Compliance Partnerships Leader (f/m/d)

Compliance Partnerships Leader (f/m/d) – GCP / GVP / Quality Systems / PDMA / English

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Compliance Partnerships Leader.

Background:
This position is part of PDMA, Medical Alliances Operations, Compliance Partnership Chapter.

Key objectives are proactively identify compliance needs, lead and support the creation of solutions including processes or other initiatives to sustain the pharma license to operate and improve patient outcomes; Embed the appropriate environment within PDMA to enable compliance ensuring that Medical Affairs activities are executed efficiently, effectively and in accordance with pharma client SOPs, policies, regulatory requirements and guidelines.

The perfect candidate:
We are looking for candidates with technical experience in compliance focused on regulated processes (GVP/GCP) and strong knowledge of Quality Management Systems. In terms of specific competencies this candidate should demonstrate:

*Strong leadership, influencing, motivational and interpersonal skills
*Demonstrated consistent achievement of team delivery as per commitments and outcomes
*Communicates with energy and passion to engage and inspire others, able to define the best communication strategy and technique depending on the business needs

Tasks & Responsibilities:
* Lead and support the design and implementation of holistic, company-wide standards and solutions to establish the framework and the execution of PV compliance requirements for Market Research /Patient Support Programs (MAPs) and Digital Customer Engagement and Listening Activities (DiCELA) and Evidence Generation in accordance with Scientific Credibility standards (including Real World Evidence Scientific Projects). Engage and collaborate with the relevant stakeholders at all levels to ensure gaps are addressed.
* Oversee and embed compliance excellence within PDMA, including safety, quality, process efficiency improvement and risk management initiatives in accordance with Roche SOPs, policies, regulatory requirements and guidelines.
* Effectively represent PDMA with internal and external stakeholders in cross-functional working groups (including committees, cross-functional initiatives, etc.) to ensure that the needs of PDMA are considered and aligned with those of other functions.
* Communicate, provide leadership and guidance to Affiliates, Global Functions and other key stakeholders addressing PDMA related process requirements and regulations.
* Act as Subject Matter Expert (SME) during Inspections and Audits, ensure Inspection Readiness and support (or own) the preparation of responses to findings and the development and implementation of Corrective Actions and Preventive Actions (CAPA).
* As Functional training and process responsible in PDMA, ensure that the right PDMA audience is assigned to relevant trainings and foster an overall culture of adherence to quality and business requirements.

Must Haves:
* Life sciences degree or nursing equivalent or substantial experience in a clinical research/healthcare/pharma environment
* Ideally 7 to 10 years experience in the pharmaceutical or health sector (clinical trials, quality, safety)
* Experience in quality management with digital activities
* Extensive experience in GCP, GVP and healthcare compliance
* Fluency in written and spoken English
* Have appropriate knowledge of agile methodologies e.g. Scrum, Design Thinking, Lean etc.
* Demonstrates basic knowledge in digital technologies
* Have an overall understanding of the activities conducted in Medical Affairs
* Embed the Pharma Operating Principles in the way of working, including customer-centric mindset.
* Strong leadership, influencing, motivational and interpersonal skills
* Demonstrated consistent achievement of team delivery as per commitments and outcomes

Reference Nr.: 922134
Role: Compliance Partnerships Leader
Industrie: Pharma
Workplace: Basel
Pensum: 100%
Start: 02.01.2023
Duration: 12++
Deadline: 21.11.2022

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees