Associate Director, Clinical Systems Quality
hace 5 días
Location: Barcelona, Spain (On-site): We requiere 3 days working from the office and 2 days working from home.
Join us as an Associate Director, Clinical Systems Quality and be part of our dynamic Biopharmaceuticals R&D team. In this role, you will support the delivery of Quality Management activities related to clinical development within R&D. You will work closely with collaborators across the business to embed quality/compliant practices while leading and guiding proactive inspection readiness activities within Clinical Operations and other Clinical R&D functions.
Typical Accountabilities:
- 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 standard methodology 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 vital)
- 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 critical issues
- Assist with identifying and implementing continuous improvements by collating including reporting quality related trends and metrics periodically, increasing where vital, 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. Supply 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 Clinical 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
Education, Qualifications, Skills and Experience
Essential:
- University degree in related field, preferably in life science or equivalent. Higher degree in a scientific or business subject area 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.
- 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
- Social 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, credible, operating with absolute discretion
At Astra Zeneca, we are driven by our desire to understand and reveal new insights. We are free from fear of failure, free to ask the right questions, make bold decisions, and dig deep into the biology of complex disease. We are committed to making an impact on patients' lives by improving patient access to healthcare globally. Our values guide everything we do at Astra Zeneca. They power our belief in What Science Can Do - a belief in its potential to redefine what's possible. We are always listening and learning from people who live with the diseases our medicines treat. It enables us to better understand their needs and, ultimately, diagnose and design the right treatments to impact patients' lives.
Are you ready to make a difference? Apply now and join us in our journey of discovery and innovation
Astra Zeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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