Compliance Manager/ATPS/Pharma/Welwyn Garden City/£850pday
We are recruiting for a leading Pharmaceutical business, based our of Welwyn Garden City who require a senior figure to come in and head up the ATPS/compliance division.
The APTS Manager provides direction, leadership and expertise in all GCP compliance activities to the Affiliate Process, Training and Systems group.
The role is accountable for ensuring all GCP governed clinical activities in CCO are delivered to the highest standards of quality and efficiency in accordance within the client and industry requirements and regulations. The APT manager leads quality and compliance excellence within the local CCO organisation by embedding quality principles throughout the organization, across all clinical studies conducted within the affiliate.
The following accountabilities are applicable to both PDG CCO and Local MA.
Main Accountabilities and Responsibilities
- Accountable for providing leadership and direction to the Affiliate Process, Training and Systems group, maximizing the productivity and contribution of the APTS group through effective management of performance, communication and relations, as well as, through individual development and coaching.
- Accountable for management of CCO UK quality activities, including compliance checks, local CAPA documentation and follow-up and local GCP/GVP metrics in order to effectively manage risk in the affiliate.
- Leadership of CCO for GCP audits and inspections, accountable for ensuring the CCO affiliate is GCP-inspection ready and acts as the Single Point of Contact for audits/inspections
- Accountable for providing strategic direction ensuring that global and regional APTS business plans/goals and country business priorities are met within the affiliate.
- Proactively identifies opportunities for continuous quality improvement and ensures effective knowledge and best practice sharing within and outside APT.
- Accountable for ensuring effective partnership in quality related matters with internal functions, local, regional and global quality groups and external vendors, ensuring, where applicable, effective implementation of Roche GCP quality standards and processes.
- Accountable for ensuring the CCO affiliate is effectively implementing ICH GCP, global division procedural documents, regulatory and local law requirements to ensure delivery of quality data and maintain patient safety.
- Identify, assess and resolve quality issues within CCO
- Lead the implementation of relevant global, regional and local initiatives, as required.
- Leadership in recommending, writing, approving and implementing improvements to relevant GCP procedural documents, processes and/or tools to ensure optimal quality standards and efficiency.
- Accountable for development and delivery of global, regional, and local training on procedural documents and business processes, as required; Ensure, through effective collaboration and metrics, that affiliate employees are appropriately trained on all relevant local/regional/global processes.
- Ensure ICH GCP related training interventions are recorded and training records are available.
Skills, Experience and Competencies
- Expert knowledge of ICH/GCP, client SOPs and local regulatory requirements; as well as, clinical research or development including operational aspects of clinical studies
- Strategic agility - Provides clarity and focus on a few key priorities
- Decision making - Pushes decision making to the lowest appropriate level and develops employees' confidence in their ability to make those decisions
- Managing change - Effectively manages change; explaining the context, answering questions, and patiently listening to concerns
- Teamwork and collaboration - Finds and attracts highly talented and productive people
- Achieving results - Clearly conveys objectives, deadlines and expectations
- Proven project management skills to work with a variety of different systems and stakeholders and deliver commitments on time and with quality
- Demonstrated computer literacy, usage of MS Office software, web-based systems and databases
- Communication: Excellent ability to present clear messages accurately in both written and spoken English from complex information/data to all levels in the organization
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