Vp, Country Quality Jobs

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 Moderna’s 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 Moderna’s 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.

Here’s What You’ll 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.
• Interact with the medical and pharmacovigilance team to ensure cases and queries are addressed satisfactorily in the various countries
• Serve as Moderna’s 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
• 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.
• Ensure a well-balanced process for notification, reporting and other communications to Health Authorities
• 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
• Deploy a global risk management program consistently across the different countries, assess risks and define mitigation plans to offset them
• 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
• Monitor industry and regulatory trends and ensure all new requirement is integrated in local operations to avoid risks of observations
• 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

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

• Reputation for superior customer service with excellent interpersonal skills
• Strong experience in GxPs and QMS
• PharmD or Master’s degree in Biology preferred; Bachelor’s degree required
• Significant Change management experience including launch support
• Ability to work in a highly collaborative way that maintains a flat organization and supports fast paced environment and decision-making
• Proven track record in creating and innovating digital solutions for core business process improvement
• Outstanding communication skills (verbal and written) and fluent in business English
• Experience coordinating and managing Health Authority inspections
• You will be curious to seek our new ways of doing things and disrupt the traditional large pharma mindset
• You will be relentless in your pursuit of ambitious goals and excellence
• Strong experience in global country regulations and guidelines (e.g., FDA, EMA, MHRA, PMDA, TGA) pertaining to GxPs
• 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
• 20+ years of experience in progressive multi-functional leadership roles within the pharmaceutical industry (quality, regulatory and pharmacovigilance area)

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 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.
• 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.

Executing for Results

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

Leading Teams

• 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.
• 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.

Relationships and Influence

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

• Vacation, sick time and holidays
• 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
• Adoption and family-planning benefits
• Paid sabbatical after 5 years; every 3 years thereafter
• Location-specific perks and extras!
• Exclusive preferred pricing on Peloton fitness equipment
• Discretionary year-end shutdown
• Generous paid time off, including:
• Volunteer time to participate within your community
• Dedicated care coordination support for our LGBTQ+ community
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• 401k match and Financial Planning tools
• Highly competitive and inclusive medical, dental and vision coverage options
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Free premium access to fitness, nutrition, and mindfulness classes
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free parking or subsidized commuter passes

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure 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 people are 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. 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 [email protected]. (EEO/AAP Employer)

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