Associate Director Marketing Company Operations Quality at AstraZeneca

Typical accountabilities will include

• Responsible for overseeing the implementation and delivery of a common Quality system and strategy for GMP and GDP activities across in Commercial marketing company for all AZ product portfolio in South Africa (SA), Sub-Saharan Africa (SSA), French Speaking Africa (SSA) Marketing Company (MC). 
• Executes country strategy for Affiliate Quality and Marketing Company GMP/GDP aligned with AZ’s 2030 bold ambition strategy for market expansion, product launches and accessibility. 
• Accountable for assurance of quality compliance with worldwide standards for all local GMP & GDP activities and connects the affiliate offices the broader Operations Quality and R&D organisation operating under One AZ QMS.  
• Accountable for compliance with all relevant Acts and Regulations.

Job Description

• For South Africa, develop, support and drive excellence in Affiliate GMP&GDP Quality activities to maintain the local License to Operate.  
• Primary point of GMP&GDP contact for the country and maintaining an effective governance structure to ensure oversight of quality activities. 
• Responsible for QMS implementation in SA and SSA & FSA MC.
• Provides leadership for GMP & GDP (Good Manufacturing and Good Distribution Practice) strategy and activities in the SA/SSA/FSA MC.
• Responsible for the coordination of Quality Management reviews across GxP functions for South Africa and SSA&FSA MC.
• Represents Quality on cross-functional and cross SET teams and steering committees related to Affiliate market.
• Drive global standardisation, simplification and improvement of South Africa and SSA&FSA Quality Management processes. 
• Provide training, supporting and coaching structure for Quality roles.
• Is the primary point of expertise for GMP & GDP activities impacting the South Africa and SSA&FSA MC organizations.
• Responsible for budget planning and adherence to budget for the Country, South Africa & SSA& FSA MC.
• Responsible for promoting Quality Culture across AstraZeneca South Africa and SSA&FSA MC organizations.
• Accountable for compliance assurance and working to one set of GMP & GDP standards and processes, as well as common GxP process across the Affiliate GxPs within the MC.
• Accountable for compliance to Country specific quality and regulatory requirements related to manufacture and distribution of AZ product in country, including but not limited to release of product batches, resolution of Issue Management, recalls, influence decisions on local regulatory agency interactions, audits and inspection readiness and compliance to gain and maintain AZ licence to operate.
• Demonstrated ability to work independently and in project settings to deliver objectives.
• Keeps own knowledge of best practices, industry standards and new developments in quality management up to date.
• Employs prepared information to discuss, plan and help carry out improvement plans, priority setting, investigation reports, quality or performance improvement recommendations.
• Ensures adherence to Quality, Health and Safety, Good Manufacturing Practice, Good Distribution Practice and regulatory requirements of own work and others work.
• Responsible for ensuring that policies and standards meet regulatory requirements.
• Carries out compliance reviews and reporting for external suppliers including issue resolution with senior management and AZ site/MC leaders, this may include, but is not limited to, the review and approval of investigation reports and participation in issue management teams.
• Supports local SA, SSA & FSA MC to deliver the license to operate, including but not limited to support for GMP&GDP audits and inspections, implementation of effective self-assessment programs.
• Responsible for the achievement of country KPIs and objectives/Quality Plans. Ensure country trends are addressed through development of country continuous improvement plans.
• Contributes to development local procedures due to specific local regulatory requirements and provides some technical input into the development of global procedures and standards.
• Proactively looks for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring appropriate level of compliance

ESSENTIAL SKILLS & EXPERIENCE REQUIRED

• Completed Bachelor of Pharmacy Degree and registration with the South African Pharmacy Council
• Minimum 5 years’ experience as Responsible Pharmacist
• Appropriate cross functional collation with key stakeholders at the MC-Regulatory/Patient Safety/Medical Information/ Key Account Managers/ Marketing/ Supply/ QA Pharmacist
• Appropriate cross functional collation with Ops Distribution Country Leadership Team
• Strong communication and influencing skills with accuracy and attention to detail
• Project and people management
• Fluency in English is required.
• Must be open to travel when necessary.