Healthcare Compliance Manager (m/f)

Commercial Operations

Our Mandator is a leading operating biopharmaceutical enterprise with a presence in more than 70 countries.

 

We are searching as soon as possible for a dedicated and experienced

Healthcare Compliance Manager (m/f)

Commercial Operations

  • Bereich:

    Medical

  • Berufssparte:

    Zulassung/Regulatory Affairs

  • Arbeitsregion:

    Großraum München

  • Art der Anstellung:

    permanent

  • Kennziffer:

    24334

  • Aktualisierung:

    2017-11-21

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Your Responsibilities

  • Support to plan, design, operationalize, implement and monitor the local cross‐functional Healthcare Compliance program to ensure local compliance with applicable internal and external rules and regulations
  • Support and advise HCC Board in all HCC relevant questions
  • Report on a regular basis to the local HCC board on compliance matters assisting the General Manager and the HCC Board to establish appropriate methods to reduce the companies' healthcare compliance risk
  • Provide advice, guidance, and support to the affiliate staff on the interpretation and implementation of the local trade association code, the companies' Corporate Policies and other applicable rules and regulations assisting in creating a culture of compliance. This includes promote an open communication and dialogues where affiliate staff feel comfortable speaking up
  • Manages day‐to‐day operation of an effective HCC system for the organization
  • Institutes and maintains an effective compliance communication for the organization, including promoting use of the Compliance Hotline
  • Support with the periodically review and update of the local HCC program, as appropriate, to respond to changes in the companies' needs and applicable local and global requirements, identified weakness in the program or identified systemic patterns of noncompliance
  • Develop, coordinate, and participate in multifaceted educational and training program that focuses on the elements of the compliance program, and seeking to ensure that all affected employees and management are aware of, understand and comply with pertinent standards
  • To work with the HCC Lead to review and act in response to reports of noncompliance, lead, coordinate and conduct internal investigations as well as ongoing risk assessment, evaluation, anticipation, minimization and avoidance. This includes establishing and implementing remedial activities for specific local HCC audit findings or other potential risk areas and interacting and following through with applicable departments and functional heads for corrective actions, preventive actions and implementation
  • Remain informed of developments in applicable HCC and general compliance rules, laws and enforcement trends 
  • Works with the Human Resources Department and others as appropriate to develop an effective compliance training program, including appropriate introductory training for new employees as well as ongoing training for all employees and managers
  • Maintain awareness of current legislation and corporate policies to ensure these are reflected in local procedures
  • Act as contact for global compliance for activities in the scope of HCC: local self‐inspections and review, translation of Corporate Policies, Regional Template SOPS, presentations, communications and trainings
  • Coordinates HCC Due Diligence of vendor organizations
  • Acts as local designated compliance responsible
  • Reviews and approves local preparation of standard contracts
  • Represents local HCC on global, international or regional cross functions teams
  • Participates in HCC audit preparations: prepare documentation requests, set‐up meetings with applicable functions and team members
  • Leads and supports HCC action plans, preventive and corrective actions as per HCC audit results

Your Qualification

  • The candidate must have extensive HCC experience. Additional certifications will be considered plusses
  • Minimum of 4 years experience in HCC in the life sciences industry / Pharma industry
  • Life sciences/pharma audit background will be considered plusses
  • Experience with local HCC regulations and industry codes would be also considered a plus
  • Project management skills
  • Demonstrate character, with high level of integrity and honesty
  • Achieve results, driving execution, speed and efficiency
  • Inspire and motivate, promoting open communication and foster teamwork
  • Ability to work in a geographically dispersed and multi‐cultural team
  • Lead change, driving innovation and applying global mindset
  • Demonstrated ability to build alignment, influence, execute and connect cross‐functional and at all levels of the organization
  • Strong interpersonal and organizational skills with high emotional intelligence and be an excellent listener
  • Effective communication at all times and experience in delivering complex messages, to a diverse audience with a track record of effective and influential presentations
  • Strong identification with companies' values
  • Proven team player with ability to navigate cross functionally
  • Ability to build strong credibility at local level, to effectively interact, providing direction, challenge and support whenever relevant
  • Fluency in English is required
  • Act as a role model for ethical behavior

Your contact person

Tilman Grumbd
Geschäftsführer

Anschrift

Optares Medical GmbH & Co. KG
Tilman Grumbd
Heiligengeist Höfe 8
26121 Oldenburg