Director, Clinical Systems Quality

hace 4 meses

Barcelona, España AstraZeneca A tiempo completo

**Location: Barcelona, Spain (On-site): We requiere 3 days working from the office and 2 days working from home.**

Join us as a Director, Clinical Systems Quality, where you will be responsible for the delivery of Quality Management activities related to clinical development within R&D. This role is a key collaborator with colleagues, other quality roles, and leaders across the business in R&D to advance quality management initiatives, address quality issues and provide advice for matters dealing with quality and compliance.

**Typical Accountabilities**:

- An advocate supporting the maintenance of Quality Management excellence within Clinical Operations and the wider BioPharma and Oncology R&D organization, where assigned.
- Acts as a quality champion promoting a culture of quality across R&D.
- Provide expert GCP/relevant regulatory and standard methodology advice and guidance into quality events (issues/audits/inspections/CAPAs and new/current business processes, improvement projects and initiatives).
- Support teams with internal and regulatory GCP audits and inspections.
- Support functions in preparation for upcoming regulatory inspections, which can include activities such as interpreting and completing readiness checklists, identifying risks and developing mitigation strategies, building quality issue storyboards, providing study team assistance & support during inspection and post inspection tasks (responses, CAPA, lessons learned)
- Coordinate defined GCP system/process/project audits and advise, where necessary, on other audit outcomes (responses, CAPAs, lessons learned)
- Coordinate and supports quality investigations.
- Develop and implement quality initiatives and improvement programs
- Where necessary, provide support to assigned staff 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. Advise and support if regulatory reporting is required.
- Identify, collate, review and report quality related metrics and trends periodically, bringing up priority items, where necessary. Identify continuous and quality improvement opportunities and steering their implementation, where necessary.
- Provide clinical quality expertise to external partners. Participate on any assigned steering, operational and/or governance committees
- Actively participates in internal and external quality groups and fora sharing relevant information, knowledge, standard methodologies and aligning/strategizing with other quality functions within the business where appropriate.
- Support Clinical Quality and Compliance Leadership Team in the strategic direction and priorities of the group and to develop CQC objectives and strategies that drive a culture of quality.
- Maintain an up to date knowledge and awareness of current and developing regulations / guidance as well as any internal processes pertaining to clinical trials; assessing impact on our systems and providing recommendations, where necessary.
- Provide functional support to assigned areas within Clinical Operations and other R&D groups pertaining to the above.
- Support resource management and workload assignments to ensure that CQC responsibilities are carried out effectively
- Mentor less experienced colleagues on areas of expertise
- Deputy for the Senior Director, Clinical Systems Quality as needed

**Education, Qualifications, Skills and Experience**

**Essential**:

- In depth demonstrable experience in a clinical compliance or quality related position with a track record of success in handling 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 and gain commitment.
- 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
- Critical 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, credible, operating with absolute discretion

At AstraZeneca, we follow the science to explore and innovate. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference. We have built our business around our passion for science. Now

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