continuous quality improvements into the organization.

• Authorized Person, responsible for the release of Investigational Medicinal Products in accordance with the requirements laid down in the Australian Government Therapeutic Goods Administration Guidance on Release for Supply.

• Oversight/Disposition of Additional Labeling activities at warehouse level outside of EU QP Oversight (Collaborate with SCIMQ As appropriate).

• Accountable for the global regulatory compliance of our clinical supplies and the resolution of any issues prior to certification by the QP team within the EU.

• Accountable for GCP Health Authority inspections and audits at clinical sites.

• Lead the CSCQ (SCIMQ)/CSQ LT meetings utilizing metrics and digital methods.

• Lead Support for GCP inspections IMP agenda.

• Lead Clinical Stock Recovery and Mock Stock Recovery.

• Support NTM’s - Back Up to PDQ Lead​.

• Collaborate with SCIMQ for IMP Supply Management.

• Oversees/provides compliance consultation to stakeholders on quality issue management and process enhancement/compliance - ensuring consistent quality standards and fostering strong working relationships.

• Promotes high standards of quality, compliance, and process excellence through oversight of procedure development/enhancement as well as by leading or contributing to supportive initiatives to ensure delivery of business goals.

• Incorporate global regulatory trends and changes into Clinical Supply Quality.

• Engage with executive management and cross functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement.

• Continually evaluate the strategic approach, drive changes in PDQ processes, and modify the PDQ program to meet the changing needs of the organization, regulatory environment and industry best practice.

• Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project/products, to business partners and senior management.

• Build and maintain a Clinical Supply Quality organization by creating an environment that attracts, develops and retain high-quality employees.

• Develop hiring plans to staff critical areas in PD Quality and establish the necessary infrastructure to ensure alignment with corporate objectives.

• Provide leadership, coaching, professional development, mentoring, and