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Sr. Director, Commissioning, Qualification & Validation (CQV)

Employer
Moderna, Inc.
Location
Norwood, MA
Start date
Nov 22, 2023

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Job Details

The Role:

Reporting to the Senior Vice President Facilities and Engineering, the Sr. Director for Global CQV will lead the Commissioning, Qualification and Validation Program for Global Capital Projects and CQV Program implementations at Moderna Global Facilities. The candidate will lead a team of CQV FTEs and/or contractors supporting Capital Projects and CQV Global Program and Disciplines throughout the Moderna global footprint for Commercial Drug Substance and Drug Product operations. Additionally, the candidate will also play an active role in providing guidance to cross-functional teams to establish and maintain a Global CQV Program, including Equipment CQV, Shipping Validation and Cleaning Validation for GMP and GLP assets, as well as Engineering lifecycle deliverables, continuous improvements initiatives and drive quality standards and compliance.

Travel to support CQV activities could be up to 20% at critical project phases.

Heres What Youll Do:

  • Lead/Build/Develop and implement executable CQV Global strategies, policies, and procedures to ensure compliance with regulatory requirements, industry standards, and best practices.

  • Manage a cross-functional team of FTEs and/or contractors in alignment with Moderna values and culture.

  • Lead CQV master schedules and planning activities for capital projects and programs within the global Moderna determining scope, risk-based approach, and timelines considerations while working with cross-functional teams.

  • Provide subject matter expert 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).

  • Provide technical leadership and guidance on CQV activities, including equipment qualification, process validation, cleaning validation, shipping validation and computer system validation.

  • Translate the business needs of the company into engineering solutions and develop CQV strategies.

  • Negotiate and Influence in support of the Facilities and Engineering Organization with cross-functional stakeholders at Senior Leadership Level.

  • Lead and support inspection readiness and health regulatory audits for CQV scope.

  • Benchmark internally and externally to investigate and recommend such strategies.

  • Drive results by owning and completing 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.

  • Provide strategic direction and leadership 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.

  • Oversee 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.

  • Oversee the validation activities related to DS and DP manufacturing processes, equipment, and systems to ensure compliance with regulatory requirements and quality standards.

  • Partner with the Global Digital CSV team to create and maintain an integrated CQV and CSV approach for DS and DP manufacturing automated and process control integrated equipment/systems.

  • Drive continuous improvement initiatives, identifying opportunities for efficiency and effectiveness in CQV processes.

  • Ensure staff are adequately trained and competent in CQV activities, fostering a culture of quality and compliance.

  • Stay updated with industry trends, regulatory changes, and best practices in CQV, ensuring the organization's practices remain compliant and competitive

  • 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 Bring to the Table:

  • B.S. in Engineering. B.S. degrees in other scientific or health-related fields will be considered.

  • Minimum of 18 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. Must be able to be able to find true root cause and path forward for complex problems.

  • Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required.

  • Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his / her manager.

  • 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!

About Moderna

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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

#LI-AG1

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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Telephone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States

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