Senior Manager Development QA Ra Operations - Kundl, Österreich - Sandoz

Sandoz
Sandoz
Geprüftes Unternehmen
Kundl, Österreich

vor 1 Woche

Anna Müller

Geschrieben von:

Anna Müller

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?

Job Summary/Purpose:


  • Gives QA support and oversight for Sandoz Global Development
  • Regulatory Affairs (RA) operational activities to ensure compliance of RA organization to Sandoz QMS requirements by being the single point of contact for RA.
    Your Key Responsibilities

Your responsibilities include, but not limited to:

  • Act as QA approver for Regulatory Affairs topics within QA systems; therefore such as but not limited in exception management record, change control, GxP procedures, closely collaborate with various stakeholders
  • Support and/or participate in Selfinspections (SI) within RA, HA/preapproval inspections and global audits, act as QA as necessary.
  • Give QA advice to RA processes and procedures (best practice sharing).
  • Support implementation and execution of the Quality Plan and Data Integrity Plan items in regard to Regulatory Affairs.
  • Support activities from incidents e.g. escalations when related to regulatory compliance or directly linked to RA related topics.
  • Collect and participate in the review of RA metric (KQIs). Monitor and review of trends and support RA functions to determine and implement actions. Participate in quality management reviews for RA
  • Support GxP relevant organizational changes in RA
  • Together with RA disclose risks related to regulatory and quality compliance, ensure risk communication/ escalation and mitigation.

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:

  • Degree in Biology, Biochemistry, Chemistry, Pharmacy or related science
  • Minimum 5+ years of experience within the pharmaceutical industry e.g. in Pharmaceutical Development and / or Quality Assurance
  • Regulatory affairs experience advantageous
  • Profound knowledge of GMPs and regulatory guidelines regarding scope
  • Extensive on the job QA experience ability to work operationally and strategically
  • Knowledgeable and experienced in delivering in a matrix organizational environment, good stakeholder management skills
  • Curious, agile and performance driven mindset
  • Collaborative cross functional team player with business results mindset
  • Experienced in working in an intercultural environment
  • Quality mindset, always looking for improvement and best practice sharing
  • Motivated by challenge and change
  • English business fluent

Orbit
Austria only:
Minimum annual gross salary € 66526,88 (on a full-time basis)
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 achieve here at Sandoz

Division

  • SANDOZ

Business Unit

  • COO SZ

Country

  • Austria

Work Location

  • Kundl

Company/Legal Entity

  • Sandoz GmbH

Functional Area

  • Quality

Job Type

  • Full Time

Employment Type

  • Regular

Shift Work

  • No

Early Talent

  • No
Mehr Jobs von Sandoz
Alle Jobs von Sandoz anzeigen