https://amzn.to/44P6GXZ
The Role
Reporting to the Executive Director, Clinical and Development Quality, the Sr. Director/Director of Quality Engineering based in Norwood, MA, you will be responsible for ensuring the highest standards of quality and compliance in Validation, tech transfer, digital systems, and facilities and engineering at the Norwood Campus. You will lead a team of quality engineers and collaborate with cross-functional teams to establish and maintain quality standards, drive continuous improvement initiatives, and ensure regulatory compliance.
Here’s What You’ll Do:
Provide strategic direction and leadership for the quality engineering function, aligning it with the overall business objectives of the organization.
Develop and implement quality engineering strategies, policies, and procedures to ensure compliance with regulatory requirements, industry standards, and best practices.
Foster a culture of quality excellence and continuous improvement within the quality engineering team and across the organization.
Implement and maintain an effective quality management system (QMS) to ensure compliance with relevant regulations, including Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Oversee the development and execution of quality plans, risk assessments, and validation strategies for manufacturing processes and equipment.
Drive investigations into quality issues, deviations, and non-conformances, and ensure appropriate corrective and preventive actions are identified and implemented.
Oversee the validation activities related to manufacturing processes, equipment, and systems to ensure compliance with regulatory requirements and quality standards.
Develop and implement validation strategies, protocols, and procedures for critical processes and equipment used in the manufacturing of mRNA therapeutics.
Lead validation activities, including protocol development, execution, and documentation, as well as the analysis and interpretation of validation data.
Working with the Global CSV team, maintain a comprehensive computer system validation (CSV) program to ensure the integrity and reliability of computerized systems used in the Norwood manufacturing facility.
Collaborate with IT, F&E, and Digital to leverage AI and machine learning to support predictive maintenance, anomaly detection, and risk assessment.
To ensure that computerized systems are designed, implemented, and maintained in compliance with regulatory expectations and best practices.
F&E and Digital to leverage AI and machine learning in support of predictive maintenance, anomaly detection, and risk assessment.
Provide quality oversight and guidance for the tech transfer process of mRNA therapeutics from research and development to clinical drug substance and clinical drug product manufacturing.
Review and assess tech transfer protocols, plans, and reports to ensure compliance with regulatory requirements, quality standards, and best practices.
Provide quality oversight for the facilities and infrastructure within the mRNA manufacturing facility, ensuring compliance with regulatory requirements, industry standards, and best practices.
Establish and maintain a comprehensive facilities quality program, including the development and implementation of policies, procedures, and guidelines.
Here’s What You’ll Bring to the Table:
Bachelor’s degree with 15-20 years of experience in progressive multi-functional leadership roles with a preference for that experience to have been in the biotechnology or vaccines companies.
Excellent analytical, problem-solving, and decision-making skills.
Quality Assurance, operations, process engineering, development, and tech transfer experience preferred.
Comprehensive knowledge of global cGMP regulations, guidance, and industry standards.
Superior customer service mindset with excellent interpersonal and communication skills
Biased to reduce complexity and create simple and organized data systems
Desire and interest to leverage new technology and innovative information management tools
Demonstrated problem detection and problem resolution skills
Demonstrated people leadership skills with a passion for talent development.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit (url removed).
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at (url removed). (EEO/AAP Employer)
–
Who Are We?Taking care of our customers, our communities and each other. That’s the Travelers Promise. By honoring this commitment,...
Apply For This JobJob Description: At Warner Music Group, we’re a global collective of music makers and music lovers, tech innovators and inspired...
Apply For This JobWho We Are: iAnthus Capital Management is a multi-state operator, encompassing the full spectrum of cannabis enterprises, from cultivation to...
Apply For This JobClinical Care Coordinator (Remote) Are you an experienced Clinical Care Coordinator looking for a new challenge? Do you value care...
Apply For This JobWant to learn more about this role and Jobot? Click our Jobot logo and follow our LinkedIn page! Job details...
Apply For This JobWe are working a NYC Based global technology company on a new Director, Finance opening. Our client has a patented...
Apply For This Job