Associate Director, Quality Control

3 months ago

Oxford, United Kingdom Moderna Full time

**The Role**:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

Moderna is expanding its innovative reach in Harwell, UK, a leading center for scientific research and development. Our state-of-the-art manufacturing site here plays a critical role in advancing our mission of delivering mRNA medicines globally. We invite committed professionals to join our Harwell team and contribute to groundbreaking medical advancements.

A position of great responsibility and impact, the Associate Director for Quality Control at our Harwell manufacturing site is crucial in overseeing the commercial testing functions within the Quality Control department. This role supports raw materials and drug substances testing for mRNA products, encompassing Microbiological and Environmental Monitoring (EM) tests, and extends to method transfer, qualification, and validation activities.

**Here's What You’ll Do**:
Within 3 Months, You Will

Gain a comprehensive understanding of Moderna's Quality Control processes and standards, specifically focusing on the nuances of commercial testing functions for mRNA products. This includes familiarization with testing procedures for raw materials, drug substances, Microbiological and EM tests.

Begin actively overseeing the daily operations of the Quality Control commercial program. This will involve directly managing functions related to stability testing, ensuring that all testing is conducted in line with Moderna’s high standards and regulatory compliance.

Start leading the Quality Control laboratory team, getting to know each team member, their specific roles, and functions. This period will include establishing clear communication channels, understanding individual capabilities and areas of expertise, and setting preliminary objectives for the team.

Within 6 Months, You Will

Implement Lean methodologies within the Quality Control department. This will involve analyzing current processes, identifying areas for efficiency improvements, and suggesting changes that could enhance the overall productivity and effectiveness of testing functions.

Take a lead role in the development and updating of Standard Operating Procedures (SOPs) and laboratory data collection & documentation systems, both paper and electronic. This task will be aimed at ensuring all procedures align with current cGMP compliance requirements.

Begin extensive collaboration with other critical departments, including Analytical Sciences & Technology (AS&T), Global QC, External QC, Quality Assurance, and Regulatory Affairs. These collaborations will focus on supporting drug substance and product testing both internally and at Contract Manufacturing Organizations (CMOs), as well as other quality-related information for stability programs and Annual Product Quality Reviews (APQR).

Within 12 Months, You Will

Become fully integrated into your role, leading the Quality Control team with effectiveness and confidence. This will involve ongoing management and mentoring of laboratory personnel, fostering their career development and ensuring the team is meeting all performance and quality targets.

Play a pivotal role in overseeing and managing laboratory investigations, change controls, and Corrective and Preventative Actions (CAPAs) related to Quality Control operations. This includes ensuring all QC operations are compliant with relevant regulatory and company standards.

Lead method transfer and qualification activities in close collaboration with AS&T and development groups. This will involve overseeing the transfer of new methods into the QC laboratory, ensuring all methods are robust, validated, and fit for purpose.

Make significant contributions to the budget planning and resource allocation for the QC department, aligning with Moderna’s strategic goals and ensuring efficient use of resources.

Provide essential support during health authority, internal/external, and vendor audits. This includes interfacing with health authorities during site and external inspections, ensuring that the QC department adheres to all relevant FDA, EU, ICH guidelines, and regulations, and demonstrating Moderna’s commitment to maintaining high-quality standards in all operations.

**Here’s What You’ll Bring to the Table**:
**Minimum education required**: Bachelor’s Degree in a relevant scientific discipline.

**Minimum experience required**: 10 + years in applied industry experience; 4-6 y

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