Head, Clinical Trial QA

CSL•King of Prussia, PA

About The Position

The Head of Clinical Trial Quality Assurance role maintain and enhance the Global Clinical Trial Quality System supporting Early to Late-stage clinical development projects within R&D, utilizing and improving the existing R&D Quality Management System in alignment with CSL overarching Quality Management System administered and managed by Global Quality. This position strategically oversees aspects of the R&D Quality Management in relation to key quality elements such as Document Management, Knowledge Management, Significant Issue / Serious Breach Management, Deviation and CAPA Management, Risk Management, Continuous Improvement, Inspection Management, Change Management and R&D Quality Governance associated with R&D clinical development. The role manages a Global Clinical quality department supporting early and late-stage clinical trials for all CSL business units across all R&D anchor sites. Develop and maintain an approach for inspection management related to clinical trials and the R&D QMS, focused on preparing CSLB for Sponsor Monitor inspections that will focus on R&D development programs. The Head of Clinical Trial Quality Assurance is a key leadership position for providing strategic direction and managerial oversight as the global footprint of CSLB expands. This is especially relevant as CSLB enters new emerging growth markets where integration and alignment with the global R&D Quality Management System is business critical.

Requirements

Undergraduate degree (BA/BS) in Scientific discipline/Life Sciences or similar. Advanced degree preferred
10+ years’ pharmaceutical company experience in Quality Assurance, Quality Management Systems and/or in a Clinical Development related role
Previous experience with inspection management preferred
Additional experience in Pharmacovigilance/GMP/Pre-Clinical related roles is desirable
Strong leadership role with experience in pre-clinical/clinical regulations and knowledge of international and national laws, regulations and guidelines related to the conduct of Research & Development
High ethical standards as well as acknowledged personal credibility, the ability to gain trust at the senior executive level
Visible and credible advocate for compliance and quality concepts with excellent communication skills across all levels of the business
Analytical and logical, can design and implement innovative, significant and complex business improvements
Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions, actions and resolutions
Experience of working in global cross functional teams, demonstrated ability in mentoring/ coaching/ directing staff to be quality advocates, influencers, leaders
Demonstrated ability to provide vision and leadership within teams, internally cross-company and externally with stakeholders
Experience in Quality Systems e.g. Deviation, CAPA and Change management processes
Sound customer focus, strong organization, communication (written and oral), influencing and negotiation skills
Proficient in English and standard MS Office applications

Responsibilities

Direct, manage, and strategically improve clinical quality assurance (CQA) function globally. Ensuring best use of capabilities, expertise, and harmonized processes/procedures within Global CQA to enable consistent implementation of standards, integrity of processes, structures and systems on a global scale, including emerging markets
Provide high quality GCP and cross functional consultancy expertise to guide the R&D organization and leadership in maintaining required compliance
Provide GCP and process related guidance and support
Works with teams/ senior management to investigate and resolve non-compliance, deviations and process related issues providing recommendations for solutions and CAPAs as needed
Ensure continuous assessment of key quality/performance indicators across entire pre-clinical and clinical system
Ensure the provision of accurate and timely reports on pre-clinical/clinical development metrics, findings, and trends stemming from audits, inspections and deviations and proposes and/or implements improvement initiatives, as needed
Lead appropriate governance meetings and ensure adequate attendance of CQA staff to relevant meetings globally where CQA input is required, e.g. compliance monitoring/ signals, and other governance bodies
Ensure analysis and reporting of audit observations, gaps and systematic issues to relevant CSL management functions to improve processes within Pre-Clinical/ Clinical Development as well as affiliates, 3rd party vendors and interfacing functions.
Evaluate adequacy and completeness of CAPAs originating from audits, deviations and/or inspections. Including communication and presentation of summaries of audit findings, trends, KPIs with recommendations to drive significant continuous improvement activities
Ensure timely reporting of serious GxP breaches to Regulatory Authorities, as required.
Develop and oversee a GxP appropriate significant quality issues management procedure
Provide leadership and guidance in the preparation, conduct and response preparation relating to health authority inspections and 3rd party audits
Direct/lead preparation activities for inspections and 3rd party audits; ensure preparation of inspection strategy plans and their timely implementation, lead/ direct mock inspections/ mock inspection activities
Ensure adequate communication of results and inspection preparedness to appropriate customer groups/ upper/ executive management
Act as primary Inspection Coordinator during inspections, including direct interaction with inspectors in preparation, during conduct and follow-up of inspection
Support CSL affiliates with external CQA audits and inspections
Globally direct and actively conduct for-cause activities and other complex compliance related investigations, as needed
Support of GMP/ PV health authority inspections, as required
Collaborate with other GxP area heads to ensure consistency in approach and to ensure there are no gaps or duplications of effort
Responsible for maintenance and further development of Global CQA systems and processes to ensure coordination and alignment with other CSL/Global Quality and compliance functions
Direct and oversee appropriate global workforce planning to ensure appropriate allocation and utilization of Global CQA and QMS resources
Develop and evolve partnership and collaboration with partnering functions
Contribute ideas to the larger strategic vision of Global R&D Quality/ Global Quality and interact with the respective Leadership Team to ensure continuous alignment on strategy and vision