Join to apply for the Associate Director, Quality Control role at Alexion Pharmaceuticals, Inc.
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Join to apply for the Associate Director, Quality Control role at Alexion Pharmaceuticals, Inc.
Are you ready to lead a dynamic team in the world of Quality Control? As the Associate Director of QC, you'll be at the forefront of ensuring high performance and regulatory compliance within the ADMF Quality Control organization. This role demands operational leadership, inspection readiness, and a commitment to fostering a culture of empowerment and continuous improvement. Reporting to the Director of QC, you'll play a pivotal role in maintaining business continuity, adapting to new business needs, and embracing responsibilities beyond your original expertise. Flexibility and a growth mindset are key as you navigate the challenges of this exciting position!
Accountabilities
* 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 modeling Alexion’s values and behaviors.
* 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.
Essential Skills/Experience
* 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.
Desirable Skills/Experience
* A master’s degree or higher in Science, Pharmacy, or a related field.
At AstraZeneca's Alexion division, you'll find an environment where innovation thrives! Our commitment to rare diseases means your work will have a profound impact on patients' lives. With a rapidly expanding portfolio, you'll enjoy the entrepreneurial spirit of a leading biotech while being supported by exceptional leaders. Here, your career is not just a path but a journey to making a difference where it truly counts. Our culture celebrates diversity, innovation, and connection to patients' lived experiences. Join us in driving change with integrity!
Ready to make an impact? Apply now to join our team!
Date Posted
22-Jul-2025
Closing Date
04-Aug-2025
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.
Seniority level
* Seniority level
Director
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
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