Director, QA Audits and Inspections program - UK - Home-based

Requisition Number: 7984

Position Title: Director, QA Audits and Inspections Program Management

External Description:

Who we are

Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.

Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What you will do

• Mentors and leads a team of Quality professionals and ensures quality deliverables, on time, and in compliance with regulations and Worldwide processes for all Audit and Inspection activities.
• Participates in the crafting of the QA organizational goals and objectives as assigned.
• Assists in planning and optimizing resources (budgets, staff and technologies) for the advancement of the QA’s goals and objectives for the Audits & Inspections Program.
• Leads and/or conducts various types of audits, as requested, including for cause, vendor, internal process, site audits.
• Participates in the development and review of Quality Management Documents (SOPs, WIs, etc.)
• Supports the management of the vendor audit program as it relates to vendor audit assignments to direct reports.
• Assists with tracking and reporting of Key Quality Indications (KQI) and Quality Tolerance Limits (QTL) for the Audit & Inspection Program.
• Manages and oversees the execution and resourcing of the internal and contracted audit schedule
• Support of Worldwide Sponsor audits, and lead Worldwide and Sponsor inspections, as needed.
• Develops training material and/or delivers training related to Audits and Inspections
• Serves as a Subject Matter Expert on QA Quality Management processes for Audits and Inspections.

 

What you will bring to the role

• Ability to work with minimal supervision and guidance.
• Strong leadership skills with the ability to manage and motivate a team.
• Demonstrates excellent organizational leadership competencies, inclusive of scheduling and leading team meetings that are effective, efficient and documented.
• Works with a sense of urgency; ability to recognize time sensitivity and leads confidently
• Demonstrates excellent ability to effectively communicate and influence the outcomes of decision-making process
• Demonstrates excellent skillset for influencing, being resourceful, managing conflict and negotiating.
• Demonstrates ability to work collaboratively with cross functional stakeholders to drive process improvements based on Quality Indicators.
• Demonstrates the ability to implement risk management strategies.

Your experience

• Bachelor’s degree with concentration in scientific or allied health field and minimum of 10 years of relevant GCP, GVP and GcLP Auditing globally.
• Minimum of 5 years of managerial experience and management of audits.
• Completion of extensive GxP audit training.
• Experience in conducting QA Audits, specifically GCP for each type (i.e. Clinical Investigator Audits, Vendor Audits, Internal Process Audits, For-cause Audits, Document Audits).
• Experience in conducting training sessions for individuals on GxP compliance and audits
• Excellent working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, and AIFA CRO Decree.
• Possesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP, GcLP, GLP, GVP, GPP, Device and GMP knowledge.
• Previous experience with FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, PMDA inspections, EMA GCP inspections, or other international Regulatory inspections in the last 3 years.
• Domestic and international travel required (approximately up to 30%)

 

We love knowing that someone is going to have a better life because of the work we do. 

To view our other roles, check out our careers page at www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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Employment Type: Regular

Community / Marketing Title: Director, QA Audits and Inspections program - UK - Home-based

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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