Head of Commercial Quality

Vor 5 Tagen

Baar, Schweiz Biogen Vollzeit

Job Description

About the role

Location: Baar, Switzerland as per our hybrid HR policy

You provide/ensure quality assurance oversight of distributed products in markets where Biogen products are commercialized. Define Affiliate Quality Management systems required to meet cGDP and other applicable regulations and ensure compliance of local QMS with Biogen’s global quality system requirements, relevant regulatory requirements, and applicable licenses. In this leadership role, you oversee and define Quality requirements to Partner Markets and assure QA market-specific requirements from Biogen are communicated to required stakeholders. Ensure Quality oversight for product shipping and storage conditions, including compliance against the submitted dossier with local health authorities. You also ensure all Quality distribution requirements are implemented to support market expansion launch activities. Collaborate with all necessary stakeholder functions and ensure Quality is represented in cross-functional decisions. You lead a global team and influence Quality collaboration and decision-making with non-direct reporting QA colleagues.

You will report to the Head of External and International Quality.

What you'll do

  1. Provide quality assurance strategy, decision making and support in Affiliate and Partner Markets:
    1. Ensure Affiliate License compliance for distribution activities through identification and monitoring of regulations, reviewing licensing requirements and supporting license changes and applications when needed.
    2. Establish GxP system and procedures to support new affiliate operations and licenses. Define systems as required to support GxP activities at the affiliates (e.g. documentation management, training, audit, deviation, CAPAs, change control, Management Review, risk management, Quality Agreements, customer qualification, product release, falsified medicines).
    3. Ensure appropriateness and alignment of Global Quality Management Systems with affiliate requirements.
    4. Drive inspection readiness and coordination of health authority inspections at Affiliate and Partner Markets.
    5. Establish and monitor appropriate KPI tracking and reporting.
    6. Collaborate with required functions to support audits and facilitate remediation of audit findings.
    7. Ensure Quality oversight of in-country method transfer activities; oversee in-country testing and coordinate supply of standards to enable product testing and release.
    8. Foster Quality culture at all Affiliates.
  2. Oversee Biogen International Distribution for Commercial and Expanded Access Programs
    1. Oversee logistics related QMS and worldwide distribution including central warehouse management and shipping.
    2. Coordinate qualification of logistics partners and customers with Affiliates/Distribution Partners and External Audit Teams.
    3. Develop and maintain quality agreements with logistics partners, wholesalers, warehousing and distribution partners.
    4. Support supply chain efforts to maintain OTIF; distribution model changes and serialization efforts.
    5. Provide quality assurance oversight for Managed Access Programs.
  3. Manage Product Related issues in market
    1. Support Recall Process and activities as defined by the recall committee.
    2. Monitor market activities and escalate issues appropriately.
    3. Minimize and manage out of stock situations.
    4. Coordinate and manage communications with regulatory authorities related to product shortage.
  4. Manage direct reports and managers of managers to increase their performance and effectiveness:
    1. Provide operational guidance and support to reports.
    2. Support employee development.

Qualifications

  • BS degree in related field (PharmD, PhD or advanced degree strongly preferred).
  • Minimum of 15 years of experience in leadership roles preferable in the pharmaceutical industry.
  • Previous experience in GDP and distribution of pharmaceutical products.
  • Quality and Compliance experience consistent with world-wide regulatory requirements, including working knowledge in ISO requirements/Certification Process.
  • Expert knowledge of US and International cGxPs, ISO, ICH and Device regulation.
  • Thorough understanding of regulations on Good Manufacturing Practices and Good Distribution Practices.
  • Ability to hire and retain top talent.
  • Track record of developing and leading leaders.
  • Ability to influence the organization.
  • Flexible when priorities change.
  • Strong leadership abilities required to effectively implement change management strategies.
  • Demonstrated ability to successfully manage conflicts and solve problems.
  • Excellent oral and written communication skills. Thorough knowledge of FDA, EU and ROW regulations as they relate to GDP and GMP requirements.
  • Proficiency in English, other languages are an asset.

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

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