Easter Seals Jobs

Basic purpose of the job

The Quality and Compliance Lead (QCL) is the Quality and Compliance expert and drives GvP / GcP topics across the Boehringer Ingelheim organization to pro-actively manage Quality and Compliance across the drug/device lifecycle.

The role:

• Leads the organization to identify and mitigate risks throughout the drug/device lifecycle to ensure patient safety and data integrity.

• Initiates and manages any quality and compliance topics to continuously improve our Quality Management System.

• Provides quality and compliance consultancy to enable fast and efficient research and development, market authorizations and maintain licenses for our portfolio of products within a specific (R)OPU.

• Contributes R/OPU insights into the Global Quality Medicine Strategy and execute the strategy at R/OPU level.

• Act locally and think globally.

Accountabilities

Quality strategy and governance:

• Develop and maintain all aspects of the global Quality Management System and tailoring to the (R)OPU to comply with local regulatory requirements.

• Leads with the Head of QM the preparation of Quality Management Review reports and meetings

• Active collaboration in the set-up, development and implementation of quality objectives and Quality plans

• Deputise for the R/OPU Head of QM where applicable

Related performance indicators

• Changes to QMS elements implemented by planned dates

• QRMs performed as per schedule in (R)OPU

• Quality objectives and plans agreed by planned date

Culture and organization:

• Be a quality & compliance consultant and work collaboratively as a solution oriented, pragmatic partner to the Medicine functions and other applicable business partners, leading them to understand the quality and compliance requirements and implications for their business area

• Assess impact of Regulatory Intelligence Network (RIN) changes on Quality and Compliance processes and act and escalate topics accordingly

• Lead the understanding of Quality Culture by ensuring quality and compliance standards are understood and embedded into processes and practices early (Quality by Design)

• Active involvement and participation in local/ global/regional activities/topics and projects

Related performance indicators

• Behaviours based feedback from stakeholders

• Quality initiatives implemented based on planned dates

Processes and Procedures:

• Lead the implementation and maintenance of global procedures in a pragmatic, clear and concise way and ensure adherence to the local regulatory and business requirements. For example, lead the design / creation / retirement of local documents/ KMED assets as required

• Collaborate with Medicine functions in conducting R/OPU learning needs analysis (training, qualification)

• Communicate global changes into the (R)OPU as required to enable adoption of the new ways of working.

• Verification of translation of relevant topics as required

• Initiates updates of relevant process descriptions and guidelines as needed

Regulatory Inspections:

• Lead inspections end to end (inspection preparation, conduct and post inspection management), representing the Boehringer Ingelheim compliance position to regulatory authorities during inspections and ensuring inspection findings are addressed and responses provided.

• Ensure any lessons learned are implemented

Audits:

• Contribute to audits from inputting into the annual audit planning and ensuring audit findings are appropriately investigated and actions are effectively implemented.

• Ensure that lessons learnt are implemented

• Conduct audit activities as lead-; co- or Boehringer Ingelheim responsible auditor provided appropriate qualification is available, upon request (assignment) and under oversight of the global auditing leadership team

Related performance indicators

• Local documents released / retired as per plan / target dates

• Changes to QMS processes implemented by planned dates

• All inspection findings/ audit observations addressed as per plan

• No findings / observations relating to conduct of inspection / audit

• No re-curring audit observations

Supplier Management:

• Define requirements for services needed by (R)OPU in collaboration with Medicine Function.

• Management and oversight of suppliers effectively within specific (R)OPU liasing with Global Vendor Compliance Manager stakeholders (e.g. Medicine, Sourcing, Legal and Commercial Quality) from site qualification to the process end and Non Compliances/Corrective Action / Preventive Action (CAPA) Management.

• Perform periodic review of (R)OPU specific suppliers

The Compliance Manager executes the supplier management tasks and activities (qualification, oversight and termination activities) for the assigned suppliers in their region, as per global process.

Related performance indicators

• (R)OPU specific suppliers are in SQMS maintained as per SOP

Risk and issue management:

Quality Improvement:

• Continuously review and evaluate standards and processes for potential compliance gaps / risks / near misses in accordance with regulatory and legal requirements e.g. use Functional Quality Assessments to communicate to global GPO and update as required.

-Provide quality analysis, trending and optimisation capabilities across Medicine Functions.

Management of Non Compliances:

• Lead as the subject matter expert (in partnership with the business key stakeholders) in Non Compliance management and Issue Management processes. Ensure effective triaging, root cause analysis investigation and CAPA development delivering robust CAPAs

-Be a proactive member of the project team and Contribute holistic Quality and Compliance input as a Project Quality and Compliance Lead (PQCL) at the project/trial level, provided appropriate qualification is available and under the oversight of global.

