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Manager Data Integrity

Location: 

Bern, CH

Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life. As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats. We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

At Emergent BioSolutions Berna, the Swiss affiliate there are approx. 140 dedicated and committed professionals working in the departments Manufacturing, Quality Assurance, Quality Control, Supply Chain and Regulatory Affairs.

We want to strengthen our Quality team with a   

Manager Data Integrity

Main responsibilities:

  • Responsible for the overall planning, management and execution of all DI gap assessment and remediation activities at the site utilizing global Data Integrity tools and methodologies.
  • Ensuring all computer systems used in the manufacture, testing, and storage of GMP materials have been validated and controlled to meet current regulatory requirements and guidance.
  • Ensuring ALCOA elements and controls are embedded in site policies, procedures, and mater record templates
  • Facilitate role appropriate training of all employees at the site to ensure full understanding of their role with respect to Data Integrity/Data Integrity.
  • Establishing effective means of monitoring and communicating the ongoing health of the site Data Integrity/Data Integrity program
  • Create and manage metrics for site accomplishments and status, relative to requirements established in the global Data Integrity plan
  • Identify, assess and mitigate business change impact by owning the development and execution of user acceptance testing, training documentation, training scheduling and effective business communication
  • Monitor emerging digital technology capabilities and related global regulatory requirements and maintain site Data Integrity/Data Integrity program to current regulatory and industry standard.

 

Qualification requirements:

  • Bachelor’s Degree in biological, engineering or computer science, or equivalent experience in a Pharma/Biologics environment
  • Minimum of 8-10 years of pharmaceutical experience with specialized experience applying Data Integrity assurance, 21 CFR Part 11 and EU Annex 11, and computer systems validation requirements
  • Broad working knowledge of GxP and ISO regulations and guidance
  • Demonstrated experience in GxP best practices in a pharmaceutic/biologics environment, Data Integrity requirements, and computer systems compliance
  • Proven technical understanding of complex manufacturing systems & laboratory equipment and of related qualification requirements.
  • Effective and proven project management, including strong planning skills
  • Ability to critically evaluate data summaries and conclusions
  • Ability to effectively and inclusively uncover root cause of Data Integrity issues and subsequently define, implement, and apply interim and long-term control solutions
  • Knowledge and practical experience with quality metrics and trending
  • Proficient in all MS Office applications (Excel, PowerPoint, etc.)
  • Multilingual – at least German and English, written and spoken

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.