Reporting to the Associate Director of Global CQV, the Associate Director for CQV will support the Commissioning, Qualification and Validation efforts for the Commercial Individualized Neoantigen therapy INT Facility at Marlborough, MA. The candidate will manage a team of CQV FTEs and/or contractors supporting the Capital Project Delivery Model. The candidate will establish and maintain the Global CQV Program as well as Engineering lifecycle deliverables, continuous improvements initiatives and drive quality standards and compliance at the Commercial INT Site ensuring a robust validation package and regulatory compliance and audit readiness at all times.
Travel to support CQV activities could be up to 15% at critical project phases, specifically Factory Acceptance tests executions.
Heres What Youll Do
Develop and support the implementation of CQV Global strategies, policies, and procedures to ensure compliance with regulatory requirements, industry standards, and best practices at the commercial INT Facility.
Manage a cross-functional team of FTEs and/or contractors in alignment with Moderna values and culture.
Support CQV master schedules and planning activities for commercial INT capital project and programs determining scope, risk-based approach, and timelines considerations while working with cross-functional teams.
Provide input and direction/guidance to all CQV lifecycle deliverables (i.e., user requirements, design specifications, process parameters, FMEA assessments, System risk assessments, Qualification and Validation protocols, etc).
Translate the business needs of the company into engineering solutions and develop CQV strategies.
Support in benchmarking internally and externally to investigate and recommend such strategies.
Contribute to the successful completion of CQV capital projects and meeting the project timelines to ensure the schedule is not impacted.
The candidate must be able to drive results on multiple complex assignments simultaneously, in addition to reviewing and guiding the work and performance of FTEs and contractors.
Support the strategic direction for the CQV Global Org, aligning it with the overall business objectives of the F&E organization.
Foster a culture of good engineering practices, quality excellence and continuous improvement within the F&E team and across the organization.
Support the development and execution of qualification & validation master plans, risk assessments, and validation strategies for manufacturing processes and equipment.
Support CQV quality records and ensure appropriate corrective and preventive actions are identified and implemented.
Support the validation activities related to Facilities, Utilities, DS and DP manufacturing processes, equipment, and systems to ensure compliance with regulatory requirements and quality standards.
Partner with the Global CSV team to create and maintain an integrated CQV and CSV approach for DS and DP manufacturing automated and process control integrated equipment/systems.
Collaborate with F&E and Digital to leverage AI and machine learning to support predictive maintenance, anomaly detection, and risk assessment.
Other responsibilities per Capital Project requirements and needs.
Heres What Youll Need (Minimum Qualifications)
B.S. in Engineering. B.S. degrees in other scientific or health-related fields will be considered.
Minimum of 10 years in commissioning / qualification / validation experience in cGMP manufacturing environments.
Proven experience leading Teams prior supervisory experience required.
Strong understanding of validation principles including but not limited to facilities, utilities, equipment, and systems (FUSE).
Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection.
Must be able use technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions.
Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers. Technical writing skills required.
Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.
Ability to represent Modernas interests, objectives, and policies in a professional and responsible manner.
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!
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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.
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. Were 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 email@example.com. (EEO/AAP Employer)