Kedrion Biopharma is recruiting an Ethics & Compliance Manager to enhance and maintain the Global Ethics and Compliance (E&C) System. Responsibilities include designing and implementing written guidelines, training programs, internal controls, and monitoring systems.
The role involves supporting both global and local projects, ensuring adherence to emerging regulatory requirements and fostering a culture of ethical practices within the organisation.
Join us in driving the development of sustainable and compliant solutions within this exciting and new opportunity.
Kedrion Biopharma is a biopharmaceutical company headquartered in Italy, which collects and fractionates blood plasma to produce and distribute worldwide plasma-derived therapies for use in treating and preventing serious diseases, disorders, and conditions.
Duties & Responsibilities Will Include:
* Completing and updating periodic compliance risks’ assessments.
* Developing and maintaining systems and processes for monitoring changes in applicable laws and regulations (including industry guidance and best practices) that are relevant to or impact the E&C System in the countries where Kedrion operates.
* Drafting and implementing compliance-related policies and procedures, keeping an oversight of version control, change tracking and effective roll-outs.
* Conducting training and executing communications initiatives.
* Designing and implementing compliance controls into Company’s processes.
* Presenting on E&C topics/initiatives during meetings with company’s internal and external stakeholders.
* Conducting and facilitating auditing and monitoring activities.
* Conducting and facilitating third-party due diligence activities, including review and approval processes.
* Implementing digital tools supporting compliance activities.
* Administering the Kedrion Global Speak Up Program and E&C investigations.
* Periodically reporting to the Management of the Company on the outcomes of the monitoring activities and other E&C initiatives.
* Supporting the Global Compliance Officer and the Global Ethics & Compliance Team in identifying areas of improvement for the Global Ethics & Compliance System, with an intent to focus on the Commercial Organization.
* Participating in the development of performance improvement projects (e.g., definition and measurement of compliance metrics).
* Partnering with Company Functions (e.g., Legal, Finance, IT, HR, Internal Audit, Quality, Commercial, etc.) to ensure that the E&C System is properly designed and effectively implemented in the different areas of the Kedrion Organization and to provide independent advice to manage compliance.
Skills & Experience:
We're looking for highly motivated and experienced people to drive the business forward. If you are passionate about ethical responsibility, then we would love to hear from you.
* Bachelor’s Degree
* Relevant compliance experience in pharma, biotech, or medical devices
* Understanding of the basic elements of an effective compliance program and guidance issued by the DoJ and OIG
* Strong communication and interpersonal skills (i.e., ability to express facts and ideas clearly and concisely, both orally and in writing)
* Strong skills in analytical thinking, specifically the ability to identify and define problems, collect data, establish facts, and develop substantiated conclusions.
* Excellent attention to detail and accuracy
* Ability to manage multiple projects requiring cross-functional collaboration and to work under multiple time deadlines
* Problem-solving and solutions orientation
* Maintain confidentiality in all matters
* Intermediate to advanced computer skills including Microsoft Office Suite (i.e., Excel, Word, Outlook, PowerPoint)
* Ability to work independently, under general guidance and supervision
* Ability to professionally interact with all levels of employees up to Executives, BODs, Attorneys, etc.
* Willingness and curiosity to learn
* Willingness and ability to travel as necessary (not to exceed 25%)
* Fluent English and Italian are required (knowledge of additional languages of countries where Kedrion operates is highly appreciated)
* Experience with regulations on Healthcare Compliance and interactions with Healthcare Stakeholders (Healthcare Professionals, Healthcare Organizations, Patients Organizations, Payors) (preferred but not required)
* Knowledge of Anti-bribery legislations (e.g., Foreign Corrupt Practices Act, UK Bribery Act, Italian Law Decree nr. 231/01) (preferred but not required)
* IAPP Certification (e.g., CIPP/US, CIPM, CIPT) (preferred but not required)
In Return We Offer:
* Competitive salary
* Annual bonus scheme
* 25 days holiday (plus bank holidays)
* Pension
* Life insurance
* On-site parking
* Employee assistance programme
* Virtual GP
* Cycle to work scheme
* Subsidised canteen
* Employee discounts and cash back
* Gym membership discounts
* Family-friendly policies
* Employee recognition programme
* Loyal service awards
In 2022, Kedrion joined forces with BPL (Bio Products Laboratory). Based in Elstree, BPL operates a targeted portfolio of successful plasma-derived products to treat rare diseases. There are nearly 1000 colleagues based at the campus, where a number of our life-enhancing plasma-derived products are manufactured.
With the combination of Kedrion and BPL, the company now becomes a global player in plasma derivatives and rare disease medicines employing more than 4,800 people worldwide. As a joint company, we function as a bridge between donors and the people who need treatment, and work on a global scale to expand patient access to plasma-derived therapies.
Please apply today for immediate consideration.
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