Labeling Change Management and Quality Lead (m/f)

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The purpose of this role is to lead the Artwork & Labelling Global Quality team for Shire. This team is responsible for oversight of the artwork management/labelling change process to ensure clear requirements are defined and executed to enable release of artwork to CMO/print vendor.


This role leads and/or supports global project teams, ensures effective deployment of internal/external quality and regulatory requirements, and drives harmonization and continuous improvement efforts globally in alignment with Shire?s Quality Management System, specifically in the areas of responsibility and Subject Matter Expertise.

About the position:

  • Oversight of the artwork management/labeling change process to ensure clear requirements are defined and executed to enable release of artwork to CMO/print vendor
  • Leads the Artwork and Labeling Global Quality team for Shire
  • Presides as the Subject Matter Expert for Quality Systems in the areas of responsibility/expertise
  • Responsible for fostering an environment that embraces employee development and holds teams responsible for managing performance, developing a strong talent bench, and succession plan for key roles
  • Manages contractors, direct reports and/or other quality personnel as required
  • Budget development, monitoring and adherence for Artwork & Labeling Quality Team
  • Supports integration of new acquisitions into the Shire Quality System in the areas of responsibility and expertise
  • Acts as a mentor to others within the organization to further develop others and grow the organization
  • Participate in auditing of artwork outsources as requested
  • Participates and/or interfaces with inspectors during regulatory inspections
  • Develops, gathers, and evaluates relevant metrics 
  • Develops, owns and performs training for global procedures related to his/her areas of expertise
  • Obtains resolution on areas identified as non-conformance related to his/her areas of expertise
  • Drives innovation within areas of responsibility through identifying and implementing continuous improvement opportunities with the objective of achieving operational excellence

Skills you need:

  • Bachelor?s degree or equivalent in engineering or applied science
  • Advanced degree in complimentary field of study 
  • >10 years in pharmaceutical manufacturing/quality operations 
  • Packaging and labeling experience 
  • Experience leading teams in multiple regions
  • Auditing experience
  • People manager and leader capable of developing people and teams with > 5 years of management experience (preferred)
  • Oversight of CMO Operations (preferred)
  • Recognized as a leader and key collaborator with the ability to work in a matrix environment
  • Knowledge of FDA regulations and GxPs
  • Ability to make difficult, but robust, rationalized and timely decisions balancing the totality of available data and risk 
  • Must be self-driven and have the ability to operate with limited direction and be able to give direction to contractors, direct reports, and/or other personnel
  • Ability to create a vision and motivate others to achieve that vision
  • Ability to create an enabling culture and corresponding high performing team
  • Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team leader or team member, share information with a team, and to champion change
  • Demonstrate strategic thinking, business acumen and process assessment capability
  • Must have the ability to handle highly complex problems and have excellent analytical and investigational skills 
  • Strong process and project management skills
  • Excellent English skills, German is a plus
  • Domestic and international travel will be required to facilitate robust partnerships and execution. Depending on growth of organization and the primary work location, travel is estimated to be 20%.

As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees - our biggest asset - who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.

We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!

The minimum salary according to collective agreement for this position is € 4.094,41 gross per month (full-time); increased payment is intended; in addition we offer an attractive monetary incentive program.  We are looking forward to your application.



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