Marketing Company Operations Quality Associate Director

Job Description / Capsule

• Leads and directs the Quality Management System within the Joint Venture Entity - AAPI.
• 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 organization operating under One AZ QMS.
• Accountable for compliance with all relevant Acts and Regulations.
• Accountable and responsible for quality management of local suppliers.
• This position is based in Algiers - Algeria.

Typical Accountabilities

• Maintain and update local Quality Management System (QMS) in alignment with AstraZeneca PQS and local regulations, to cover GMP/GDP activities related to AAPI scope.
• Ensure effectiveness of the QMS across GMP/GDP areas in accordance with AstraZeneca Standards and local regulations.
• Ensure that all functional QMS elements are in place, as described the MCOQ Quality Manual.
• Monitor and report key quality metrics to senior management to assure the effective deployment of the quality system.
• Responsible for coordination of Quality Management reviews across GxP functions in the JV.
• Align with AstraZeneca Strategy for local execution in term of AAPI Quality system.
• Management of local suppliers’ quality management with direct participation, covering the whole supplier lifecycle.
• Perform local suppliers’ audits and report supplier’s quality risk assessment.
• Participate in the ESM meetings (Operational review / S&OP meeting, Supplier Performance Review meeting) and Mkt Access External Ops Team Review.
• Assure appropriate records management and record retention practices are being employed within the CMOs sites.
• Interface directly and work closely with External Quality Team and local regulatory team in relation with CMOs/Manufacturing sites to:
  • Ensure active participation on global Quality initiatives from a strategic GMP compliance perspective.
  • Ensure product quality and patient safety prior batch release to market.
• Collaborate closely with CMOs representatives to ensure reliable supply of relevant commercial products.
• Identify trends and communicate identified risks and related mitigation actions.
• Ensure Continuous Improvement by:
  • Strive to continuously improve the established ways of working.
  • Monitor KPIs related to QMS and propose remedial & Improvement actions through continuous improvement plan.
• Perform periodic self-inspections.
• Handle and manage local change controls and impact assessment of global change controls.
• Supports local AAPI 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.
•   Manage GQA audits and local inspections.
•   Manage product quality complaints (PQC) and recalls.
• Provide training, supporting and coaching structure for Quality roles.
• Ensures adherence to Quality, Health and Safety, Good Manufacturing Practice, Good Distribution Practice and regulatory requirements of own work and others work.
• 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 AAPI JV 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

Education, Qualifications, Skills and Experience

Essential

• Bachelor's degree or greater in Sciences, Pharmacy or Engineering.
• Experience in Compliance /Quality Assurance within a pharmaceutical Manufacturing environment.
• More than 10 years of experience with increasing levels of responsibility within quality management.
• Ability to Travel.

Desirable

• Multi-sites management experience across a global network.
• Ability to manage significant risk and apply solid judgement in high pressure situations.
• Managerial experience in supply chain management of a pharmaceutical company
• Time management and planning skills
• Excellent written and verbal communication skills in English
• Strong interpersonal skills with a customer relationship and rapport focus
• Uncompromising attention to detail and accuracy
• Ability to work independently in a high pressurized environment.

Key Relationships to reach solutions

Internal (to AZ or team)

• Cross functional Team (Local & Global).
• Local Regulatory Affairs Team.
• MCOQ Team.
• ESM Team.
• EQ (External Quality Team).

External (to AZ)

• CMOs Representatives (Quality Team).
• Suppliers Representatives (Quality Team).
• Regulatory Agencies.

Date Posted

Closing Date

AstraZeneca 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 comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.