The Role
Reporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance 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 execution of an end-to-end project quality plan, which includes regulatory inspection readiness. The leader will liaise with key stakeholders to work through the facility integration strategy in addition to ensuring the appropriate quality 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 quality oversight for drug product operations to ensure compliance with cGMPs, company procedures, and regulatory requirements.
The Associate Director 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:
- Establish robust operational readiness plans to transition from the construction phase to full-scale production, ensuring all systems and processes are in place for cGMP compliance,
- Develop, lead, and manage the execution of a project quality plan. Ensure the plan embeds an audit readiness component which factors all potential risks/mitigations associated with the project (i.e. facility, processes, personnel etc.) to ensure a successful pre-approval inspection.
- Oversee the hiring, training, and development of a high-performing Quality Operations team capable of providing Quality oversight across multiple Drug Product filling lines,
- Develop and implement operational and quality systems (i.e. deviation / change management, batch record management, cleaning & disinfection, personnel training, etc.) ensuring Quality 4.0 / Pharma 4.0 principles are embedded into their design.
- Collaborate with cross-functional teams working in a highly matrixed environment to drive decisions and influence outcomes to enable Moderna’s clinical pipeline,
- Ensure a detailed lesson learned is executed, documented, and disseminated to respective personnel upon project closure.
- Develop and track performance of quality and operational process readiness against pre-defined milestones – report on progress, risks, escalation, and resolution of issues through governance channels, where needed.
- Provide expert guidance and support while managing interfaces with key business stakeholders for quality and operational processes.
- Provide leadership to ensure a ‘Right-First-Time’ and mature quality culture is developed and maintained within the project leading to a successful PAI outcome.
- Support/lead troubleshooting of complex issues encountered during CQV activities. In addition, provide support for CQV deviations and change management teams.
- Represent quality in cross-functional project meetings; recruit, develop and lead personnel to ensure department and project objectives are met (i.e. quality, safety, cost).
- Ensure timely resolution and/or escalation of quality issues to senior management.
- In collaboration with quality system business process owners and site quality operations teams, support the development of policies and procedures in the evolution and continuous improvement initiatives of the Global Quality Management System.
- In partnership with the Digital team, identify and implement tools and electronic Quality systems to improve processes.
- Lead risk management activities to identify potential operational issues and implement mitigation strategies,
- Ensure adherence to all environmental, health, and safety guidelines, promoting a culture of safety within the operations team,
- Establish key performance indicators (KPIs) to measure and report on operational performance, making data-driven decisions to optimize processes,
- Foster a culture of innovation and collaboration, encouraging team members to contribute ideas for process improvements and operational excellence,
- Serve as the primary point of contact for operations during regulatory inspections and audits,
- Drive continuous improvement initiatives to enhance operational efficiency, reduce costs, and improve product quality,
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 in aseptic drug product manufacturing, with at least 3 years in a leadership role.
- Problem-solving mindset with a commitment to quality and safety.
- In-depth knowledge of cGMP regulations, aseptic processing, and cleanroom operations.
- Strong leadership skills with the ability to develop and motivate a diverse team.
- Excellent project management, organizational, and communication skills.
- Demonstrated ability to work cross-functionally and manage complex projects with multiple stakeholders, with the ability to convey complex information in an understandable manner to various stakeholders.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
- Proven track record of successful facility start-ups or major operational projects (e.g. Greenfield or Brownfield Projects) within the pharmaceutical industry.
- Experience with budget management and cost optimization in a manufacturing environment.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
- Vacation, sick time and holidays
- Volunteer time to participate within your community
- Discretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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