ASSOCIATE DIRECTOR/RP MARKETING COMPANY OPERATIONS QUALITY

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

ACCOUNTABILITIES:

As an Associate Director/RP Marketing Company Operations Quality you will be involved in the design and execution of a common quality management system (QMS) and strategy for GMP and GDP activities across the Commercial Marketing Company (MC) for the AZ product portfolio in the country. You will report into the CEEBA Cluster Lead and be part of the Global Quality Organization.

ESSENTIAL SKILLS/EXPERIENCE:

• University degree in pharmacy.
• Experience in Bio/pharmaceutical industry within Quality or Pharmacovigilance space.
• Meeting the legal requirements to perform the role of a GDP Responsible Person under the Medicines Act (GDP)
• Experience in Bio/pharmaceutical industry within GMP/GDP environment.
• Demonstrated ability to work independently and in project settings to deliver objectives.
• Able to lead troubleshooting activities to resolve existing problems, make complicated judgements and anticipate future developments.
• Strong communication and influencing skills.
• Project and people management.
• Driving license cat B
  Join an environment of excellence, where we’re backed by a belief that good can always be better. It means we search for opportunities to add value. Harnessing science and evidence to foresee risk. A place to continuously innovate to find new and better ways to ensure we are improving outcomes for patients.
  Apply now to make a meaningful impact

• Provide leadership in alignment with regulatory and corporate requirements for Quality, GMP & GDP (Good Manufacturing and Good Distribution Practices) strategy and activities across the market as the Quality business partner to the Commercial leader.
• Responsible for Country specific regulatory requirements related to manufacture and distribution of AZ product in country, e.g. Release of product, resolution of Issue Management, recall administrator, training, management review, influence and decisions on local regulatory agency interactions, audits and inspection readiness and compliance to gain and maintain the AZ license to operate.
• Overseeing the handling, storage, and transportation of pharmaceutical products. Conducting regular audits and inspections of distribution facilities, processes, and documentation to identify and address any non-compliance issues.
• Accountable for local MCOQ Country specific activities related to, including but not limited to, resolution of Issue Management (post marketing surveillance e.g., Product quality and service and logistic, temperature excursion complaints, product security issues, influence and decisions on local regulatory agency interactions, as applicable.
• Responsible for assurance of compliance with standards for all local GMP & GDP activities. Define, develop, deploy and monitor the GMP/GDP policies, standards and procedures and execution in country market, being the primary point of contact.
• Responsible for ensuring QMS compliance, that risks are identified and escalated to Global Quality and achievement of country KPIs and objectives/Quality Plans, ensuring country trends are addressed through development of country continuous improvement plans.
• Supports global standardization, simplification and improvement of MCOQ Quality business processes and connecting the MC office to the broader Operations Quality, R&D and AZ External Quality organization.
• Represents Quality on cross-functional teams and steering committees related to MC.
• Lead working groups, teams, and projects to provide a global perspective and drive consistency and standardization in all matters related to quality and compliance.
• Responsible for MCOQ GMP&GDP input into divestments/acquisitions/licensing agreements/product launches in country.
• Ensures change management process is followed.
• Ensures vendor/supplier management based on risk assessment, audits, QAA and qualification to ongoing oversight helping to resolve issues as applicable.
• Ensure quality risk management process is followed, and active risk register maintained, as applicable.
• Promotes a Quality Culture in the MC, ensures GDP/GMP/QMS training is performed and that Job descriptions as applicable reflect requirements.
• Provides support to other MC in the CEEBA region.