Sr. Manager - Quality Assurance, Systems and Compliance

Pay Rate: 65-75 per hour

Norwood, MA

6 month contract

The Role

This role is an exciting opportunity to be a part of the Quality Assurance organization. Moderna is a growing organization with a state-of-the-art cGMP manufacturing facility in Norwood, MA, USA. The site focuses on manufacturing early phase and commercial product. As the company grows, the Quality Assurance is looking for talented individuals with a strong Quality Culture mindset and ability to adapt to a fast-paced environment. This role will be supporting many of the responsibilities listed below and will be expected to collaborate with cross-functional departments to maintain and enhance compliance at the Norwood site.

We work collaboratively as a team, we boldly strive for excellence, we are constantly curious and committed to ongoing learning and improvement, and we are relentless in our pursuit of having the highest level of Quality products.

Here’s What You’ll Do

• Manage the performance and effectiveness of the quality system programs such as risk management, change management, discrepancy and CAPA management, training, documentation and records management, and data integrity via maintenance and execution of Quality Management Review and Site Quality Council governance forums.

• Support the establishment and reporting of quality metrics for cGMP related functional areas.

• Author and review SOPs and Policies to ensure compliance and adherence to regulations/cGMP operations.

• Author, review, and approve Annual Product Quality Reviews (APQR) and other trend reports.

• Partner cross-functionally to maintain a company culture that embraces compliance and recognizes that compliance is a collective responsibility of all company employees.

• Continue to improve Moderna’s overall Quality Management System (QMS) and quality manual, policies and procedures while keeping them current with emerging and changing regulations, guidance documents and current industry best practices and expectations.

• Provide compliance guidance and training through various methods including formal and informal presentations and trainings.

• Identify opportunities for quality system improvements.

• Work collaboratively with the digital team on the GXP integrated digital landscape to support eDOC, eQMS, and LMS systems.

Within 3 Months, You Will…

• Complete required onboarding and training programs, familiarize with company policies, procedures, and quality systems.

• Start developing relationships with key stakeholders.

• Understand the current state of compliance and quality systems.

Within 6 Months, You Will…

• Participate in development of strategic plans for quality system and compliance improvements.

• Establish regular communication channels for updates and feedback.

• Fully own coordination and execution of Quality Management Review and Site Quality Council meetings.

Within 12 Months, You Will…

• Act autonomously to identify compliance risk and continuous improvement opportunities.

• Demonstrate tangible improvements in quality systems and compliance metrics, establish yourself as an influencer within the organization, and contribute to broader organizational goals and initiatives beyond the quality systems and compliance realms.

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

• Bachelor’s degree with a minimum of 10 years of experience in the pharmaceutical industries providing Quality Assurance oversight in a cGMP organization.

• Fluent in written and spoken English.

• Experience in data analysis, statistical evaluation, and trending of data.

• Ability to think critically and demonstrate troubleshooting and problem-solving skills.

• Understanding and experience with global cGMP regulations (e.g. FDA, MHRA, EMA, PMDA, ANVISA) and ICH guidelines.

• Ability to interact effectively with all levels of personnel within the organization.

• Ability to navigate through ambiguity and rapid growth and adapt to change.

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Master’s degree with a minimum of 8 years of experience in the pharmaceutical industries or Ph.D. with a minimum of 5 years of experience in the pharmaceutical industries providing Quality Assurance oversight in a cGMP organization.

• Deep understanding and experience with global cGMP regulations (e.g. FDA, MHRA, EMA, PMDA, ANVISA) and ICH guidelines.

• Advanced experience in data analysis, statistical evaluation, and trending of data.

• Capability to lead and train a diverse, multinational community of practice with multiple stakeholders.

• Proven ability to lead and manage projects/teams of significant scope and complexity, meeting deliverables and timelines (project management skills).