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(Senior) Manager Health Care Compliance and Quality Assurance (RP)

Req #: 1701049
Location: Utrecht, NL
Job Category: Regulatory Affairs
Work Location: Winthontlaan 6 UTRECHT 3526 KV
Organization: Celgene BV
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:Netherlands- Utrecht

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary

The (senior) manager health care compliance (HCC) and quality assurance (QA) is responsible for the health care compliance role in the Netherlands. The manager will act as compliance officer, and defend and maintain HCC standards according to current legislation in the Netherlands and global policies/procedures. In addition, he/she will be responsible for the quality assurance function within the Netherlands affiliate. 

The (senior) manager will provide guidance to multidisciplinary teams (e.g. disease teams) to ensure that all HCC activities developed and performed are in compliance with applicable regulatory demands (legislations and guidelines). In addition, the (senior) manager is responsible for managing the quality management system to ensure quality of all Celgene B.V. procedures and compliance with local regulations. The (senior) manager will function as one of the Responsible Persons (RP) for GDP within the affiliate.

Health Care Compliance:

  • Plan, design, operationalise and maintain the local healthcare compliance HCC program (set of SOPs, trainings, communications, controls, reports) to ensure compliance with the applicable HCC requirements
  • Review local HCC activities in accordance with corporate global policies, local SOPs and local code
  • Participate in HCC audit preparation: prepare documentation requests, set-up meetings with the applicable functions/team members
  • Lead/support HCC action plans, preventive actions corrective actions (CAPAs) as per HCC audit results
  • Support the senior management. & general manager to identify the need for specific local processes, procedures and tools to accomplish HCC initiatives and goals and act in accordance to mitigate the relevant risks
  • Evaluate the need and develop/revise healthcare compliance controlled documents, templates and training, if necessary.
  • Act as key contact point for healthcare compliance within the affiliate with the HCC EMEA director, the general manager and the global compliance group (GCG) for activities in the scope of HCC
  • Review, translate, (if applicable), provide comments and implement HCC SOPs, presentations, communications and trainings.
  • Represent local HCC on global, international or regional cross-functions teams (including EMEA HCC Forum).
  • Provide advice, guidance, and support to the affiliates staff on the interpretation and implementation of the local trade association code, Celgene corporate global policies and other applicable rules and regulations
  • Assist in the implementation of the corporate compliance program
  • Provide an overview of the local compliance status to the general manager, EMEA HCC director and to the global compliance group (as appropriate).
  • Participates in the approval process of all oral and written promotional or non-promotional items for external audiences according to the regulations and legislations in the Netherlands.
  • Represents Celgene’s interest in national and international HCC forums and influence groups.
  • Monitors national and international applicable legislation.

Quality Assurance

  • Develops, initiates, maintains, and revises policies and procedures for the general operation of the compliance program (including but not limited to complaint handing, product recall, external audit and self inspection program, product returns) and its related activities to prevent illegal, unethical, or improper conduct. Manages day-to-day operation of the program.
  • Develops and periodically reviews and updates the quality handbook to ensure continuing accuracy and relevance in providing guidance to management and employees.
  • Manages a local quality management system.
  • Works with senior management, and others as appropriate to develop and implement an effective compliance training program, including appropriate introductory training for new employees as well as ongoing training for all employees and managers.
  • Identifies potential areas of compliance vulnerability and risk; develops/ implements corrective and preventive action (CAPA) plans for resolution of problematic issues, and provides general guidance on how to avoid or deal with similar situations in the future.
  • Coordinates local audits and subsequent CAPA actions.
  • Monitors national and international compliance legislation and institutes and maintains an effective compliance communication program for the organisation, including promoting heightened awareness of standards of conduct, and understanding of new and existing compliance issues and related policies and procedures. Informs the medical director and senior management on a regular basis including proposals for any actions in case of compliance issue/concern.
  • Performs and has the authority to perform the duties of a Responsible Person for GDP as defined in guidance document 2013/C 343/01 and the Dutch medicines law in accordance with the applicable local laws and regulations of the Netherlands, and be registered as such on the pharmaceutical license.
  • Assists with respect to quality control in connection with Celgene's pharmaceutical activities, specifically regarding recall operations, complaints and returns management, customer approval.
  • Communicates on behalf of Celgene with the Dutch health care authorities regarding issues relating to Celgene pharmaceutical activities and products.
  • Stimulates a culture of constant improvement of quality standards in the organisation.
  • Acts as deputy to the director regulatory affairs, health care compliance & quality assurance.

Skills/Knowledge Required:

  • University degree in a relevant scientific discipline (pharmacist is preferable).
  • Minimum of 5-10 years pharmaceutical industry experience in the relevant areas of health care compliance and quality assurance.
  • Specific expert knowledge in the area of HCC and quality assurance.
  • Must understand the principles of quality management and will be conversant with e.g. ICH quality guidelines Q9 and Q10, and EU guidelines 2013/C 343/01 on good distribution practice.
  • Specific training as required by the inspectorate to be accepted as RP-GDP.
  • Excellent communication skills (verbal and written) in Dutch and English.

Core Competencies

  • Ability to build national networks and relationships.
  • Anticipate trends/changes in regulatory environment.
  • Advanced understanding of structure & workings of regulatory bodies in country assigned.
  • Must be able to innovate, analyse and solve problems with minimal supervision and attention to detail.
  • Inter-dependent partnering skills, team-oriented and ability to influence outcomes.
  • Negotiation, collaboration, persuasion, communication and relationship building skills.
  • Discrete and able to protect confidential information.
  • Investigative and problem-solving skills.
  • Role model for ethical behavior exhibiting the highest levels of integrity

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