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 –

Under the supervision of the Global Compliance Officer, designs, implements and manages Ethics & Compliance (“E&C”) initiatives at global level and for specific markets in which Kedrion operates including, but not limited to, the following activities:

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 industry 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.

Present on E&C topics/initiatives during meetings with company’s internal and external stakeholders.

Conduct and facilitate auditing and monitoring activities.

Conduct and facilitate third party due diligence activities, including review and approval processes.

Implement digital tools supporting compliance activities.

Administer the Kedrion Global Speak Up Program and E&C investigations.

Periodically report to the Management of the Company on the outcomes of the monitoring activities and other E&C initiatives.

Supports 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.
Participates in the development of performance improvement projects (e.g. definition and measurement of compliance metrics,…).
Partners 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 to help you within the role –

We're looking for highly motivated and experienced people to drive the business forward. If you are passionate 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, listening and getting clarifications, answering questions)

Strong skills in analytical thinking, specifically, 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 with 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,…)

IAPP Certification (e.g., CIPP/US, CIPM, CIPT) (preferred but no

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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