Under the direction of the Head, Clinical Vendor QA & Compliance, this position is responsible for leading and supporting the QA and Compliance activities for assigned clinical vendors managed by the Clinical Development and Global Medical Affairs organizations. The person in this position has the depth of understanding, experience in GCP and compliance, leadership, communication skills and business acumen to conduct responsibilities with minimal support.
Key areas of accountability for this role are to provide professional expertise and leadership in Good Clinical practice (GCP), Good Pharmacoepidemiology Practice (GPP), and applicable regulations and guidance and to proactively identify and escalate (as required) compliance status and issues/risks for assigned clinical vendors.
Primary responsibilities include but are not limited to collaboration with various internal R&D functions and external stakeholders, including contract auditors and vendor representatives, ensuring a high level of quality and consistency; contribute to the audit strategy and execute the audit and compliance plans and activities for assigned clinical vendors; assist teams in implementing corrective and preventive actions related to clinical vendor services and activities; and support a culture of sustainable compliance and inspection readiness.
Clinical Vendor Audit Management
Participate in the development of the audit strategy for clinical vendors that support Clinical Development and Medical Affairs programs/studies. Leads the execution of the audit activities associated to GCPs, GPPs, and applicable regulatory requirements. Assume the SOP defined "Program Lead" roles and responsibilities. Collaboratively work with key stakeholders from Program QA & Compliance, Program/Project teams, Audit Coordinators, and clinical vendor management groups to ensure audit plan execution. Coordinate with Quality Operations audit support staff, as required. Ensure appropriate audit responses and corrective and preventive actions are completed in a timely manner. Assist in the review and identification of potential systemic gaps and coordinates with the appropriate stakeholders to ensure timely remediation. As appropriate, escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management. Timely updating of information in appropriate audit trackers/systems.
Clinical Vendor Quality Management
Liaise with vendor QA staff and provide QA&C oversight for assigned clinical vendors contracted to provide services for clinical and medical programs. Participate as QA&C representative in clinical vendor meetings. Work with vendors and other internal R&D functions to perform root cause analysis of compliance issues for clinical vendors and support implementation of corrective and preventive actions as needed.
Execute the overarching strategy related to proactive and sustainable compliance for the assigned clinical vendors. Consult in compliance matters related to clinical vendors. Participate in process improvement initiative development and review of SOPs, Policies, Charters, etc. and review of relevant documents, as needed.
Regulatory Agency Inspection Support
Supports regulatory agency inspections activities related to clinical vendors for GCP/Sponsor Monitor inspections, and investigator site audit inspections, as needed.
Education & Experience Requirements:
• Bachelor's degree in a life science required; Masters' Degree in management or scientific discipline a plus.
• At least 7 years of pharmaceutical experience, preferably GCP.
• Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance, and GCP auditing.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.