Sr. Manager, Validation, Drug Product

The Role

Reporting to the Associate Director, Validation the Sr. Manager, Validation is responsible for leading Validation readiness for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility.  This role involves ensuring operational readiness for production of both clinical and commercial drug products while adhering to current GxP, corporate, regulatory and industry best practices. The role is responsible for providing cross functional support for Commissioning, Qualification & Validation (CQV) activities which occur as part of the facility start up. 

The objective of this role includes the development and execution of a comprehensive validation strategy including regulatory inspection readiness. The leader will liaise with key stakeholders to work through the facility integration strategy in addition to ensuring the appropriate systems and operational processes are developed, implemented, and maintained to ensure the seamless start-up and routine operation of the facility.  

Upon facility start-up this role will provide end-to-end Validation oversight for drug product operations to ensure compliance with cGMPs, company procedures, and regulatory requirements.

The Sr. Manager will play a crucial role in establishing the operational strategy, implementing best practices, and building a team to achieve excellence in manufacturing operations while adhering to regulatory compliance and quality standards. You will be at the forefront of our mission to deliver mRNA therapies to patients worldwide, using your expertise to ensure the smooth operation of our manufacturing processes. Your work will directly contribute to the production of therapies that have the potential to transform the lives of patients.

Here’s What You’ll Do

In this role, your responsibilities will include:

• Supervise and lead Validation Engineers (FTEs and/or Contractors) responsible for the commissioning, qualification, and validation of facilities, utilities, equipment, and critical processes for Drug Product Manufacturing at Moderna’s Norwood MTC Campus.

• Develop and execute validation plans for facility utilities, equipment, and processes, including formulation, clean component preparation, filling, visual inspection, and packaging.

• Prepare and review validation documentation, including protocols, reports, and Standard Operating Procedures (SOPs).

• Coordinate and perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.

• Serve as Validation System Owner for validation systems and hardware. Develop and improve maintenance strategies for validation hardware.

• Work closely with cross-functional teams to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and industry standards.

• Investigate and troubleshoot validation-related issues and implement corrective and preventive actions (CAPA).  Ensures timely resolution of documentation, compliance, product complaints, and quality deviation investigations.

• Maintain validation status of systems and equipment through periodic reviews and revalidation activities.

• Support risk assessments and change control processes related to facilities and engineering.

• Provide technical expertise and training to other team members and departments on validation principles and practices.

• Collaborate with project teams on the integration of new technologies and equipment into the production environment.

• Ensure timely completion of validation activities in line with project timelines and production schedules.

• Own quality records or actions within quality systems (i.e. Change Controls, Deviations, and CAPAs) related to validation activities. Provide input into assessing change controls, and continuous improvement initiatives.

Here’s What You’ll Need (Minimum Qualifications)

• Bachelor of Science degree in Engineering, Pharmaceutical Sciences, or a related technology discipline.

• A minimum of 8 years of experience with at least 2 years in drug product manufacturing.

• In-depth knowledge of cGMP, FDA, and regulations, pharmaceutical processing, and cleanroom operations.

• Experience with validation of utilities, formulation, filling, visual inspection, and packaging systems.

• Excellent written and verbal communication skills, with the ability to prepare clear and concise validation documentation.

• Strong problem-solving abilities and attention to detail.

• Ability to work independently and as part of a team in a fast-paced and changing environment.

• Proficient in Microsoft Office Suite and validation management software.<