Head Quality Assurance de - Munich, Deutschland - Sandoz

Sandoz
Sandoz
Geprüftes Unternehmen
Munich, Deutschland

vor 3 Wochen

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung

2023 will see Sandoz become a standalone organization As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength Those joining Sandoz in the coming months will help shape the future of the company, it ́s growth, innovation, culture and how Sandoz impacts the lives of millions.

These will be careers with genuine impact This is one such role

  • Are you ready to make a difference?
    Your key responsibilities:

Your responsibilities include, but not limited to:

  • Lead the German Quality Team
  • Establish a stateoftheart Quality Management System that supports the overall business strategy and that is in line with the Global Sandoz Quality Management System and with all applicable regulatory requirements in Germany
  • Ensure that all internal and external service provider/supplier or partners (e.g., Co-Marketing, Co-Distribution) are adequately qualified and that roles and responsibilities are defined in Quality Agreements
  • Ensure that relevant Quality Documents under your responsibility are available in a timely and compliant manner (Quality Plan, Quality Risk Assessment etc.)
  • Establish regular review and assessment of Key Quality Indicators and ensure compliance with internal and external expectations
  • Ensure regular updates of the Sandoz Management Team on the overall GxPcompliance status (Annual Quality Management Reviews)
  • Act as the company key point of contact for Health Authority with regards to product defect reporting, FMDalert management and drug shortage reporting and proactively build a relationship with Health Authorities
  • Deliver successful GxP regulatory inspections and internal audits of the Sandoz Country Organization
  • Ensure robust performance management to optimize productivity across the organization. Provide active mentoring and coaching of associates at all levels. Drive efficiency gains through innovation and operational excellence projects
  • Attract and develop talent in the organization supporting a diverse and inclusive culture.

Commitment to Diversity & Inclusion:


  • Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Minimum requirements

What you'll bring to the role:

  • Master Degree or equivalent 4-Year University degree in a Scientific or Technology field Advanced degree preferred
  • 10 years of experience in Pharmaceutical Industry across Quality Commercial/Quality Operations/Manufacturing/Development.
  • Expert understanding of GxP regulations from major Health Authorities
  • Prior experience in the development and implementation of Quality Management Systems incl. Compliance & Auditing and dealing with Health Authorities
  • Demonstrated ability to build trusting relationships with senior management and other business stakeholders. Demonstrated business acumen and ability to identify stakeholders needs and adapt communications style
  • Fluency in German and English (oral and written), additional language(s) a plus

Desirable Requirements:


  • Demonstrated ability to initiate and drive organizational change in complex matrix environment. Ability to lead others through change, effectively manage resistance, and ensure organizational engagement. Ability to influence and drive/facilitate change across the organization.
  • Excellent communication, negotiation, consulting/facilitation, and interpersonal skills

Why Sandoz?

500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we're proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.


  • How will we do this? We believe new insights, perspectives and groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
  • We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying
    Imagine what you could do here at Sandoz

Commitment to Diversity & Inclusion:


Sandoz is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.


  • Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
    Division
  • SANDOZ

Business Unit

  • COMMERCIAL OPS EUROPE SZ

Country

  • Germany

Work Location

  • Holzkirchen (near Munich)

Company/Legal Entity

  • Hexal AG

Functional Area

  • Quality

Job Type

  • Full Time

Employment Type

  • Regular

Shift Work

  • No
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