Associate Director, Quality Control

Position Summary

The Associate Director (AD) of QC leads a large, multi-disciplinary team within the ADMF Quality Control organization, ensuring high performance, regulatory compliance, and effective execution of QC activities while supporting Lean and Digital transformations and strategic initiatives. Reporting to the Director of QC, this role is responsible for operational leadership, regulatory inspection readiness whilst promoting operational excellence, fostering a culture of empowerment and continuous improvement. Flexibility and a growth mindset are essential, as the role frequently requires adapting to new business needs and smoothly taking on responsibilities outside original areas of expertise. The AD serves as acting leader in the Director’s absence and is integral to maintaining business continuity.

Principal Responsibilities

• Responsible for the effective and compliant execution of all laboratory activities, ensuring that testing, documentation, and data integrity meet Alexion’s global standards while adhering to cGMP, corporate, and local regulatory requirements.
• Provides day-to-day operational management, resource planning, prioritization, and performance oversight of QC teams, with accountability for meeting site and corporate objectives and KPIs.
• Identifies and manages laboratory deviations, leads significant quality investigations, and oversees change controls and CAPAs, ensuring timely resolution and effective root cause analysis.
• Drives the collection, analysis, and reporting of Analytical Lifecycle Management (ALM) metrics and assures the quality and completeness of QC content for the Annual Product Quality Review (APQR).
• Acting as a subject matter expert for audits and inspections, the AD partners with internal and external stakeholders around regulatory submissions and queries, providing input and QC expertise for regulatory filings, site readiness, and ongoing inspection support.
• Proactively identifies process gaps and improvement opportunities, leading or supporting continuous improvement and digitalization projects, in line with Alexion’s operational excellence goals.
• Leads, coaches, and develops talent to ensure a skilled, agile, and engaged workforce, consistently modelling Alexion’s values and behaviours.
• The role contributes to longer-term QC organization strategy by supporting the Director in capacity planning, operating model evolution, and the introduction of innovative technologies or workflows.

Qualifications

• At least 10 years’ progressive experience in pharmaceutical or biopharmaceutical Quality Control or Analytical Operations, including direct leadership of laboratory teams in a cGMP environment.
• Proven track record in managing complex laboratory operations, resolving deviations/investigations, and supporting regulatory inspections and filings.
• Strong technical expertise in analytical methods and laboratory systems, with broad working knowledge of global regulatory expectations for pharmaceutical QC.
• Demonstrated experience driving change, leading improvement or transformation initiatives, and working collaboratively across functions or geographies.
• Highly developed communication, team leadership, and prioritization skills are essential.

Education

A minimum of a bachelor’s degree in Science, Pharmacy, or a related field is required; a master’s degree or higher is preferred.

Date Posted

19-Feb-2026

Closing Date

27-Feb-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.