Global Quality Manager MCOQ US Quality Manager

This position will ensure excellence in Marketing Company GMP & GDP Quality activities to maintain the local License to Operate (LTO) driving compliance quality performance and continuous improvement across the US market and aligned cluster.

Key Responsibilities

• Governance and Leadership

  • Serve as back-up to the Cluster Lead as the GMP/GDP contact for the region. Maintain an effective governance structure that provides transparent oversight of quality activities and risk management.

  • Act as a core member of the Marketing Company Quality Regional Leadership Team contributing to strategy prioritization and resource planning.

  • Lead manage and develop team members in a multi-layered organization; set objectives and build capabilities to deliver against global processes and local needs.
    

• Strategy Policy and Quality System Execution

  • Collaborate with the US Cluster to define and deploy the GMP & GDP strategy across markets and the commercial SET area partnering with Commercial SET leaders Regional Commercial Heads and Global Patient Safety.

  • Shape and execute the Marketing Company GMP/GDP Quality System and framework including change control quality events CAPA oversight deviation/incident management and documentation practices.

  • Define implement and monitor GMP/GDP policies and standards in market; drive global standardization simplification and continuous improvement of Marketing Company Quality processes.
    

• Management Review Performance and Reporting

  • Support the Marketing Company Quality Management Review (QMR) process including preparation execution and escalation to Operations Commercial and R&D senior leadership and SET members.

  • Contribute to compliance and performance reporting to AstraZeneca Operations Leadership for Marketing Company Quality metrics and insights.

  • Support budget planning and management for the Marketing Company Quality organization.
    

• Regulatory Compliance and Inspection Readiness

  • Maintain current knowledge of country-specific regulatory requirements for manufacturing and distribution; ensure audit/inspection readiness and compliance to sustain AZs LTO.

  • Lead/oversee resolution of Issue Management FARs BPDRs recalls and regulatory interactions as appropriate ensuring timely and compliant outcomes.
    

• US Product Quality Complaints (PQC) Leadership

  • Act as Regional Process Champion for the PQC process.

  • Oversee end-to-end US PQC intake triage and communication to supply sites ensuring consistent clear and timely reporting aligned with AZ policies.

  • Integrate across stakeholders (MCOQ Regional Process Network US Operations US Patient Safety global supply sites) to ensure awareness of new programs and drive customer feedback into supply and functional teams.

  • Partner with the AZ Information Center (AZIC) to maintain an accurate comprehensive knowledge base aligned to US PQC policies.

  • Collaborate with the Vendor Management Team to monitor IQVIA performance (e.g. weekly quality checks) identify opportunities and drive improvements.

  • Support projects pilots and initiatives aligned to supply site US Operations and US Commercial goals.

  • Support and participate in internal audits and external regulatory inspections of the US PQC process.

  • Provide oversight for Drug Quality MedWatch reports from FDA in accordance with local requirements.

  • Stay current with evolving US regulatory requirements and best practices related to PQCs.
    

• People and Capability

  • Provide training support and coaching on GMP/GDP requirements and practices to Marketing Company personnel.

  • Contribute to integration activities for divestments acquisitions and licensing agreements by providing Marketing Company GMP/GDP quality input for the region.

Essential Qualifications

• Qualified to degree level (Bachelors) preferably in a science /
  technical field such as Pharmacy Biology Chemistry or Engineering

• Minimum of 7 years in Operations or Quality Assurance within either the pharmaceutical industry Biopharma or medical device industries .

• Demonstrated strong level knowledge of GMP/GDP quality management processes. Key focus area on Complaint Management skills.

• Ability to support delivery near and longer term of Marketing Company GMP/GDP strategy across market in AZ Commercial network and partners.

• Excellent communication and organization skills with ability to make decisions and influence outcomes related to patient supply and AZ reputation.

• Strong business acumen with Integrity and high ethical standards. Ensures AstraZenecas license to operate for GMP/GDP through development and delivery of effective strategies for GMP/GDP in local marketing companies.

• A broad understanding of the technical requirements within Quality and an ability to balance this with industry standards to achieve business goals

• Ability to develop training materials and support coaching and training for team.

• Proven leadership skills

• Demonstrated ability to work independently and effectively in a cross-functional team environment with ability to work across cultures.

• Demonstrated ability to manage multiple competing assignments and timelines.

• Excellent communication skills both oral and written.

• Demonstrated ability to influence whilst maintaining independent and objective views.

• Demonstrates ability to maintain high ethical standards including a commitment to organization values and behaviors.
  

Desirable Qualifications

• Line management experience

• Post-graduate degree
  

Bring your expertise to a role that safeguards ourLicense to Operate elevatesGMP/GDP excellence and acceleratescontinuous improvementso patients partners and regulators trust every step we take across the US and beyond. Ready to lead quality performance that sets the benchmark

Apply today!

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.