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.
The Affiliate Healthcare Compliance and Quality Associate Manager is responsible to assist Celgene Slovakia and Czech Republic in the operationalization and implementation of Celgene corporate policies as well as oversight the local Healthcare Compliance Program. This position will require close collaboration and coordination with General Manager / Country Manager, local management team and local functions, regional and global HCC functions, Legal, Internal Audit. Specific responsibilities include but are not limited to the following:
• Plan, design, operationalize, monitor and oversee the local Healthcare Compliance (“HCC”) program to ensure local compliance with applicable internal and external rules and regulations (e.g., local Code, Corporate Policies, local specific legislation);
• Report on a regular basis to the local Management Team on compliance matters and assisting the General Manager/Country Manager and the Management Team’s members to establish appropriate methods to reduce the company’s healthcare compliance risks;
• Work in close cooperation with the General Manager / Country Manager to create a culture of compliance and set the tone at the top. This includes promote open communication and dialogues where staff members feel comfortable speaking up;
• Provide an overview of the local compliance status to global Compliance (as appropriate);
• Periodically review the local HCC program, as appropriate, to respond to changes in the company’s needs and applicable local and global requirements, identified weakness in the program, or identified systemic patterns of noncompliance;
• Develop, coordinate, and participating in a multifaceted educational and training program that focuses on the elements of the compliance program, and seeking to ensure that all affected employees and management understand and comply with pertinent standards;
• Review and, where appropriate, act in response to reports of noncompliance. This includes taking a leading role in 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;
• Act as key contact for local HCC Audit: provide advanced information, prepare documentation, identify local functions/team members;
• Act as key contact point for global compliance for activities in the scope of HCC. This includes local self-inspections and the review and translation (if applicable) of Corporate Policies, Regional Template SOPs, presentations, communications and trainings;
• Represent local HCC on global, international or regional cross-functions teams (including EMEA HCC Forum);
• Remain informed of developments in applicable HCC rules and enforcement trends.
• Ensures proper maintenance and implementation of Celgene SK&CZ Affiliates Quality Management System: Supervises correct drafting, issuing and storage of local controlled documents.
• Responsible for ensuring continuous and initial training programs are implemented and maintained.
• Manages Product Quality Complaints (PQCs), product returns and product recalls in accordance with Celgene’s applicable procedures and GDPs.
• Supports Celgene Logistics to oversee Contract Service Providers to ensure GDP compliance of storage, transport and distribution activities as per Technical and Quality Agreement.
• Responsible for preparing and hosting of internal Corporate audits and GxP Health Authority Inspections.
• Coordinate with the Global Compliance GxP Audit and Inspection Group.
• Science Degree and other similar qualification. Candidates will be considered only if they have extensive HCC experience. Additional certifications (e.g., HCC certification, etc.) will be considered plusses.
• Fluency in English is required
• Minimum of 3+ years experience in HCC and 10 years in the life sciences/pharma industry.
• Experiences in Quality management systems
• Life sciences/pharma audit background will be considered plusses
• Experience with local HCC regulations and industry codes
• 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
• Lead change, driving innovation and applying global mindset
• Demonstrated ability to build alignment, influence, execute all levels of the organization
• Superior interpersonal and organizational skills with high emotional intelligence. Excellent listener; inclusive, seeks broad input and feedback; frequent and effective feedback/follow-up
• Effective communication at all times. Experience in delivering complex messages, in a matrix organization, to a diverse audience with a track record of effective and influential presentations
• Proven team player with ability to navigate cross functionally
• Ability to build strong credibility at local, regional and global level, to effectively interact, providing direction, challenge and support whenever relevant
• Act as a role model for ethical behavior
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.