Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Senior Change Management Expert PV IT Compliance

Your tasks and responsibilities

The primary responsibilities of this role, Senior Change Management Expert PV IT Compliance, are to: 

  • Responsible for defining short-term and mid-term strategy for validation for all GxP-relevant PV IT systems;
  • Organize, negotiate, coordinate and communicate resource, schedule and budget requirements for validation activities for:
  • Relevant system releases;
  • System bug fixes and patches;
  • User initiated system configuration changes Change Management;
  • Lead the Technical Team which includes members from PV System Management and Analytics, BS IT BP and BS ITO;
  • Lead external validation resources
  • Plan change implementation in coordination with BS, PV Case
  • Lead large validation projects
  • Responsible for validation strategy for PV IT systems by
  • Identifying the right tasks, re-designing validation processes and identifying external partners for validation;
  • Ensuring IT compliance during transition of strictly in-house hosted systems to cloud-based systems;
  • Ensuring IT compliance for new innovative technologies such as automated systems (e.g. robots, AI) requiring to establish new validation strategies;
  • Plan activities for system validation, including prioritization, scheduling and resource allocation;
  • Ensure creation, review, execution, signoff and archiving of appropriate GxP-compliant documentation;
  • Inspection Readiness: Ensure adequate documentation for PV system-related CAPAs arising from inspections, external audits, internal audits and business reviews;
  • Document performance or compliance relevant system changes as CAPAs;
  • Participate in conduct of PV related audits and inspections
  • Represent PV System Management and Analytics processes and standards in audits and inspections, including demonstrating validation approach and documentation for global systems used in PV;
  • Contribute information for the maintenance of the PV System;
  • Master File (the key regulatory document describing the overall Bayer Pharmacovigilance System);

 

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:

 

Required Qualifications:

 

  • MD degree with 2 years of pharmacovigilance experience and 2 years of clinical experience; OR a PhD, PharmD, DPM, or DVM degree with 5 years pharmacovigilance and 2 years of clinical experience; OR a Masters or Bachelors degree (preferred: MBA, MS, BS RPH, RN HCP, or Life Science degree) with 8 years of pharmacovigilance experience and 2 years of clinical experience;
  • 10 years of experience in large GxP/CSV & IT projects including leading the validation work stream of such projects;
  • Proficient understanding of regulatory roles and regulations, such as FDA rules and ICH principles;
  • Diversified knowledge also includes internal safety policies and procedures, also as a contributor to such documents;
  • In-depth understanding of IT processes, IT project management skills as well as broad knowledge of the R&D-related IT system landscape and processes;
  • Flexibility and responsiveness to quickly realign resources when necessary in order to meet critical project timelines;
  • Must possess managerial skills including exceptional abilities for organization, supervision, and follow-through;
  • Superior oral and written communication skills in English language;
  • High social competency with excellent communication and presentation skills across all hierarchy levels;
  • Quality traits of diplomacy, professionalism, tact, and arbitration are of paramount importance to this position.

 

Preferred Qualifications:

  • Experience as a CSV auditor;
  • Additional languages are beneficial.

 

 

Domestic Relocation assistance offered on this role.

 

#LI-US

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

 

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

 

Country: United States
Location: NJ-Morristown
Functional Area: [sap_fa_30]
Entry Level: 5