Director, Regulatory Compliance Quality Operations
Location: England, UK
Requisition Number: 5802
Position Title: Director, Regulatory Compliance Quality Operations
SUMMARY: Reporting to the EVP Global Quality, the Director RCQO is responsible for oversight, planning, leading execution of GxP standards and compliance for Worldwide’s systems, operations and facilities. Working cross-functionally with the Operations teams focusing on the delivery of clinical quality services to the company.
- Provide regulatory intelligence/surveillance for GxP requirements globally. Identify quality impact and actions and advise on requirements for Worldwide systems, processes and training.
- Partner with all functional operational areas, including Regulatory, Clinical, Data management, Technical Operations, Pharmacovigilance, and Early Phase teams, as appropriate, to achieve Quality objectives.
- Serve as a GCP/GxP subject matter expert for Worldwide Operations
- Oversight of Clinical Systems Validation and digital data GxP compliance for Worldwide systems
- Undertaking compliance oversight for new systems and operations championing a quality by design approach.
- Identify, and guide continuous improvement in GxP compliance for Worldwide processes, operations and systems
- Advise and direct on GxP requirements for new offices or business activities
- Oversight of quality and compliance requirements for Decentralized Clinical Trials
- Responsible for management and oversight of Quality Management Systems actions (deviations, quality issues, CAPA and Change control relating to relevant operations.
Performs other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Demonstrated organizational leadership competencies
- Demonstrated ability for driving results and role modeling as a cross functional collaborator
- Demonstrated ability to effectively communicate, escalate, and influence the outcomes of decision-making process
- Demonstrated project management and decision-making skills
- Communicates professionally, concisely, clearly, and consistently to external and internal customers both verbally and in writing
- Demonstrated ability to think critically and lead calmly in complex situations, with strong decision-making skillset
- Acts without authority to drive performance and accountability
- Ability to lead a team of individuals with a clear vision and defined purpose
- Demonstrated skills for influencing, being resourceful, managing conflict and negotiating
- Demonstrates an advanced aptitude for facilitating group or project initiatives
- Works with a sense of urgency; ability to recognize time sensitivity and leads assertively
- Has an advanced understanding of clinical research principles and processes for clinical trials
- Experience with identifying and implementing regulatory changes within life sciences organizations
- Previous experience with leading / participating in Regulatory Authority Inspections e.g.: FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, or other international Regulatory inspections
- Bachelor’s degree or equivalent required; MS in a scientific or allied health field preferred.
- 12+ years of relevant GxP experience
- Experience of clinical, phase I and laboratory operations and systems
- Experience in Quality CSV and DCT systems OR: Knowledge of Clinical System Validation and Decentralized Clinical Trials Quality compliance requirements
- Advanced working knowledge of ICH Guidelines, FDA regulations, European Directives, UK Statutory Instruments. Broad expertise related to understanding the GxP global requirements – regulations, laws and guidelines with the ability to identify key requirements and changes as they relate to Worldwide
- Advanced understanding of the Drug Development Process
- Understanding of 21 CFR Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature
- Domestic and international travel required (approximately 10-15%)
Employment Type: Regular
Community / Marketing Title: Director, Regulatory Compliance Quality Operations
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.
Location_formattedLocationLong: London, GB