Vice President, Country Quality

The Role

Reporting to the SVP, Global Quality, the Vice President of Country Quality, based in Cambridge, MA, or Basel, Switzerland, will lead a team of quality professionals to support Modernas network of commercial affiliates. This critical leadership role will be responsible for ensuring the operations at the local country level follow global standards and will be accountable for monitoring the local country operations, ensuring compliance with local regulatory requirements for product release and distribution, advertising, pharmacovigilance, and market actions. This is an opportunity for someone to be a creator, a builder of teams and organizations, and contribute to Modernas business growth through building leading-edge capability in innovative, digitally enabled, end-to-end global quality and compliance in support of release and distribution of products to local markets around the world.

Heres What Youll Do:

• Provide highly strategic, inspirational leadership, leveraging extensive experience of leading and driving high-performing quality professionals to support the global commercial, supply chain, operations, regulatory, technical and safety organizations around the world.

• Deploy and lead strategic business reviews aligned with global supply chain, operations, and regulatory focusing on KPIs and the quality and compliance needs of the commercial organization to formalize decision processes and drive execution in global markets.

• Deploy a global risk management program consistently across the different countries, assess risks and define mitigation plans to offset them

• Oversee the thorough standardization and implementation of the company's quality system at local Moderna affiliates worldwide

• Partner with local, regional, and global operations, regulatory, commercial, and supply chain teams to foster a unified approach to compliance

• Serve as Modernas Management Representative and provide Quality expertise and leadership to team members at local Moderna affiliates worldwide

• Support local inspections and other Health authorities requests to obtain and maintain operating licenses

• Monitor industry and regulatory trends and ensure all new requirement is integrated in local operations to avoid risks of observations

• Ensure a well-balanced process for notification, reporting and other communications to Health Authorities

• Ensure the thorough and diligent handling of quality complaints and deviations, internal and external audits, inspections, certifications, and the definition of and monitoring of supportive CAPAs taken at local level

• Interact with the medical and pharmacovigilance team to ensure cases and queries are addressed satisfactorily in the various countries

• Collaborate with global and local business partners to support the Market access strategy and deliver timely on new product introduction

• Collaborate with the Supply chain and QA release team for the implementation and monitoring of the distribution system (contracts, specifications, etc.) and ensure compliance of GDP in all relevant countries

Heres What Youll Bring to the Table:

• PharmD or Masters degree in Biology preferred; Bachelors degree required

• 20+ years of experience in progressive multi-functional leadership roles within the pharmaceutical industry (quality, regulatory and pharmacovigilance area)

• Strong experience in GxPs and QMS

• Strong experience in global country regulations and guidelines (e.g., FDA, EMA, MHRA, PMDA, TGA) pertaining to GxPs

• Proven track record in creating and innovating digital solutions for core business process improvement

• Significant Change management experience including launch support

• Experience coordinating and managing Health Authority inspections

• Outstanding communication skills (verbal and written) and fluent in business English

• Reputation for superior customer service with excellent interpersonal skills

• Ability to work in a highly collaborative way that maintains a flat organization and supports fast paced environment and decision-making

• Ability to interact effectively with all levels of personnel within the organization.

• Proven track record of coaching and developing team members. You will be bold in suggesting new and innovative process and systems improvements

• You will be relentless in your pursuit of ambitious goals and excellence

• You will be curious to seek our new ways of doing things and disrupt the traditional large pharma mindset

Critical competencies for success

Demonstration of the following performance and personal competencies will define success in this role:

Setting Strategy

• The ability to create and articulate an inspiring vision for the organization, for the areas over which you are directly responsible and for the enterprise as a whole.

• The inclination to seek and analyze data to support decisions and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.

• The ability to effectively balance the desire/need for broad change with an understanding of how much change the organization is capable of handling, to create realistic goals and implementation plans that are achievable and successful.

Executing for Results

• The ability to adapt nimbly and lead others through complex situations, exhibiting comfort with ambiguity and uncertainty.

• The drive to seek data and input from others to foresee possible threats or unintended circumstances from decisions and use that data for risk assessment, ensuring that we take smart risks.

• A leader who acts in a transparent and consistent manner while always considering what is best for the organization and who is acknowledged by others as having a high degree of integrity and forethought in your approach to making decisions.

Leading Teams

• The ability to attract and recruit top talent, motivate the team, delegate effectively, celebrate diversity within the team, and manage performance; widely viewed as a strong developer of others.

• The ability to persevere in the face of challenges and exhibit a steadfast resolve and relentless commitment to higher standards, which commands respect from followers.

• Self-reflection and awareness of your own limitations; leading by example and driving the organization's performance with an attitude of continuous improvement and openness to feedback and self-improvement.

Relationships and Influence

• Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.

• Exhibits ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in his/her beliefs, and active drive.

• Encourages others to share the spotlight and visibly celebrates and supports the success of the team.

• Creates a sense of purpose/meaning for the team that generates followership beyond your own personality and engages others to the greater purpose for the organization as a whole.

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!

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 persons 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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