Senior Manager, Standards & Governance (f/m/d)
Location
München | Germany
Job description
Job Description
For our office in Munich (in a hybrid working model) we are recruiting for a
Senior Manager, Standard & Governance (f/m/d)
About the role
The Senior Manager, Standard & Governance (f/m/d) is responsible to maintain and drive the governance and compliance within the affiliate, to implement and advise on applicable requirements, to anchor, evaluate and enhance the local business processes, and strengthen the compliance within the organization. He/She plays a key role to operationalize the local business processes that support the implementation of the corporate compliance program, working in close partnership with the affiliate Coporate compliance officer, as well as the peers S&G managers in the region, and the local functions and departments.
What You’ll Do
- Facilitate and coordinate the local implementation of Global Policies, SOPs and Guidances. Develop, implement and lead local trainings on these Policies, SOPs and Guidance
- Regularly assess local organization acumen, develop and implement a local training plan, specific or tailored to the stakeholder needs, provide training and secure knowledge transfer
- Anticipate the future needs, based on the business evolution and/or the compliance environment (internal and external)
- Develop effective training plans to address key monitoring or audit findings, remediations adoptions by the organization.
Build and keep a strong and constructive partnership with the Compliance Officer, through
- Effective conduction of the compliance monitoring program, with oversights on results and implications
- Identify and propose potential improvements or remediation to compliance processes locally
- Leverage effective communication channels (such as Compliance Open House call), and ensure a robust knowledge transfer
Be and Act as the local coordinator for all S&G efforts and evolution in the German organization
- Plan, coordinate and drive the Governance meetings within the organization, in particular with Leadership Team and key responsible functions in the affiliate (such as Regulatory, Quality, PV and Safety)
- Prepare, coordinate and lead the local internal audits, in close cooperation with the leadership team and the functional leads; Coordinate and drive the resulting remediation plans, and their effective transfer within the organization
- Act as the point of contact for the transparency requirements within the affiliate, for queries, analysis and disclosure in partnership with the Global Business Services team, ensure on time preparation and disclosure as per German regulations
- Be the local expert on Data Privacy (DP) matters, act as the point of contact with DP Officer of Biogen and secure local implementation of development and initiative on DP. Be the local consultant and expert on DP when it comes to project and local intitiatives from the business, advising on risks and DP regulation
- Regularly assess the effectiveness of the internal business processes within the affiliate, with focus on the ones that are governed by Policies, SOPs and Guidance for External Stakeholder Engagements. Drive continuous improvement in these processes, identify pain points and root cause, design solutions and test/roll out
- Communication excellence within the organization, especially in time of new Policies, Trainings and when evolution on standard and governance areas (such as new process, system change/upgrade, new working instructions).
- Effectivelly coordinate the local S&G efforts, be and act as the person to go:
- To define the clear objectives, secure the execution and deliveries, with effective partnership amongst internal stakeholders
- To coordinate the S&G efforts, grow the function experience and footprint, and actively contribute to actionable development plans for the function
Who you are
You possess a keen eye for detail and have a good understanding for business need.You are able to change perspective, to effectively communicate standards, policies and procedures and deliver sustainable, pragmatic solutions. You foster a culture of adherence to standards and best practices within the Biotech industry and ensure that the organization remains compliant and operates effectively in a dynamic environment.
Qualifications
Requirements
- Master's degree or equivalent education
- A minimum of 7 years of experience in a similar role, ideally in the pharmaceutical or biotechnology industries
- Knowledge of Healthcare Compliance Program requirements (elements, requirements, implementation and execution) or experience in other defined governance roles (Audit, GxP, Regulatory Affairs, Business Compliance etc.)
- Sound experience with Policies, SOP and procedure drafting, management, implementation and improvement
- Good and deep understanding of business processes as well as expertise in operationalization, coordination and enhancement of processes
- Competence and seniority to consult, design, communicate, train and manage process implementation. Ability to root cause complex process.
- Strong ability with project management and change management, with strategy and excellence in execution and communication.
- Ability to find agile concept, pragmatic approach, target-oriented solutions, in a compliant way.
- Relevant cross functional work experience, strong coordination, drive empowerment, with strategic approach, lead in the matrix
- Fluency in German and English are essential
Additional Information
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts
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