The Associate Director, Development Supply Quality plays a pivotal role within Alexion’s Development Quality Assurance (DQA) organization. This individual provides strategic quality oversight to the Product Development Clinical Supply (PDCS) team, ensuring compliance with global GxP requirements—including Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Clinical Practices (GCP). The goal is to support the supply of safe, compliant, and effective clinical products for ongoing trials across diverse drug indications and product types.
This role requires close collaboration to ensure Alexion’s clinical programs are supported with quality, compliant finished products throughout their lifecycle, including biologics, combination products, gene and cell therapies, and other advanced modalities.
Your Key Responsibilities:
Strategic Quality Leadership:
- Provide strategic quality oversight to the PDCS team, aligning with Alexion’s mission and global GxP standards.
- Act as a Subject Matter Expert (SME) for GxP compliance related to clinical product supply, advising cross-functional teams on quality considerations.
- Develop and implement quality strategies to enable the successful global supply of clinical products.
- Lead quality activities across a diverse product portfolio, including biologics, combination products, gene and cell therapies, and advanced modalities.
- Lead quality-related activities such as deviations, risk management, change controls, procedural ownership, audit readiness, and inspection support.
- Mentor and train stakeholders and team members to foster a culture of quality excellence.
- Identify and implement opportunities to enhance quality systems and processes within clinical supply and across the DQA organization.
Oversight of Clinical Supply Activities:
- Oversee investigational product (IP) lifecycle management, ensuring GMP, GDP, and GCP compliance throughout clinical development. Responsibilities include pharmacy manuals, IP administration instructions, temperature excursions, and investigator site queries.
- Proactively identify and address compliance risks in clinical product storage, handling, and distribution.
Cross-Functional Collaboration:
- Partner with internal stakeholders to ensure seamless clinical supply execution and associated quality activities.
- Collaborate with external partners—including contract research organizations (CROs) and third-party logistics providers—to meet quality expectations.
- Represent Quality during audits, inspections, and regulatory interactions related to clinical supply.
- Work independently and collaboratively as both a leader and an individual contributor.
What You Need to Have:
- Bachelor’s degree in a relevant scientific or technical field (e.g., pharmacy, biology, chemistry, pharmaceutical sciences). Advanced degrees (e.g., Master’s, Ph.D.) are strongly preferred.
- 8+ years of experience in Quality Assurance or a related function within the biopharmaceutical industry, with a focus on clinical supply and product development.
- In-depth knowledge of GxP requirements (GMP, GDP, GCP) and their application to clinical supply and product development.
- Experience with diverse product types, including biologics, combination products, gene and cell therapies, and advanced modalities.
What We Would Prefer You to Have:
- Experience with audits (internal, supplier, or regulatory inspections) is an advantage.
- Familiarity with Quality Systems (e.g., TrackWise, Veeva Vault).
- Proven leadership in managing cross-functional teams or projects.
- Strong business acumen with a focus on collaboration and results delivery.
- Comprehensive understanding of quality systems and regulatory requirements for clinical supply.
- Exceptional problem-solving and risk management skills.
- Ability to influence and collaborate effectively with internal and external partners.
- Strong communication and presentation skills, with the ability to convey complex quality concepts clearly to diverse audiences.
- Excellent interpersonal skills and the ability to communicate effectively both verbally and in writing.
Date Posted
17-Jan-2025
Closing Date
30-Jan-2025Our 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.