Associate Director, Quality & Compliance Business Planning & Operations, Da

at  AstraZeneca

WHY JOIN US?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.
The Business Planning & Operations (BPO) team within Data Management (DM) is responsible for ensuring the smooth running of our business through activities such as Quality & Compliance, Procedural Documentation Management, and Training and Learning. As the Associate Director, Quality and Compliance, you will ensure adherence to quality guidelines set by Health Authorities, address variances through waivers, CAPAs, and Quality Incidents, and maintain audit and inspection readiness. You will collaborate with the Data Management Leadership Team (DMLT) to ensure DM is always prepared for inspections or audits. This role requires proven experience in a quality team, a solid foundation in Data Management, and excellent industry GCP knowledge to lead CAPA and QI activities independently while coaching and mentoring supporting staff.

ACCOUNTABILITIES

• Develop, maintain, and improve processes, templates, and documentation related to quality and compliance management within DM.
• Serve as the point of contact for QI reporting and oversee the triaging and tracking of suspected quality issues within DM.
• Develop, implement, and maintain a Root Cause Analysis (RCA) and Corrective & Preventive Actions (CAPA) process to support all delivery models within DM.
• Collaborate with other BPO components for the rollout of the CAPA process.
• Liaise with team members where CAPA may impact existing processes or training.
• Deliver DM Quarterly QA reporting in collaboration with the Clinical Functional Partner.
• Ensure all QIs are captured, tracked, and closed with vendors/CROs, ensuring CAPA effectiveness before closure.
• Oversee all QIs and CAPAs assigned within VQV to DM, ensuring proper training according to AZ Policy and Procedures.
• Develop, implement, and maintain the process for managing all DM model quality changes.
• Ensure DM roles are trained and prepared for audits and inspections.
• Develop, implement, and maintain DM Model specific Mock Inspection Playbook/Inspection Readiness Toolkit.
• Establish yearly audit schedules with DMLT and oversee mock audits for high-profile studies.
• Assess quality issue reporting based on quality control activities and use risk management to evaluate compliance issues.
• Share findings from Mock Audits within BPO and beyond as required.
• Act as the POC within DM for regulatory inspections, ensuring all relevant parties are informed and prepared.
• Develop, implement, and maintain the process for DM eTMF compliance and report metrics to DMLT.
• Liaise with AZ QA and Alliance Management for all partnership-level agreements regarding quality management associated with DM.
• Assist with change management activities to ensure organizational compliance.
• Maintain awareness of changes in HA guidelines and ensure adherence across the DM organization.

ESSENTIAL SKILLS/EXPERIENCE

• Bachelor in scientific discipline or related field with a strong understanding of biomedical data and analytics. Advanced degree is a plus.
• Relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency.
• Experience as a project manager and subject matter expert of special initiatives supporting DM activities.
• Ability to work independently, under pressure meeting tight deadlines, demonstrating high level of initiative and flexibility.
• Excellent organizational and analytical skills.
• Strong technical and problem-solving skills with experience on computer systems for Data Management.
• Excellent understanding of clinical trial methodology, GCP, ICH, GCDMP and medical terminology.
• Experience with technologies and best practices across multiple platforms.
• Demonstrated experience to support complex projects and cross-functional teams including delivering to project and portfolio metrics.
• Excellent communication, interpersonal and negotiating skills in relating to colleagues and associates internal/external to the organization and leveraging those competencies to ensure continuous progress.
• Strong track record of building successful relations with supervisors, peers, suppliers, customers, partners and stakeholders is essential.
• Strong strategic experience and business analytics ability to distil research needs and define business, technical, and operational requirements.
• Team player.

DESIRABLE SKILLS/EXPERIENCE

• Experience in working with vendors.
• Experience in putting together storyboards.
• Experience implementing business processes.
• Experience in managing change.

Please refer the Job description for details