Related performance indicators

• Implement Medicine-wide KRIs as per plan

• Implement CAPAs as per plan, CAPAs assessed as effective as per process

• Updated process aligned with regulatory and legal requirements as per plan

Regulatory and / or Organisational Requirements

Current knowledge in applicable regulatory processes and procedures with ability to assess the impact of these processes/ procedures in relation to GvP and GcP. The position requires the employee to be able to apply the regulatory requirements (Boehringer Ingelheim and Regulators) to GxP related situations in the product lifecycle, medical affairs activities, medical device and companion diagnostics and find / implement appropriate solutions and decisions.

Job Complexity

Highly evolving environment in the industry as well as the scientific and regulatory environment and multiple external and internal stakeholders. Require agility, accountability, timely decision making, communication and prioritization.

Interfaces

Cross functional Medicine Colleagues, in particular Clinical Operations, Translational Medicine, Pharmacovigilance, Drug Regulatory Affairs, Medical Affairs, Quality Assurance of other business areas, CTSU Medical Director. QM colleagues from all disciplines and various managerial levels. Potential interface with all Boehringer Ingelheim functions in GcP/ GvP related topics.Global, regional and local leaders within Medicine. Regulatory authorities, Vendors, Sourcing, Legal, IT

Medicine business functions, Quality departments in Development and Operations

Job Expertise

• Expert in ICH GcP and applicable regulations (several years experience in clinical trial management and/or in depth knowledge of clinical development process) or

• Expert in ICH GvP and applicable regulations (several years experience in pharmacovigilance and/or in depth knowledge of pharmacovigilance processes)

• Broad knowledge in applicable company processes, procedures and systems Non-Compliance (NC) and Corrective Action / Preventive Action (CAPA) management processes, incl. Root Cause Analysis methodologies

• Direct experience with / participation in regulatory authority inspections

• Experience with working within a highly matrix environment / organization

-5+years experience in Quality and Compliance related job

Job Impact

Failure to identify, communicate and document quality and compliance issues and risks may jeopardize patient safety and data integrity and delay market authorizations or effective maintenance of our licenses.The job operates in a complex continuously evolving business and regulatory environment in which it is often required to make significant risk-based decisions and provide guidance on issues to Medicine personnel including the different management levels and colleagues.

Minimum Education/Degree Requirements

Master's degree preferred or Bachelors in a life science or other scientific discipline with several years of work experience

Required Capabilities (Skills, Experience, Competencies)

Knowledge:

• QM processes and functional processes: level of understanding such role can provide appropriate Quality and compliance related advice in relation to the QM processes

• QMS: understanding of the sub-elements of QMS and how they link together such that role can fulfil QMS related accountability (see above)

• Quality by Design: in depth knowledge of QbD approaches such that role can provide appropriate QbD related advice in relation to QM and functional processes

• Boehringer Ingelheim organization & strategy: understand the Boehringer Ingelheim organization and our goals such that role can incorporate these topics whilst delivering accountabilities e.g. considering strategy and goals when providing advice within (R)OPU.

• R&D understanding: understand overall drug development process and Boehringer Ingelheim specific areas of focus (therapeutic areas) such that role can incorporate these topics whilst delivering accountabilities

• Digital suppliers: understand digital supplier such that role can incorporate these topics whilst delivering accountabilities e.g. provide advice on risks to data integrity through use of specific supplier and suggest ways to mitigate these risks

• New technologies: knowledge of specific technologies e.g. data collection technologies and the associated (potential) regulations, such that role can provide advice in their use within the (R)OPU

• External regulations: knowledge of the relevant regulatory requirements for QM and functional processes to be able to assess the risks for non-adherence to external regulations and provide mitigation strategies or how to address issues

Skills:

• Communication skills: able to communicate effectively clearly and concisely with all individuals across Boehringer Ingelheim regardless of their position or relationship

• Influencing & negotiating skills: able to clearly articulate options and their potential implications and reach an agreement with all individuals across Boehringer Ingelheim regardless of their position or relationship

• Leadership skills: able to lead Quality and Compliance topics and teams (including matrix or project teams) effectively to deliver the responsibilities effectively

• Data analytics: able to perform simple analyses and interpretation of data in order to enable decision making and to identify recommendations

• Critical thinking: able to draw reliable conclusions in order to make decisions or recommendations

• Presentation skills: able to design and deliver effective presentations to achieve the required outcomes

• Risk management: able to identify and manage risks effectively

-Project management: able to apply project management techniques to lead and deliver local or regional projects

QM Behaviours:

• Able to adopt and incorporate QM expected Behaviours into how role delivers its accountabilities including: being pragmatic, solution oriented, collaborative, customer focused, proactive assertive and decisive

• Ability to travel regionally and internationally as needed

• Required English speaking CEFR level : B2

Recruiter : Suzuki

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.