For our location in Bern (Switzerland), Marburg (Germany), King of Prussia (USA) or Broadmeadows (Australia), we are looking for aGRA Process Excellence & Compliance Senior Manager (100%) (m/f/d)Main Responsibilities and Accountabilities:
The Global Regulatory Affairs (GRA) Process Excellence & Compliance Senior Manager is responsible for the oversight of Process Management and Compliance within Global Regulatory Affairs (GRA). They are also responsible for executing and overseeing the QMS strategy and system of the GRA dept. This role will participate in GRA and cross-functional global projects, audits and inspections related to QMS and training management systems.
In close collaboration with the Process Excellence & Compliance Lead, this role is coordinating, overseeing and managing self-inspections in GRA and is acting as a key contact for internal audits of GRA including coordination of CAPA processes. The role is also supporting regulatory agency inspections and related follow up activities in GRA. The Business Process Excellence & Compliance Senior Manager oversees the GRA training strategy and systems.
The role will be responsible for defining and implementation of global and/or regional compliance strategies for new and existing regulatory processes, enabling the organization to conduct its current and future business activities. As such the incumbent is responsible for participating in process improvement activities in support of GRA & in line with industry best practices.
The Process Excellence & Compliance Senior Manager establishes and maintains effective relationships with cross-functional stakeholders to further enhance process excellence and compliance strategies and practices.
The Senior Manager will be expected to anticipate and analyze changes to the enterprise and departmental needs, and partners with other organization functions to generate strategic impact analysis of such changes. It is expected that this position will provide the necessary tools, to inform decision-making and provide the organization with a competitive advantage.Qualifications & Experience:
- Bachelor degree in a Life Science (Science, Pharmacy, Engineering) or Advanced degree in a Life Science (PhD, MD) with Business (MBA) an advantage. Other degrees and certifications considered if commensurate with related quality management, regulatory or clinical research experience.
- 5-7+ years regulatory experience in the pharmaceutical industry.
- Compliance and Regulatory experience is a must.
- Demonstrated subject matter expert in regulatory or quality compliance obtained through advanced education and/or extensive work experience.
- Experience in implementation and/or oversight of Quality Management Systems, including management of procedural document, training requirements and inspections or audits.
- Working knowledge of GMP, GCP and GLP, ICH guidelines and related regulatory guidelines.
- Knowledge of process management, process performance, continuous improvement and project management an advantage.
- Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment.
- Commitment to Quality and Compliance. Business acumen & industry knowledge.
- Proven ability to deliver successful outcomes to internal and external customers while meeting business objectives.
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.
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CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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