Associate Director, Clinical Systems Quality

Location: Warsaw, Poland
Hybrid model of work: 3 days in office, 2 remote per week

The Associate Director, Clinical Systems Quality is responsible for supporting the delivery of Quality Management activities related to clinical development within R&D, working with stakeholders across the business  to embed quality/compliant practices while leading and guiding proactive inspection readiness activities within Development Operations and other Clinical R&D functions.

Accountabilities/Responsibilities:

• Establish and maintain effective systems and processes to support key performance areas for CQC to maintain Quality Management excellence
• Collaborate effectively with colleagues and stakeholders to support quality and compliance related initiatives/activities and act as a quality champion advocating a culture of quality across R&D. 
• Provide advice and best practice guidance on GCP or other relevant regulatory standards (such as GCP for labs, GAMP, 21 CFR Part 11, etc.)  for quality events, initiatives and improvement programs (issues/audits/inspections/ corrective/preventive actions [CAPA] and new/current business processes).
• Where necessary, provide support to stakeholders to ensure appropriate root cause analysis is conducted and CAPA plans (and in some cases, effectiveness check plans) are defined.  Assist functional partners with CAPA effectiveness checks.
• Assist functional representatives as they prepare for regulatory inspections (where necessary)
• Coordination of defined GCP systems audits and advising where necessary on other audit outcomes (responses, CAPAs, lessons learned)
• Support identification and management of quality risks, including mitigation of risks and communication of significant risks to management
• Assist with CQC communications and escalations
• Assist with identifying and implementing continuous improvements by collating including reporting quality related trends and metrics periodically, escalating where necessary,  and tracking related activities.
• Participate in any assigned operational committees and provide clinical quality expertise to external partners
• Actively participate in internal and external quality groups and fora sharing relevant information, experience/knowledge and best practices.
• Support CQC  Leadership in the strategic direction and priorities of the group. Contribute to CQC objectives and strategies that drive a culture of quality.
• Maintain current knowledge and awareness of  regulations / guidance as well as any internal processes pertaining to clinical trials;  provide interpretations of regulations and assessing impact on our systems and providing recommendations, where necessary.
• Provide quality and compliance support to assigned functional areas within Development Operations and R&D pertaining to the above.
• Review and scrutinize learning curriculum assignments and obtain senior CQC approval of final assignment to ensure appropriate and reasonable curricula are in place
• Assist in creation and maintenance of tools and processes to proactively address readiness for internal and regulatory GCP/GXP audits and inspections and development/maintenance of other tools and processes to support and enhance the above responsibilities.
• Conduct Quality Reviews for key validation documentation based on a risk-based approach
• Take on additional activities as assigned

Minimum Requirements –Education and Experience

Essential requirements for the role:

• University degree in related discipline, preferably in life science or equivalent. Higher degree in a scientific or business discipline is desirable
• In depth demonstrable experience in a clinical compliance or quality related position with a track record of success in managing quality and compliance activities
• Knowledge of current GCP guidelines and regulations, including ICH guidance and other regulatory requirements.
• Highly developed problem solving skills and the ability to resolve difficult conflicts
• Strong interpersonal and communication skills with the ability to influence others.
• Ability to multitask and to work efficiently and independently under pressure.

Skills and Capabilities

• Demonstrated project management skills
• Ability to motivate a team and work effectively within a team in a fast-paced, ever-changing environment
• Strategic thinking and planning
• Conceptual thinking
• Interpersonal skills
• Negotiation skills
• Influencing skills
• Ability to manage change
• Coaching and mentoring
• Ability to work collaboratively within a diverse environment (cultural sensitivity and diplomacy)
• Strong ability to work independently
• High ethical standards, trustworthy, operating with absolute discretion