Global Inspection Management Director

Location
Norwood, MA
Posted
May 08, 2022
Ref
R7664
Required Education
Bachelors Degree
Position Type
Full time

The Role:

Reporting to the Sr Director, Global Quality Compliance, the Director Global Inspection Management will be responsible for global inspection management process and strategy. The individual will be responsible for defining approaches and ensuring the design of the inspection program effectively advances the global strategies for sustainable compliance.  Additionally, the individual we preemptively monitor and communicate quality compliance performance indicators regarding inspections to the leadership team.

The individual will ensure comprehensive practices are implemented across Moderna’s global quality compliance program that will ensure global oversight and coordination of the inspection management process, support site inspections and adjudicate global commitments.   In collaboration with the key stakeholders, the team will implement and a establish a life cycle of continuous improvement.  The individual will also implement and maintain corporate inspection management tools. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems. This position will be located in Norwood, MA.

Here’s What You’ll Do:

  • Drive global oversight and coordination of the inspection management process

  • Develop and maintain updates to annual global inspection plan

  • Own relevant global inspection management process documents and ensure alignment with the Quality Management System (QMS) planning

  • Work directly with auditees to ensure completion of correct CAPA to address compliance concerns identified during inspections

  • Identify compliance risks and escalate issues to appropriate levels of management for resolution

  • Develop and report trends based on internal / external regulatory observations

  • Participate in the development, implementation and maintenance of procedures and templates to assist inspection responses and associated CAPA planning

  • Create, publish, and maintain metrics that measure the health and effectiveness of the inspection management program

  • Cascade defined inspection process strategy for appropriate execution to site and functional Subject Matter Experts (SMEs) and corresponding leadership for deployment of quality compliance program initiatives

  • Own and communicate metrics that provide visibility to quality compliance performance throughout the operation. Oversee overall performance and delivery of quality commitments in alignment with Quality strategies and with focus on continuous improvement

  • Maintain a strong network to promote a patient centered quality culture, drive and seek alignment of standard methodologies for leading regulatory inspections

  • Incorporate sound risk management principles for the establishment of global commitments

Here’s What You’ll Bring to the Table:

  • Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience.  BS with 8-10 years of experience or MS with 5-8 years experience in a pharmaceutical or biotechnology company.

  • Excellent organizational leadership competencies, inclusive of scheduling and leading team meetings that are effective, efficient, and documented

  • Ability to effectively communicate and influence the outcomes of decision-making process

  • Excellent skillset for influencing, being resourceful, managing conflict and negotiating.

  • Ability to work collaboratively with cross functional stakeholders to drive process improvements based on Quality Indicators

  • Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions

  • Ability to broker a strategic position after taking feedback from multiple sources

  • Experience driving decision making

  • Ability to succinctly communicate level of risk, priority, or impact to the business

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 winter shut down 
    •    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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

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 www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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