Digital Gxp Compliance Manager

Vor 7 Tagen

Basel, Schweiz Bayer Vollzeit

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Digital GxP Compliance Manager (M/F/d)**

**YOUR TASKS AND RESPONSIBILITIES**

The primary responsibilities of this role, Dir Digital GxP Compliance Management, are to:

- Translate digital and business strategies into GxP compliant design, implementation, operation of proactive mitigation measures to ensure GxP compliance of Bayer’s digital landscape.
- Drive and oversee planning for IT system, IT service and IT supplier audits in line with the business strategies and requirements of Bayer PH/CH R&D, PV, MA, Radiology.
- Lead cross-functional global audits of complex and critical IT systems, IT services and IT suppliers, including design of audit plans, communication of outcome to senior management, assessment of corrective and preventive actions to improve compliance and efficiency of processes.
- Support Health Authority inspections by providing functional expertise.
- Provide interpretation and guidance for stakeholders on quality related regulations / guidelines (e.g. FDA, ICH, EMA, etc.) as well as company procedures and policies, proactively maintaining cognizance of current and evolving GxP IT system and IT service standards.
- Ensure and maintain awareness of internal inspection readiness by developing effective training and communication concepts to enable business functions to identify business and compliance risks.
- Foster a positive spirit and create a positive sense of GxP compliance value to exploit the full potential of digital solutions.

**WHO YOU ARE**

Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

- Bachelor’s degree in a biomedical science, or master’s degree in business administration, information technology or risk management or equivalent education with long-term of pharmaceutical industry experience with broad knowledge in quality management, digitalization initiatives, IT system development and supplier management.
- Proven team leadership, motivational and interpersonal skills
- Several years proven record in IT auditing
- Certifications in CISM (Certified Information System Management) or CISA (Certified Information Systems Auditor) desired
- Detailed knowledge of international/regional/local Good Practices, Pharmacovigilance and IT System regulations and guidelines including internal Bayer IT guidelines
- Competency and knowledge in digitalization & new technologies impacting quality and compliance, efficient use of new IT tools and technologies in day-to-day operation, IT savviness and innovative mindset
- Understanding different cultures present within the global organization and IT suppliers
- Strong communication skills to ensure that audit activities and status are transparent, and that risks, issues, and results are clear to all involved parties, up to senior management
- Strong presentation skills including flexibility considering multi-cultural target groups
- Executes his/her responsibilities with knowledge, accuracy, persistence, resilience, and creativity seeking to work both independently and collaboratively
- Self-motivated and goal-oriented with a high degree of initiative and follow-up skills
- Strong analytical and problem-solving skills
- Strong collaboration skills and ability to work in both cross-functional and global teams
- Frequent global travel required

Domestic relocation may be offered for this role.

LI-GH

LI-UK

LI-CH

**YOUR APPLICATION**

**Location**:
Whippany, New Jersey, USA; Basel, Switzerland; or Reading, Berkshire, United Kingdom

**Division**:
Pharmaceuticals

**Reference Code**:
560025

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