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Vice President, Country Quality

vor 3 Monaten

Basel, Basel-Stadt, Schweiz Badrutt's Palace Hotel Vollzeit
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.

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 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

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

Here's What You'll Bring to the Table:
PharmD or Master's degree in Biology preferred; Bachelor's 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 indus
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